Trial Outcomes & Findings for Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support (NCT NCT04598165)
NCT ID: NCT04598165
Last Updated: 2024-08-15
Results Overview
Death during 1st 28 days of life
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5020 participants
Primary outcome timeframe
28 days postpartum
Results posted on
2024-08-15
Participant Flow
Pregnant women were recruited when attending routine antenatal care through referral to study staff. Those interested were asked to provide verbal consent for screening to assess eligibility, and if eligible, they were invited to participate in the study. Women were followed until 6 weeks postpartum but their infants were not considered enrolled. Infant outcomes were obtained from the participants and considered participant outcomes.
Participant milestones
| Measure |
Interactive Two-way Text Messaging Dialogue
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
Control receiving standard of care.
|
|---|---|---|
|
Completed 6-week Follow-up
STARTED
|
2509
|
2511
|
|
Completed 6-week Follow-up
COMPLETED
|
2471
|
2470
|
|
Completed 6-week Follow-up
NOT COMPLETED
|
38
|
41
|
|
Included in Intention to Treat Analysis
STARTED
|
2509
|
2511
|
|
Included in Intention to Treat Analysis
COMPLETED
|
2442
|
2442
|
|
Included in Intention to Treat Analysis
NOT COMPLETED
|
67
|
69
|
Reasons for withdrawal
| Measure |
Interactive Two-way Text Messaging Dialogue
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
Control receiving standard of care.
|
|---|---|---|
|
Completed 6-week Follow-up
Withdrawal by Subject
|
6
|
3
|
|
Completed 6-week Follow-up
Death
|
2
|
1
|
|
Completed 6-week Follow-up
Lost to Follow-up
|
26
|
33
|
|
Completed 6-week Follow-up
Ineligible
|
4
|
3
|
|
Completed 6-week Follow-up
Partner refusal
|
0
|
1
|
|
Included in Intention to Treat Analysis
Ineligible for inclusion in analysis
|
67
|
69
|
Baseline Characteristics
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
Baseline characteristics by cohort
| Measure |
Interactive Two-way SMS Dialogue
n=2505 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2508 Participants
Control receiving standard of care.
|
Total
n=5013 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=39 Participants
|
25 years
n=41 Participants
|
25 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
2505 Participants
n=39 Participants
|
2508 Participants
n=41 Participants
|
5013 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2505 Participants
n=39 Participants
|
2508 Participants
n=41 Participants
|
5013 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Kenya
|
2505 participants
n=39 Participants
|
2508 participants
n=41 Participants
|
5013 participants
n=35 Participants
|
|
<12 years of education
|
1037 Participants
n=39 Participants
|
1005 Participants
n=41 Participants
|
2042 Participants
n=35 Participants
|
|
Household crowding (>3 people per room)
|
399 Participants
n=39 Participants
|
371 Participants
n=41 Participants
|
770 Participants
n=35 Participants
|
|
Married/cohabitating
|
2000 Participants
n=39 Participants
|
2050 Participants
n=41 Participants
|
4050 Participants
n=35 Participants
|
|
Employed
|
943 Participants
n=39 Participants
|
921 Participants
n=41 Participants
|
1864 Participants
n=35 Participants
|
|
Shares mobile phone
|
299 Participants
n=39 Participants
|
240 Participants
n=41 Participants
|
539 Participants
n=35 Participants
|
|
Can read SMS unassisted
|
2500 Participants
n=39 Participants
|
2501 Participants
n=41 Participants
|
5001 Participants
n=35 Participants
|
|
Can write SMS unassisted
|
2492 Participants
n=39 Participants
|
2501 Participants
n=41 Participants
|
4993 Participants
n=35 Participants
|
|
Received health SMS messages from another program
|
635 Participants
n=39 Participants
|
577 Participants
n=41 Participants
|
1212 Participants
n=35 Participants
|
|
Intimate partner violence in last month
|
91 Participants
n=39 Participants
|
98 Participants
n=41 Participants
|
189 Participants
n=35 Participants
|
|
Primigravida
|
864 Participants
n=39 Participants
|
828 Participants
n=41 Participants
|
1692 Participants
n=35 Participants
|
|
Twins
|
42 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Estimated gestational age in weeks at baseline
|
31.6 weeks
n=39 Participants
|
31.4 weeks
n=41 Participants
|
31.6 weeks
n=35 Participants
|
|
HIV positive
|
218 Participants
n=39 Participants
|
208 Participants
n=41 Participants
|
426 Participants
n=35 Participants
|
|
Elevated depressive symptoms defined as a score ≥13 on Edinburgh Postnatal Depression Score (EPDS)
|
78 Participants
n=39 Participants
|
81 Participants
n=41 Participants
|
159 Participants
n=35 Participants
|
|
Self-reported social support score using the MOS social support survey
|
80.3 units on a scale from 0-100
n=39 Participants
|
82.9 units on a scale from 0-100
n=41 Participants
|
81.6 units on a scale from 0-100
n=35 Participants
|
|
Parenting self-efficacy using the Karitane Parenting Confidence Scale (KPCS)
|
45 units on a scale from 0-45
n=39 Participants
|
45 units on a scale from 0-45
