Trial Outcomes & Findings for Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study (NCT NCT05262920)
NCT ID: NCT05262920
Last Updated: 2026-01-28
Results Overview
Visual analogue scale (0-100) uses an unlabeled line with scores further to the right indicating higher scores and increased pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
Baseline to 24 weeks
Results posted on
2026-01-28
Participant Flow
Recruitment began March 2022 and completed in June 2023. The recruitment sites were two academic medical centers maternity units.
Two participants were screened and were excluded from the study. All other participants were screened and enrolled in the study.
Participant milestones
| Measure |
The BSM Intervention
Guided by the Individual and Family Self-Management Theory, the Lucas team developed the Breastfeeding and BNP Self-Management (BSM) intervention. The BSM intervention uses a cloud-based platform, links to educational modules, and daily journaling, to provide women uniform best practice knowledge and skills for BF and BNP self-management.
Strategies include guided imagery, therapeutic breathing, mindfulness, relaxation, non-pharmacological interventions that are integrated within the self-management process such as goal-setting, self-monitoring, problem-solving, and social support through texting.
The BSM Intervention: The BSM intervention entailed a daily electronic journal for monitoring BF and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support and to promote personalized goal-setting and problem-solving, and hyperlinks to eight uniform BNP educational modules (knowledge and skills) and online resources. 1. Fundamentals of BF (FBF), 2. Deep breathing (DB), 3. BNP non-pharmacological strategies (BNPS), 4. Guided imagery (GI), 5. Pain neurophysiology specifically related to BF (PN-BF), 6. Catastrophizing, 7. Stress reactivity, and 8. Common pumping issues and interventions (CPI).
|
Attention Control
Attention control (AC) participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the Centers for Disease Control (CDC) HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
128
|
|
Overall Study
COMPLETED
|
77
|
97
|
|
Overall Study
NOT COMPLETED
|
45
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study
Baseline characteristics by cohort
| Measure |
The BSM Intervention
n=122 Participants
Guided by the Individual and Family Self-Management Theory, the Lucas team developed the Breastfeeding and BNP Self-Management (BSM) intervention. The BSM intervention uses a cloud-based platform, links to educational modules, and daily journaling, to provide women uniform best practice knowledge and skills for BF and BNP self-management.
Strategies include guided imagery, therapeutic breathing, mindfulness, relaxation, non-pharmacological interventions that are integrated within the self-management process such as goal-setting, self-monitoring, problem-solving, and social support through texting.
The BSM Intervention: The BSM intervention entailed a daily electronic journal for monitoring BF and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support and to promote personalized goal-setting and problem-solving, and hyperlinks to eight uniform BNP educational modules (knowledge and skills) and online resources. 1. Fundamentals of BF (FBF), 2. Deep breathing (DB), 3. BNP non-pharmacological strategies (BNPS), 4. Guided imagery (GI), 5. Pain neurophysiology specifically related to BF (PN-BF), 6. Catastrophizing, 7. Stress reactivity, and 8. Common pumping issues and interventions (CPI).
