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| Name | Class |
|---|---|
| American College of Obstetricians and Gynecologists | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm A | Active Comparator | Study Arm A is one of two interventions (Combined estrogen-progestin pill) |
|
| Study Arm B | Active Comparator | Study Arm B is one of two interventions (Progestin-only pill) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined estrogen-progestin pill | Drug | 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 8, Week 8, 2-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 8, Week 8, 2-6 months |
| Infant Length Growth From 2-8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eve Espey, MD | UNM OB Gyn | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22143258 | Derived | Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):5-13. doi: 10.1097/AOG.0b013e31823dc015. |
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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.
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:
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Estrogen-progestin Pill | Study Arm A is one of two interventions. |
| FG001 | Progestin-only Pill | Study Arm B is one of two interventions. |
| FG002 | Not Randomized | Participants who were consented but not randomized. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Estrogen-progestin Pill | Study Arm A is one of two interventions (OCP). |
| BG001 | Progestin-only Pill | Study Arm B is one of two interventions (POP). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participants available for follow-up through a 6 month period | Posted | Number | participants | Baseline to Week 8, Week 8, 2-6 months |
|
3 years - no adverse events reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Estrogin-progestin Pill | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eve Espey MD, MPH, Principal Investigator | University of New Mexico | 505 272 6372 | eespey@salud.unm.edu |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Progestin-only pill | Drug | .35 mg norethindrone once a day orally |
|
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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. |
| Week 2 and Week 8 |
| 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. | Week 2 and Week 8 |
| 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. | Week 2 and Week 8 |
| Not Randomized |
|
| BG002 | Not Randomized | 70 women who were enrolled. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Participants available for follow-up through a 6 month period | Posted | Number | participants | Baseline to Week 8, Week 8, 2-6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | cm | Week 2 and Week 8 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | kg | Week 2 and Week 8 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | cm | Week 2 and Week 8 |
|
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| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Progestin-only Pill | Study Arm B is one of two interventions (Progestin-only pill) Progestin-only pill: .35 mg norethindrone once a day orally | 0 | 63 | 0 | 63 |
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| Participants available for follow-up at 8 weeks |
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| Discontinued oral contraceptives from 2-6 months |
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| Participants available for follow-up at 6 months |
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