N/A
N=155
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Contraception · Breastfeeding · Postpartum Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02866279 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants Breastfeeding at 6 Months — 6; 4; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Etonogestrel Contraceptive Implant (Device)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- Female
- Sponsor
- Montefiore Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Breastfeeding at 6 Months |
6; 4; 6 | — |
| PRIMARY Time to Lactogenesis Stage II |
66.9; 62.1; 57.3 | — |
| SECONDARY Vaginal Bleeding |
7; 6; 4 | — |
| SECONDARY Satisfaction With Contraceptive Implant |
8.41; 8.14; 8.69 | — |
Summary
The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period
Eligibility Criteria
Inclusion Criteria
- Live pregnancy of at least 24 weeks gestation
- Intention to use a contraceptive implant postpartum
- 17 years of age or older
- English or Spanish speaking
- Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)
- The presence of at least one of the following conditions known to be a risk factor for low milk supply:
- Expected delivery prior to 34 weeks
- Obesity (pre-pregnancy BMI >35)
- Polycystic Ovarian Syndrome
- Diabetes (gestational or pre-gestational)
- Self-reported difficulty with low milk supply in past
Exclusion Criteria
- Not English or Spanish speaking
- Allergy or Contraindication to contraceptive implant
Data sourced from ClinicalTrials.gov (NCT02866279). 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.