|
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.16 years
STANDARD_DEVIATION 4.63 • n=41 Participants
|
30.32 years
STANDARD_DEVIATION 5.19 • n=1581 Participants
|
30.24 years
STANDARD_DEVIATION 4.91 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=41 Participants
|
128 Participants
n=1581 Participants
|
250 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=41 Participants
|
36 Participants
n=1581 Participants
|
71 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=41 Participants
|
92 Participants
n=1581 Participants
|
179 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=41 Participants
|
27 Participants
n=1581 Participants
|
56 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=41 Participants
|
85 Participants
n=1581 Participants
|
159 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
122 Participants
n=41 Participants
|
128 Participants
n=1581 Participants
|
250 Participants
n=4626 Participants
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
|
36.55 units on a scale
STANDARD_DEVIATION 25.05 • n=41 Participants
|
39.43 units on a scale
STANDARD_DEVIATION 25.28 • n=1581 Participants
|
38.03 units on a scale
STANDARD_DEVIATION 25.16 • n=4626 Participants
|
|
Brief Pain Inventory (BPI) Pain Intensity Scale
|
3.88 units on a scale
STANDARD_DEVIATION 1.96 • n=41 Participants
|
3.79 units on a scale
STANDARD_DEVIATION 2.04 • n=1581 Participants
|
3.83 units on a scale
STANDARD_DEVIATION 2.00 • n=4626 Participants
|
|
Brief Pain Inventory (BPI) Interference Scale
|
3.38 units on a scale
STANDARD_DEVIATION 2.4 • n=41 Participants
|
3.55 units on a scale
STANDARD_DEVIATION 2.54 • n=1581 Participants
|
3.46 units on a scale
STANDARD_DEVIATION 2.47 • n=4626 Participants
|
|
Breastfeeding Exclusivity Participation Rate
|
119 Participants
n=41 Participants
|
118 Participants
n=1581 Participants
|
237 Participants
n=4626 Participants
|
|
Breastfeeding Self-Efficacy Scale
|
45.28 units on a scale
STANDARD_DEVIATION 13.71 • n=41 Participants
|
45.49 units on a scale
STANDARD_DEVIATION 13.01 • n=1581 Participants
|
45.38 units on a scale
STANDARD_DEVIATION 13.36 • n=4626 Participants
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
|
51.56 t-score
STANDARD_DEVIATION 9.1 • n=41 Participants
|
51.27 t-score
STANDARD_DEVIATION 8.37 • n=1581 Participants
|
51.41 t-score
STANDARD_DEVIATION 8.73 • n=4626 Participants
|
|
Edinburgh Postnatal Depression Scale
|
5.56 units on a scale
STANDARD_DEVIATION 4.62 • n=41 Participants
|
6.03 units on a scale
STANDARD_DEVIATION 4.92 • n=1581 Participants
|
5.79 units on a scale
STANDARD_DEVIATION 4.77 • n=4626 Participants
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
|
53.99 T-score
STANDARD_DEVIATION 9.63 • n=41 Participants
|
54.95 T-score
STANDARD_DEVIATION 9.26 • n=1581 Participants
|
54.47 T-score
STANDARD_DEVIATION 9.44 • n=4626 Participants
|
|
Perceived Stress Scale10 Form V.09/16/13
|
12.94 units on a scale
STANDARD_DEVIATION 6.66 • n=41 Participants
|
12.93 units on a scale
STANDARD_DEVIATION 6.15 • n=1581 Participants
|
12.93 units on a scale
STANDARD_DEVIATION 6.40 • n=4626 Participants
|
|
Sleep Disturbance Patient-Reported Outcomes Measurement Information (PROMIS) Short Form v1.0 - 6a
|
52.35 T-score
STANDARD_DEVIATION 9.16 • n=41 Participants
|
54.13 T-score
STANDARD_DEVIATION 9.09 • n=1581 Participants
|
53.22 T-score
STANDARD_DEVIATION 9.12 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: The visual analogue scale (0-100) will quantify breast and nipple pain severity during breastfeeding at all data points.
Visual analogue scale (0-100) uses an unlabeled line with scores further to the right indicating higher scores and increased pain
Outcome measures
| Measure |
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Baseline
|
36.55 units on a scale
Standard Error 25.05
|
39.43 units on a scale
Standard Error 25.28
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 1
|
36.93 units on a scale
Standard Error 27.61
|
44.31 units on a scale
Standard Error 25.34
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 2
|
25.68 units on a scale
Standard Error 25.79
|
33.8 units on a scale
Standard Error 26.26
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 3
|
18.26 units on a scale
Standard Error 21.19
|
31.42 units on a scale
Standard Error 24.7
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 6
|
8.86 units on a scale
Standard Error 18.49
|
17.2 units on a scale
Standard Error 22.1
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 9
|
5.86 units on a scale
Standard Error 14.86
|
12.21 units on a scale
Standard Error 19.19
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 12
|
6.22 units on a scale
Standard Error 14.72
|
7.96 units on a scale
Standard Error 14.53
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 18
|
7.68 units on a scale
Standard Error 17.52
|
4.33 units on a scale
Standard Error 11.23
|
|
Visual Analogue Scale for Breast and Nipple Pain Severity
Week 24
|
5.75 units on a scale
Standard Error 15.14
|
6.54 units on a scale
Standard Error 13.75
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: The Brief Pain Inventory pain severity sum score (item 3, 4, 5, and 6) will quantify breast and nipple pain during breastfeeding at all data points.
