Breast Feeding, Contraception
Conditions
Keywords
Breastfeeding rates, Contraceptive continuation, Birth control pills, Lactation
Brief summary
Objectives To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions: 1. To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills. 2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. 3. To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills. Hypothesis Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.
Interventions
DRUGCombined estrogen-progestin pill
1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
DRUGProgestin-only pill
.35 mg norethindrone once a day orally
Sponsors
American College of Obstetricians and Gynecologists
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* able to give informed consent * postpartum women delivering at the University of New Mexico Hospital * Intend to breastfeed * Plan to use oral contraceptives as her family planning method * Willing to be randomized to either progestin-only pills or combined pills
Exclusion criteria
* medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches * preterm birth (\<37 weeks) * small for gestational age infant (\<2500 grams) * large for gestational age infant (\>4500 grams) * infant with major congenital anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Continued to Breastfeed at 6 Months | Baseline to Week 8, Week 8, 2-6 months | Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Continued Birth Control Method After 6 Months | Baseline to Week 8, Week 8, 2-6 months | Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery |
| Infant Length Growth From 2-8 Weeks | Week 2 and Week 8 | 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. |
| Infant Weight Growth From 2-8 Weeks | Week 2 and Week 8 | 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. |
| Infant Occipitofrontal Circumference Growth From 2-8 Weeks | Week 2 and Week 8 | 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. |
Participant flow
Recruitment details
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:
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Combined Estrogen-progestin Pill Study Arm A is one of two interventions (OCP). | 64 |
| Progestin-only Pill Study Arm B is one of two interventions (POP). | 63 |
| Not Randomized 70 women who were enrolled. | 70 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Breastfeeding discontinuation before 8 w | 8 | 9 | 0 |
| Overall Study | Lost to Follow-up | 15 | 14 | 0 |
| Overall Study | Not Randomized | 0 | 0 | 70 |
Baseline characteristics
| Characteristic | Progestin-only Pill | Not Randomized | Combined Estrogen-progestin Pill | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 70 Participants | 64 Participants | 197 Participants |
| Age, Continuous | 25.0 years STANDARD_DEVIATION 5.4 | 23.4 years STANDARD_DEVIATION 5 | 23.8 years STANDARD_DEVIATION 4.4 | 24.4 years STANDARD_DEVIATION 197 |
| Region of Enrollment United States | 63 participants | 70 participants | 64 participants | 197 participants |
| Sex: Female, Male Female | 63 Participants | 70 Participants | 64 Participants | 197 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 63 |
Outcome results
Primary
Number of Participants Who Continued to Breastfeed at 6 Months
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
Time frame: Baseline to Week 8, Week 8, 2-6 months
Population: Participants available for follow-up through a 6 month period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined Estrogen-progestin Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Discontinued Breastfeeding prior to 8 weeks | 8 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Discontinued breastfeeding between 2-6 months | 13 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Particpants lost to follow-up | 15 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Participants available for follow-up at 6 months | 28 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued to Breastfeed at 6 Months | # of participants included in 8 week follow-up | 41 participants |
| Progestin-only Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Participants available for follow-up at 6 months | 26 participants |
| Progestin-only Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Discontinued Breastfeeding prior to 8 weeks | 9 participants |
| Progestin-only Pill | Number of Participants Who Continued to Breastfeed at 6 Months | # of participants included in 8 week follow-up | 40 participants |
| Progestin-only Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Discontinued breastfeeding between 2-6 months | 14 participants |
| Progestin-only Pill | Number of Participants Who Continued to Breastfeed at 6 Months | Particpants lost to follow-up | 14 participants |
Secondary
Infant Length Growth From 2-8 Weeks
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.
Time frame: Week 2 and Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Estrogen-progestin Pill | Infant Length Growth From 2-8 Weeks | Mean Infant length at 2 weeks | 51.5 cm | Standard Deviation 0.49 |
| Combined Estrogen-progestin Pill | Infant Length Growth From 2-8 Weeks | Mean Infant length at 8 weeks | 56.8 cm | Standard Deviation 0.49 |
| Progestin-only Pill | Infant Length Growth From 2-8 Weeks | Mean Infant length at 2 weeks | 51.7 cm | Standard Deviation 0.49 |
| Progestin-only Pill | Infant Length Growth From 2-8 Weeks | Mean Infant length at 8 weeks | 57 cm | Standard Deviation 0.49 |
Secondary
Infant Occipitofrontal Circumference Growth From 2-8 Weeks
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.
Time frame: Week 2 and Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Estrogen-progestin Pill | Infant Occipitofrontal Circumference Growth From 2-8 Weeks | Infant occipitofrontal circumference at 2 weeks | 36 cm | Standard Deviation 0.84 |
| Combined Estrogen-progestin Pill | Infant Occipitofrontal Circumference Growth From 2-8 Weeks | Infant occipitofrontal circumference at 8 weeks | 39 cm | Standard Deviation 0.84 |
| Progestin-only Pill | Infant Occipitofrontal Circumference Growth From 2-8 Weeks | Infant occipitofrontal circumference at 2 weeks | 36.1 cm | Standard Deviation 0.84 |
| Progestin-only Pill | Infant Occipitofrontal Circumference Growth From 2-8 Weeks | Infant occipitofrontal circumference at 8 weeks | 39 cm | Standard Deviation 0.84 |
Secondary
Infant Weight Growth From 2-8 Weeks
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.
Time frame: Week 2 and Week 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combined Estrogen-progestin Pill | Infant Weight Growth From 2-8 Weeks | Mean Infant weight at 2 weeks | 3.7 kg | Standard Deviation 0.36 |
| Combined Estrogen-progestin Pill | Infant Weight Growth From 2-8 Weeks | Mean infant weight at 8 weeks | 5.08 kg | Standard Deviation 0.36 |
| Progestin-only Pill | Infant Weight Growth From 2-8 Weeks | Mean Infant weight at 2 weeks | 3.7 kg | Standard Deviation 0.36 |
| Progestin-only Pill | Infant Weight Growth From 2-8 Weeks | Mean infant weight at 8 weeks | 5.2 kg | Standard Deviation 0.36 |
Secondary
Number of Participants Who Continued Birth Control Method After 6 Months
Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery
Time frame: Baseline to Week 8, Week 8, 2-6 months
Population: Participants available for follow-up through a 6 month period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combined Estrogen-progestin Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Particpants lost to follow-up | 15 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Discontinued oral contraceptives by 8 week mark | 1 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Participants available for follow-up at 8 weeks | 40 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Discontinued oral contraceptives from 2-6 months | 11 participants |
| Combined Estrogen-progestin Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Participants available for follow-up at 6 months | 29 participants |
| Progestin-only Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Participants available for follow-up at 6 months | 30 participants |
| Progestin-only Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Discontinued oral contraceptives from 2-6 months | 10 participants |
| Progestin-only Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Discontinued oral contraceptives by 8 week mark | 0 participants |
| Progestin-only Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Particpants lost to follow-up | 14 participants |
| Progestin-only Pill | Number of Participants Who Continued Birth Control Method After 6 Months | Participants available for follow-up at 8 weeks | 40 participants |