Trial Outcomes & Findings for Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial (NCT NCT01465022)
NCT ID: NCT01465022
Last Updated: 2016-05-20
Results Overview
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
COMPLETED
NA
197 participants
Baseline to Week 8, Week 8, 2-6 months
2016-05-20
Participant Flow
The study design is double-blind randomized controlled trial in which postpartum women who have decided to breastfeed and who choose birth control pills as their contraceptive method are randomized to one of two groups:
The research nurse recruiting the eligible subject will ask the subject if they have been given adequate time to make a decision regarding study participation.
Participant milestones
| Measure |
Combined Estrogen-progestin Pill
Study Arm A is one of two interventions.
|
Progestin-only Pill
Study Arm B is one of two interventions.
|
Not Randomized
Participants who were consented but not randomized.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
70
|
|
Overall Study
COMPLETED
|
41
|
40
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
70
|
Reasons for withdrawal
| Measure |
Combined Estrogen-progestin Pill
Study Arm A is one of two interventions.
|
Progestin-only Pill
Study Arm B is one of two interventions.
|
Not Randomized
Participants who were consented but not randomized.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
14
|
0
|
|
Overall Study
Breastfeeding discontinuation before 8 w
|
8
|
9
|
0
|
|
Overall Study
Not Randomized
|
0
|
0
|
70
|
Baseline Characteristics
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Baseline characteristics by cohort
| Measure |
Combined Estrogen-progestin Pill
n=64 Participants
Study Arm A is one of two interventions (OCP).
|
Progestin-only Pill
n=63 Participants
Study Arm B is one of two interventions (POP).
|
Not Randomized
n=70 Participants
70 women who were enrolled.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
197 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 4.4 • n=99 Participants
|
25.0 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
23.4 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
24.4 years
STANDARD_DEVIATION 197 • n=7 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
197 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
63 participants
n=107 Participants
|
70 participants
n=206 Participants
|
197 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8, Week 8, 2-6 monthsPopulation: Participants available for follow-up through a 6 month period
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
Outcome measures
| Measure |
Combined Estrogen-progestin Pill
n=64 Participants
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
|
Progestin-only Pill
n=63 Participants
Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally
|
|---|---|---|
|
Number of Participants Who Continued to Breastfeed at 6 Months
Particpants lost to follow-up
|
15 participants
|
14 participants
|
|
Number of Participants Who Continued to Breastfeed at 6 Months
Discontinued Breastfeeding prior to 8 weeks
|
8 participants
|
9 participants
|
|
Number of Participants Who Continued to Breastfeed at 6 Months
# of participants included in 8 week follow-up
|
41 participants
|
40 participants
|
|
Number of Participants Who Continued to Breastfeed at 6 Months
Discontinued breastfeeding between 2-6 months
|
13 participants
|
14 participants
|
|
Number of Participants Who Continued to Breastfeed at 6 Months
Participants available for follow-up at 6 months
|
28 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8, Week 8, 2-6 monthsPopulation: Participants available for follow-up through a 6 month period
Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery
Outcome measures
| Measure |
Combined Estrogen-progestin Pill
n=64 Participants
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
|
Progestin-only Pill
n=63 Participants
Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally
|
|---|---|---|
|
Number of Participants Who Continued Birth Control Method After 6 Months
Participants available for follow-up at 6 months
|
29 participants
|
30 participants
|
|
Number of Participants Who Continued Birth Control Method After 6 Months
Particpants lost to follow-up
|
15 participants
|
14 participants
|
|
Number of Participants Who Continued Birth Control Method After 6 Months
Discontinued oral contraceptives by 8 week mark
|
1 participants
|
0 participants
|
|
Number of Participants Who Continued Birth Control Method After 6 Months
Participants available for follow-up at 8 weeks
|
40 participants
|
40 participants
|
|
Number of Participants Who Continued Birth Control Method After 6 Months
Discontinued oral contraceptives from 2-6 months
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Week 2 and Week 8Population: At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm. At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm.
Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.
Outcome measures
| Measure |
Combined Estrogen-progestin Pill
n=64 Participants
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
|
Progestin-only Pill
n=63 Participants
Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally
|
|---|---|---|
|
Infant Length Growth From 2-8 Weeks
Mean Infant length at 2 weeks
|
51.5 cm
Standard Deviation .49
|
51.7 cm
Standard Deviation .49
|
|
Infant Length Growth From 2-8 Weeks
Mean Infant length at 8 weeks
|
56.8 cm
Standard Deviation .49
|
57 cm
Standard Deviation .49
|
SECONDARY outcome
Timeframe: Week 2 and Week 8Population: At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm. At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm.
Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.
Outcome measures
| Measure |
Combined Estrogen-progestin Pill
n=64 Participants
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
|
Progestin-only Pill
n=63 Participants
Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally
|
|---|---|---|
|
Infant Weight Growth From 2-8 Weeks
Mean Infant weight at 2 weeks
|
3.7 kg
Standard Deviation .36
|
3.7 kg
Standard Deviation .36
|
|
Infant Weight Growth From 2-8 Weeks
Mean infant weight at 8 weeks
|
5.08 kg
Standard Deviation .36
|
5.2 kg
Standard Deviation .36
|
SECONDARY outcome
Timeframe: Week 2 and Week 8Population: At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm. At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm.
Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.
Outcome measures
| Measure |
Combined Estrogen-progestin Pill
n=64 Participants
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
|
Progestin-only Pill
n=63 Participants
Study Arm B is one of two interventions (Progestin-only pill)
Progestin-only pill: .35 mg norethindrone once a day orally
|
|---|---|---|
|
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
Infant occipitofrontal circumference at 2 weeks
|
36 cm
Standard Deviation .84
|
36.1 cm
Standard Deviation .84
|
|
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
Infant occipitofrontal circumference at 8 weeks
|
39 cm
Standard Deviation .84
|
39 cm
Standard Deviation .84
|
Adverse Events
Combined Estrogin-progestin Pill
Progestin-only Pill
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eve Espey MD, MPH, Principal Investigator
University of New Mexico
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place