The Brief Pain Inventory pain intensity sum score of 4 items (3, 4, 5, and 6). Each item is scored 0-10, the pain intensity sum score ranges from 0-40. The higher the score the worse the pain. A composite score of the average is sometimes reported. Factor analysis verified the two separate factors, pain intensity and interference, found in the previous study. Internal stability (Cronbach alpha) was also examined in this study. Alphas showed good internal consistency, ranging from 0.80 to 0.87 for the four pain intensity items.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Brief Pain Inventory Pain Intensity Scale
Baseline
|
3.79 score on a scale
Standard Deviation 2.04
|
3.88 score on a scale
Standard Deviation 1.96
|
|
Brief Pain Inventory Pain Intensity Scale
Week 2
|
3.24 score on a scale
Standard Deviation 1.92
|
2.89 score on a scale
Standard Deviation 1.92
|
|
Brief Pain Inventory Pain Intensity Scale
Week 1
|
3.72 score on a scale
Standard Deviation 1.81
|
3.56 score on a scale
Standard Deviation 2.07
|
|
Brief Pain Inventory Pain Intensity Scale
Week 18
|
1.84 score on a scale
Standard Deviation 1.42
|
1.89 score on a scale
Standard Deviation 1.24
|
|
Brief Pain Inventory Pain Intensity Scale
Week 24
|
1.76 score on a scale
Standard Deviation 1.19
|
1.81 score on a scale
Standard Deviation 1.33
|
|
Brief Pain Inventory Pain Intensity Scale
Week 3
|
2.83 score on a scale
Standard Deviation 1.89
|
2.52 score on a scale
Standard Deviation 1.77
|
|
Brief Pain Inventory Pain Intensity Scale
Week 6
|
2.19 score on a scale
Standard Deviation 1.56
|
2.38 score on a scale
Standard Deviation 1.75
|
|
Brief Pain Inventory Pain Intensity Scale
Week 9
|
1.93 score on a scale
Standard Deviation 1.46
|
2.00 score on a scale
Standard Deviation 1.52
|
|
Brief Pain Inventory Pain Intensity Scale
Week 12
|
1.86 score on a scale
Standard Deviation 1.44
|
1.64 score on a scale
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: Baseline to 24 weeks.Population: The Brief Pain Inventory pain interference sum score (items 9a - 9g) will quantify breast and nipple pain during breastfeeding effect on everyday life at all data points.
The Brief Pain Inventory Pain Interference score is the average sum score of 7 items 9a - 9g. Each item is scored 0-5, with a total score of 0-35. Higher scores mean worse pain. A composite score of the average is sometimes reported. Factor analysis verified the two separate factors, pain intensity and interference, found in the previous study. Internal stability (Cronbach alpha) was also examined in this study. Alphas showed good internal consistency, ranging from 0.89 to 0.92 for the seven interference item.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Brief Pain Inventory Interference Scale
Baseline
|
3.55 score on a scale
Standard Deviation 2.54
|
3.38 score on a scale
Standard Deviation 2.40
|
|
Brief Pain Inventory Interference Scale
Week 1
|
2.46 score on a scale
Standard Deviation 2.27
|
2.27 score on a scale
Standard Deviation 2.34
|
|
Brief Pain Inventory Interference Scale
Week 2
|
2.00 score on a scale
Standard Deviation 2.40
|
1.92 score on a scale
Standard Deviation 2.47
|
|
Brief Pain Inventory Interference Scale
Week 3
|
1.36 score on a scale
Standard Deviation 2.02
|
1.25 score on a scale
Standard Deviation 2.06
|
|
Brief Pain Inventory Interference Scale
Week 6
|
1.11 score on a scale
Standard Deviation 2.31
|
1.29 score on a scale
Standard Deviation 2.42
|
|
Brief Pain Inventory Interference Scale
Week 9
|
0.95 score on a scale
Standard Deviation 2.11
|
1.09 score on a scale
Standard Deviation 2.42
|
|
Brief Pain Inventory Interference Scale
Week 12
|
0.89 score on a scale
Standard Deviation 2.01
|
1.15 score on a scale
Standard Deviation 2.7
|
|