n=41 Participants
|
45 units on a scale from 0-45
n=35 Participants
|
|
Enrollment clinic
Facility 1
|
185 Participants
n=39 Participants
|
184 Participants
n=41 Participants
|
369 Participants
n=35 Participants
|
|
Enrollment clinic
Facility 2
|
480 Participants
n=39 Participants
|
481 Participants
n=41 Participants
|
961 Participants
n=35 Participants
|
|
Enrollment clinic
Facility 3
|
197 Participants
n=39 Participants
|
197 Participants
n=41 Participants
|
394 Participants
n=35 Participants
|
|
Enrollment clinic
Facility 4
|
766 Participants
n=39 Participants
|
772 Participants
n=41 Participants
|
1538 Participants
n=35 Participants
|
|
Enrollment clinic
Facility 5
|
458 Participants
n=39 Participants
|
459 Participants
n=41 Participants
|
917 Participants
n=35 Participants
|
|
Enrollment clinic
Facility 6
|
419 Participants
n=39 Participants
|
415 Participants
n=41 Participants
|
834 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 28 days postpartumPopulation: Intention-to-treat for participants with a known infant outcome at 6 weeks postpartum. Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth.
Death during 1st 28 days of life
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2442 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2442 Participants
Control receiving standard of care.
|
|---|---|---|
|
Neonatal Mortality
|
46 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 7 days postpartumPopulation: Intention-to-treat for participants with a known infant outcome at the 7th day of life. Seventy-two (72) stillbirths were removed from analysis cohort. This includes 13 participants for whom an outcome is not known at 6 weeks of life for the primary outcome. Seventy-two (72) stillbirths were removed from analysis cohort.Seventy-two (72) participants excluded from the Overall Number of Participants Analyzed, due to stillbirth.
Death during 1st 7 days of life
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2450 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2447 Participants
Control receiving standard of care.
|
|---|---|---|
|
Early Neonatal Mortality
|
38 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 1 hour postpartumPopulation: This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, who attended the 2 week follow-up visit, who did not decline to answer and those for whom data was not missing.
Number of participants initiating breastfeeding in 1st hour of life
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2088 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2007 Participants
Control receiving standard of care.
|
|---|---|---|
|
Initiation of Early Breastfeeding
|
1510 Participants
|
1402 Participants
|
SECONDARY outcome
Timeframe: 6-weeks postpartumPopulation: This population includes participants who did not experience a stillbirth or infant death by 6 weeks postpartum, who attended the 6 week follow-up visit, who did not decline to answer and those for whom data was not missing.
Exclusive breastfeeding at 6-week visit
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2386 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2396 Participants
Control receiving standard of care.
|
|---|---|---|
|
Exclusive Breastfeeding
|
2190 Participants
|
2217 Participants
|
SECONDARY outcome
Timeframe: 24 hours postpartumPopulation: This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, whose infants did not die on the first day of life, who did not decline to answer and those for whom data was not missing.
Number of participants not giving infant a bath in 1st 24 hours of life
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2332 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2343 Participants
Control receiving standard of care.
|
|---|---|---|
|
Thermal Care
|
2245 Participants
|
2232 Participants
|
SECONDARY outcome
Timeframe: 2-weeks postpartumPopulation: This population includes participants who did not experience a stillbirth or infant death by 2 weeks postpartum, those who did not decline to answer and those for whom data was not missing.
Number of participants with no application of substances to cord
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2374 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2378 Participants
Control receiving standard of care.
|
|---|---|---|
|
Cord Care
|
1123 Participants
|
1104 Participants
|
SECONDARY outcome
Timeframe: 14 days at home postpartumPopulation: Only among preterm and/or low birth weight live births.
Number of participants providing any duration of skin-to-skin care on ≥10 of the first 14 days at home, among low birthweight or preterm infants
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=185 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=174 Participants
Control receiving standard of care.
|
|---|---|---|
|
Home Provision of Kangaroo Mother Care
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 6-weeks postpartumPopulation: For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing. Data are missing for those experienced an infant loss by the 6-week visit.
