Phase 4
N=30
Progestin-Only Pill Use and Breastfeeding Study
Contraception · Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT04965116 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. — 7; 7; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Progestin Only Contraceptive Pills (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. |
7; 7; 6 | — |
| SECONDARY Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum |
7; 8; 4 | — |
| SECONDARY Vaginal Bleeding |
0.1; 2.7; 0.2 | — |
| SECONDARY Satisfaction With Assigned POP |
6; 8; 5 | — |
| SECONDARY Protein Content of Human Milk |
1.49; 1.46; 1.26 | — |
| SECONDARY Carbohydrate Content of Human Milk |
9.11; 8.75; 9.25 | — |
| SECONDARY Fat Content of Human Milk |
3.79; 3.53; 3.24 | — |
| SECONDARY Perception of Milk Supply |
95.1; 96.5; 92.5 | — |
| SECONDARY Change in Infant Weight |
20.9; 28.4; 30.8 | — |
| SECONDARY Change in Infant Height |
7.2; 3.6; 6.8 | — |
| SECONDARY Change in Infant Head Circumference |
8.4; 7.3; 7.4 | — |
Summary
This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and older
- Desires to use POPs for 3 months
- Speak English or Spanish
- Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior
- Intends to breastfeed exclusively for 6 months
Exclusion Criteria
- Desire another pregnancy in less than 6 months
- Do not intend to exclusively breastfeed
- Do not have access to a telephone
- Have any medical contraindication to POPs
- Have any contraindication to breastfeeding, including maternal illegal drug use, history of augmentation or reduction, infant with major congenital anomaly
- Cognitively impaired
- Currently incarcerated
Data sourced from ClinicalTrials.gov (NCT04965116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.