Brief Pain Inventory Interference Scale
Week 18
|
0.63 score on a scale
Standard Deviation 1.5
|
1.18 score on a scale
Standard Deviation 2.60
|
|
Brief Pain Inventory Interference Scale
Week 24
|
0.92 score on a scale
Standard Deviation 2.19
|
1.11 score on a scale
Standard Deviation 2.47
|
PRIMARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Participants reported BNP severity using a visual analogue scale (0 - 100) at baseline and across time. Participants' cumulative BNP (baseline, +1 week, + 2 weeks, +3 weeks, + 6 weeks, + 9 weeks, +12 weeks, +18 weeks, +24 weeks, 0 - 900)
Each weekly score uses the visual analogue score of 0-100. Cumulative Breast and Nipple Pain (BNP) is calculated each week as a summed additive score. Participants' cumulative BNP (baseline +1 week, + 2 weeks, + 3 weeks, + 6 weeks, + 9 weeks, + 12 weeks, +18 weeks, 24 weeks, 0 - 900). Higher cumulative scores represent greater BNP severity. Only individuals who remain in the study scores are reported.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Cumulative Breast and Nipple Pain Scores
Baseline
|
39.43 units on a scale
Standard Deviation 25.28
|
36.55 units on a scale
Standard Deviation 25.05
|
|
Cumulative Breast and Nipple Pain Scores
1 Week
|
84.36 units on a scale
Standard Deviation 45.1
|
72.47 units on a scale
Standard Deviation 46.17
|
|
Cumulative Breast and Nipple Pain Scores
2 Weeks
|
117.64 units on a scale
Standard Deviation 63.76
|
98.57 units on a scale
Standard Deviation 62.22
|
|
Cumulative Breast and Nipple Pain Scores
3 Weeks
|
148.94 units on a scale
Standard Deviation 80.14
|
115.63 units on a scale
Standard Deviation 77.25
|
|
Cumulative Breast and Nipple Pain Scores
6 Weeks
|
166.58 units on a scale
Standard Deviation 92.43
|
126.59 units on a scale
Standard Deviation 87.53
|
|
Cumulative Breast and Nipple Pain Scores
9 Weeks
|
179.78 units on a scale
Standard Deviation 104.46
|
132.32 units on a scale
Standard Deviation 92.50
|
|
Cumulative Breast and Nipple Pain Scores
12 Weeks
|
188.78 units on a scale
Standard Deviation 111.35
|
141.54 units on a scale
Standard Deviation 101.90
|
|
Cumulative Breast and Nipple Pain Scores
18 Weeks
|
195.77 units on a scale
Standard Deviation 114.62
|
150.85 units on a scale
Standard Deviation 115.14
|
|
Cumulative Breast and Nipple Pain Scores
24 Weeks
|
202.38 units on a scale
Standard Deviation 122.25
|
160.37 units on a scale
Standard Deviation 124.95
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Examine the effect of the BSM intervention on secondary outcomes of BF exclusivity. BF exclusivity is for the infant to receive only breast milk from the breast or bottle for al feeding.
The number of participants who self-reported breastfeeding exclusivity (providing only breast milk and no formula) their infant.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Breastfeeding Exclusivity Participation Rate
Week 12
|
58 Participants
|
43 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 18
|
55 Participants
|
37 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 24
|
55 Participants
|
41 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 9
|
61 Participants
|
43 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Baseline Exclusive Breastfeeding (EBF)
|
118 Participants
|
119 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 1
|
74 Participants
|
67 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 2
|
70 Participants
|
56 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 3
|
57 Participants
|
50 Participants
|
|
Breastfeeding Exclusivity Participation Rate
Week 6
|
61 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: The Breastfeeding Self-Efficacy Scale was completed each week by participants retained in the study.