Number of danger signs or symptoms successfully named
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2389 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2397 Participants
Control receiving standard of care.
|
|---|---|---|
|
Maternal Knowledge of Neonatal Danger Signs
|
3 Number of danger signs named
Interval 2.0 to 4.0
|
2 Number of danger signs named
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: 18 weeks postpartumPopulation: Only in infants with illness episodes with danger signs and/or where the infant was hospitalized irrespective of danger signs reported.
Proportion of illness episodes with danger signs in which the clinic was attended and/or where the infant was hospitalized irrespective of danger signs reported in 1st 18 weeks of life (study follow-up period).
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=214 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=172 Participants
Control receiving standard of care.
|
|---|---|---|
|
Appropriate Care-seeking
|
204 Participants
|
160 Participants
|
SECONDARY outcome
Timeframe: Enrollment through 6-weeks postpartumPopulation: This population includes participants who attended the 6 week visit, those who did not decline to answer and those for whom data was not missing.
Score above diagnostic threshold (\>=13) for Edinburgh Postnatal Depression Scale. Possible scores are 0-30, with a higher score indicating a higher likelihood of possible depressive illness.
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2467 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2462 Participants
Control receiving standard of care.
|
|---|---|---|
|
Elevated Depressive Symptoms
|
38 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Enrollment through 6-weeks postpartumPopulation: For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing.
Score using Medical Outcomes Study (MOS) Social Support Survey. Possible scores are 0-100, with a higher score indicating higher levels of social support.
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2469 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2466 Participants
Control receiving standard of care.
|
|---|---|---|
|
Social Support
|
84.2 score on a scale
Interval 69.7 to 100.0
|
84.2 score on a scale
Interval 68.4 to 100.0
|
SECONDARY outcome
Timeframe: Enrollment through 6-weeks postpartumPopulation: For this time-varying outcome, data for the 6-week visit are presented here. This population includes those who did not decline to answer and those for whom data was not missing.
Score using the Karitane Parenting Confidence Scale. Possible scores are 0-45, with higher scores indicating higher levels of parenting confidence.
Outcome measures
| Measure |
Interactive Two-way SMS Dialogue
n=2253 Participants
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2247 Participants
Control receiving standard of care.
|
|---|---|---|
|
Self-efficacy
|
45 score on a scale
Interval 43.0 to 45.0
|
45 score on a scale
Interval 43.0 to 45.0
|
Adverse Events
Interactive Two-way SMS Dialogue
Serious events: 171 serious events
Other events: 7 other events
Deaths: 2 deaths
No SMS Control
Serious events: 114 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Interactive Two-way SMS Dialogue
n=2505 participants at risk
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2508 participants at risk
Control receiving standard of care.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Maternal death
|
0.08%
2/2505 • Number of events 2 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
0.08%
2/2508 • Number of events 2 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
|
Pregnancy, puerperium and perinatal conditions
Infant death
|
2.2%
54/2441 • Number of events 55 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
1.6%
39/2442 • Number of events 40 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
1.4%
34/2505 • Number of events 34 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
1.6%
39/2508 • Number of events 39 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
|
General disorders
Maternal hospitalization
|
1.3%
33/2505 • Number of events 35 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
0.44%
11/2508 • Number of events 12 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
|
General disorders
Infant hospitalization
|
3.6%
90/2471 • Number of events 94 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
1.9%
46/2469 • Number of events 46 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
|
General disorders
Maternal disappearance
|
0.04%
1/2505 • Number of events 1 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
0.00%
0/2508 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
Other adverse events
| Measure |
Interactive Two-way SMS Dialogue
n=2505 participants at risk
Participants will receive automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Interactive two-way SMS dialogue: We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
|
No SMS Control
n=2508 participants at risk
Control receiving standard of care.
|
|---|---|---|
|
Social circumstances
Social harm
|
0.28%
7/2505 • Number of events 7 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
0.08%
2/2508 • Number of events 4 • Adverse events were collected during the entire span of the study from enrollment through the participants' study exit at 18 weeks postpartum.
Participants (i.e. mothers) were systematically assessed for events throughout their study enrollment; information provided was by their self-report. Adverse events include social harms, encompassing abuse, suicidal behavior, and psychological distress. Serious adverse events include infant hospitalization and death; stillbirth; maternal hospitalization, death, and disappearance.
|
Additional Information
Jennifer Unger, MD, MPH. Associate Professor, Department of Obstetrics and Gynecology
Women and Infants Hospital of Rhode Island
Phone: (401) 274-1122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place