Contraception Clinical Trial
Official title:
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
Verified date | October 2022 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 155 |
Est. completion date | September 30, 2021 |
Est. primary completion date | April 7, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 17 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | Society of Family Planning |
United States,
Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet Gynecol. 2011 May;117(5):1114-1121. doi: 10.1097/AOG.0b013e3182165ee8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Breastfeeding at 6 Months | Exclusive Breastfeeding at 6 months | 6 months postpartum | |
Primary | Time to Lactogenesis Stage II | Difference in time to Lactogenesis Stage II | 1-5 days postpartum | |
Secondary | Vaginal Bleeding | Number of Participants that reported heavy bleeding at 6 months postpartum | 0-6 months postpartum | |
Secondary | Satisfaction With Contraceptive Implant | Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum | 0-6 months postpartum |
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