Breastfeeding Self-Efficacy Scale is a 14 item scale with 5-point Likert scale (1-5). Score Range: 14-70, with higher scores (\>50) indicate greater breastfeeding self-efficacy.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Breastfeeding Self-Efficacy Scale
Baseline
|
45.49 score on a scale
Standard Deviation 13.01
|
45.28 score on a scale
Standard Deviation 13.71
|
|
Breastfeeding Self-Efficacy Scale
Week 1
|
51.26 score on a scale
Standard Deviation 13.07
|
51.44 score on a scale
Standard Deviation 13.48
|
|
Breastfeeding Self-Efficacy Scale
Week 2
|
51.62 score on a scale
Standard Deviation 14.32
|
53.24 score on a scale
Standard Deviation 14.04
|
|
Breastfeeding Self-Efficacy Scale
Week 3
|
51.90 score on a scale
Standard Deviation 13.50
|
53.57 score on a scale
Standard Deviation 14.07
|
|
Breastfeeding Self-Efficacy Scale
Week 6
|
54.10 score on a scale
Standard Deviation 13.64
|
54.55 score on a scale
Standard Deviation 14.84
|
|
Breastfeeding Self-Efficacy Scale
Week 9
|
54.91 score on a scale
Standard Deviation 14.95
|
54.94 score on a scale
Standard Deviation 14.94
|
|
Breastfeeding Self-Efficacy Scale
Week 12
|
55.13 score on a scale
Standard Deviation 15.31
|
56.03 score on a scale
Standard Deviation 14.54
|
|
Breastfeeding Self-Efficacy Scale
Week 18
|
55.80 score on a scale
Standard Deviation 15.63
|
57.24 score on a scale
Standard Deviation 13.43
|
|
Breastfeeding Self-Efficacy Scale
Week 24
|
54.16 score on a scale
Standard Deviation 16.23
|
54.31 score on a scale
Standard Deviation 16.57
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Anxiety PROMIS measure was completed each week by participants retained in the study.
The PROMIS Short Form v1.0 - Anxiety 6a is a 6-item Likert Scale (1-5, never - always). Total raw score range from 6-30. Raw scores are converted to a T-score. The T-score of 50 is the population mean and the average for the US population with a standard deviation of 10. The T-score of 60 is indicative of sub-clinical or elevated levels of anxiety. PROMIS Anxiety shows moderate to strong correlations with Generalized Anxiety Disorder 7-item scale and Hospital Anxiety and Depression Scale-Anxiety.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Baseline
|
51.27 T-score
Standard Deviation 8.37
|
51.56 T-score
Standard Deviation 9.10
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 1
|
49.81 T-score
Standard Deviation 8.72
|
48.35 T-score
Standard Deviation 8.71
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 2
|
48.36 T-score
Standard Deviation 8.34
|
47.02 T-score
Standard Deviation 8.29
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 3
|
48.49 T-score
Standard Deviation 8.29
|
46.31 T-score
Standard Deviation 7.55
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 6
|
46.58 T-score
Standard Deviation 8.09
|
46.71 T-score
Standard Deviation 7.62
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 9
|
46.54 T-score
Standard Deviation 8.08
|
46.48 T-score
Standard Deviation 8.31
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 12
|
47.45 T-score
Standard Deviation 8.86
|
46.50 T-score
Standard Deviation 7.90
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 18
|
47.23 T-score
Standard Deviation 8.99
|
47.23 T-score
Standard Deviation 8.59
|
|
Anxiety Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 24
|
47.63 T-score
Standard Deviation 8.58
|
47.48 T-score
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Edinburgh Postnatal Depression Scale was completed each week by participants retained in the study.
Edinburgh Postnatal Depression Scale is a 10-item questionnaire with a 0-3 Likert scale and a total score range from 0 to 30. A score of 10 or more may indicate possible depression and a score of 13 or higher may be used to identify women with higher depression levels.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Edinburgh Postnatal Depression Scale
Week 1
|
5.76 score on a scale
Standard Deviation 4.32
|
4.56 score on a scale
Standard Deviation 3.97
|
|
Edinburgh Postnatal Depression Scale
Baseline
|
6.03 score on a scale
Standard Deviation 4.92
|
5.56 score on a scale
Standard Deviation 4.62
|
|
Edinburgh Postnatal Depression Scale
Week 2
|
4.50 score on a scale
Standard Deviation 3.84
|
4.05 score on a scale
Standard Deviation 3.81
|
|
Edinburgh Postnatal Depression Scale
Week 3
|
4.34 score on a scale
Standard Deviation 4.13
|
3.15 score on a scale
Standard Deviation 3.36
|
|
Edinburgh Postnatal Depression Scale
Week 6
|
3.52 score on a scale
Standard Deviation 3.75
|
3.45 score on a scale
Standard Deviation 3.40
|
|
Edinburgh Postnatal Depression Scale
Week 9
|
3.34 score on a scale
Standard Deviation 3.75
|
2.84 score on a scale
Standard Deviation 3.51
|
|
Edinburgh Postnatal Depression Scale
Week 12
|
3.61 score on a scale
Standard Deviation 4.00
|
3.00 score on a scale
Standard Deviation 3.22
|
|
Edinburgh Postnatal Depression Scale
Week 18
|
3.34 score on a scale
Standard Deviation 3.57
|
3.42 score on a scale
Standard Deviation 3.69
|
|
Edinburgh Postnatal Depression Scale
Week 24
|
3.57 score on a scale
Standard Deviation 3.91
|
4.22 score on a scale
Standard Deviation 4.73
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Fatigue PROMIS measure was completed each week by participants retained in the study.
The PROMIS Short Form v1.0 - Fatigue 6a is a 6-item Likert Scale (1-5, never - always). Total raw score ranges from 6-30. Raw scores are converted to a T-score. The T-score of 50 is the population mean and the average for the US population with a standard deviation of 10. The T-score of 60 is indicative of elevated levels of fatigue.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Baseline
|
54.95 T-score
Standard Deviation 9.26
|
53.99 T-score
Standard Deviation 9.63
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 1
|
54.48 T-score
Standard Deviation 9.32
|
51.72 T-score
Standard Deviation 10.62
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 2
|
52.26 T-score
Standard Deviation 9.42
|
50.98 T-score
Standard Deviation 10.25
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 12
|
48.82 T-score
Standard Deviation 9.12
|
48.86 T-score
Standard Deviation 9.82
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 3
|
52.59 T-score
Standard Deviation 8.98
|
49.84 T-score
Standard Deviation 9.89
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 6
|
50.46 T-score
Standard Deviation 8.92
|
48.46 T-score
Standard Deviation 10.01
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 9
|
49.81 T-score
Standard Deviation 9.18
|
47.72 T-score
Standard Deviation 9.56
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 18
|
49.53 T-score
Standard Deviation 9.24
|
48.82 T-score
Standard Deviation 9.61
|
|
Fatigue Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form 6a
Week 24
|
50.24 T-score
Standard Deviation 10.01
|
50.06 T-score
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Perceived Stress Scale measure was completed each week by participants retained in the study.
The Perceived Stress Scale (PSS-10) is a 10-item questionnaire is a 10-item Likert Scale from 0 ("Never") to 4 ("Very Often"). The total scores range from 0-40. To calculate a total PSS score, responses to the four positively stated items (items 4, 5, 7 and 8) first need to be reversed (i.e. 0 =\> 4; 1 =\> 3; 2 =\> 2; 3 =\> 1; 4 =\> 0). Higher scores indicate higher levels of perceived stress.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Perceived Stress Scale10 Form V.09/16/13
Baseline
|
12.93 score on a scale
Standard Deviation 6.15
|
12.94 score on a scale
Standard Deviation 6.66
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 1
|
12.68 score on a scale
Standard Deviation 6.26
|
11.52 score on a scale
Standard Deviation 6.73
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 2
|
11.44 score on a scale
Standard Deviation 6.30
|
10.71 score on a scale
Standard Deviation 6.09
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 3
|
11.60 score on a scale
Standard Deviation 6.05
|
9.51 score on a scale
Standard Deviation 6.04
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 6
|
10.33 score on a scale
Standard Deviation 6.03
|
10.33 score on a scale
Standard Deviation 6.16
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 9
|
9.88 score on a scale
Standard Deviation 6.17
|
10.10 score on a scale
Standard Deviation 6.17
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 12
|
10.22 score on a scale
Standard Deviation 6.19
|
10.52 score on a scale
Standard Deviation 6.38
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 18
|
10.96 score on a scale
Standard Deviation 6.09
|
11.15 score on a scale
Standard Deviation 6.66
|
|
Perceived Stress Scale10 Form V.09/16/13
Week 24
|
11.30 score on a scale
Standard Deviation 6.70
|
11.39 score on a scale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Sleep PROMIS measure was completed each week by participants retained in the study.
The PROMIS Short Form v1.0 - Sleep Disturbance 6a is a 6-item Likert Scale (1-5, never - always). Total raw score ranges from 6-30. Raw scores are converted to a T-score. The T-score of 50 is the population mean and the average for the US population with a standard deviation of 10. The T-score of 60 is indicative of increase sleep disturbances.
Outcome measures
| Measure |
Attention Control
n=128 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
Attention Control
n=122 Participants
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Baseline
|
54.13 T-Score
Standard Deviation 9.09
|
52.35 T-Score
Standard Deviation 9.16
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 1
|
50.69 T-Score
Standard Deviation 8.45
|
49.32 T-Score
Standard Deviation 7.38
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 2
|
48.91 T-Score
Standard Deviation 7.86
|
48.10 T-Score
Standard Deviation 6.96
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 3
|
48.72 T-Score
Standard Deviation 8.24
|
47.44 T-Score
Standard Deviation 8.01
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 6
|
47.79 T-Score
Standard Deviation 8.27
|
45.41 T-Score
Standard Deviation 7.51
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 9
|
47.01 T-Score
Standard Deviation 8.57
|
45.65 T-Score
Standard Deviation 7.05
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 12
|
47.61 T-Score
Standard Deviation 8.81
|
46.10 T-Score
Standard Deviation 7.07
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 18
|
48.34 T-Score
Standard Deviation 8.66
|
47.99 T-Score
Standard Deviation 6.70
|
|
Sleep Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance 6a
Week 24
|
47.70 T-Score
Standard Deviation 7.77
|
48.49 T-Score
Standard Deviation 8.81
|
Adverse Events
The BSM Intervention
Serious events: 39 serious events
Other events: 33 other events
Deaths: 0 deaths
Attention Control
Serious events: 36 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The BSM Intervention
n=122 participants at risk
Guided by the Individual and Family Self-Management Theory, the Lucas team developed the Breastfeeding and BNP Self-Management (BSM) intervention. The BSM intervention uses a cloud-based platform, links to educational modules, and daily journaling, to provide women uniform best practice knowledge and skills for BF and BNP self-management.
Strategies include guided imagery, therapeutic breathing, mindfulness, relaxation, non-pharmacological interventions that are integrated within the self-management process such as goal-setting, self-monitoring, problem-solving, and social support through texting.
The BSM Intervention: The BSM intervention entailed a daily electronic journal for monitoring BF and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support and to promote personalized goal-setting and problem-solving, and hyperlinks to eight uniform BNP educational modules (knowledge and skills) and online resources. 1. Fundamentals of BF (FBF), 2. Deep breathing (DB), 3. BNP non-pharmacological strategies (BNPS), 4. Guided imagery (GI), 5. Pain neurophysiology specifically related to BF (PN-BF), 6. Catastrophizing, 7. Stress reactivity, and 8. Common pumping issues and interventions (CPI).
|
Attention Control
n=128 participants at risk
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
|
|---|---|---|
|
Blood and lymphatic system disorders
Heart Palpitations
|
0.82%
1/122 • Number of events 2 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.00%
0/128 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Endocrine disorders
Thyroid Evaluation and Surgery
|
0.82%
1/122 • Number of events 2 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
2.3%
3/128 • Number of events 4 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Pregnancy, puerperium and perinatal conditions
Preclampsia and Hypertension
|
4.9%
6/122 • Number of events 6 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
5.5%
7/128 • Number of events 7 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Renal and urinary disorders
Urinary Tract Complications
|
0.82%
1/122 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
1.6%
2/128 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Nervous system disorders
Headache
|
0.00%
0/122 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.78%
1/128 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Infections and infestations
Infections and Abscess
|
1.6%
2/122 • Number of events 2 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.78%
1/128 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Injury, poisoning and procedural complications
Musculoskeletal
|
2.5%
3/122 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
3.1%
4/128 • Number of events 4 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
2.5%
3/122 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
5.5%
7/128 • Number of events 7 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Reproductive system and breast disorders
Mastitis and Nipple Infections
|
4.1%
5/122 • Number of events 7 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.78%
1/128 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Infant Illness
|
3.3%
4/122 • Number of events 4 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.78%
1/128 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Immune system disorders
Rash
|
0.82%
1/122 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
1.6%
2/128 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal Pain and Hemorrhoids
|
1.6%
2/122 • Number of events 2 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
2.3%
3/128 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Infections and infestations
General illness and infections
|
2.5%
3/122 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
1.6%
2/128 • Number of events 2 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Infections and infestations
Sexual Transmitted Infections
|
1.6%
2/122 • Number of events 2 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.00%
0/128 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Reproductive system and breast disorders
Birth Control Complications
|
0.82%
1/122 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.78%
1/128 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum Complications
|
2.5%
3/122 • Number of events 3 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.78%
1/128 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
|
Surgical and medical procedures
Removal of Breast Mass
|
0.82%
1/122 • Number of events 1 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
0.00%
0/128 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
|
Other adverse events
| Measure |
The BSM Intervention
n=122 participants at risk
Guided by the Individual and Family Self-Management Theory, the Lucas team developed the Breastfeeding and BNP Self-Management (BSM) intervention. The BSM intervention uses a cloud-based platform, links to educational modules, and daily journaling, to provide women uniform best practice knowledge and skills for BF and BNP self-management.
Strategies include guided imagery, therapeutic breathing, mindfulness, relaxation, non-pharmacological interventions that are integrated within the self-management process such as goal-setting, self-monitoring, problem-solving, and social support through texting.
The BSM Intervention: The BSM intervention entailed a daily electronic journal for monitoring BF and BNP with feedings, bi-weekly texting for 6 weeks from a research nurse for informational support and to promote personalized goal-setting and problem-solving, and hyperlinks to eight uniform BNP educational modules (knowledge and skills) and online resources. 1. Fundamentals of BF (FBF), 2. Deep breathing (DB), 3. BNP non-pharmacological strategies (BNPS), 4. Guided imagery (GI), 5. Pain neurophysiology specifically related to BF (PN-BF), 6. Catastrophizing, 7. Stress reactivity, and 8. Common pumping issues and interventions (CPI).
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Attention Control
n=128 participants at risk
Attention control participants will receive equivalent attention as the BSM group. The fourth-trimester care based on the CDC HEAR HER campaign and infant health information modules will be provided through the REDCap link.
Attention Control: The Attention Control and Intervention groups both receive fourth-trimester care videos. The educational modules are the following: Urgent maternal warning signs, caring for the maternal body after birth; infant care; COVID-19 and infant health prevention; maternal and infant immunization; infant safety in the home; maternal and infant dietary recommendations; and national and health resources to support BF in the workplace
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Pregnancy, puerperium and perinatal conditions
Postnatal Depression
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25.4%
31/122 • Number of events 57 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
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31.2%
40/128 • Number of events 85 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
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Psychiatric disorders
Suicide Consideration
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7.4%
9/122 • Number of events 13 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
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10.9%
14/128 • Number of events 18 • Baseline to 24 weeks
Our definitions did not differ from the clinical trials.gov definitions.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place