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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02866279
Other study ID # 2016-6852
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date September 30, 2021

Study information

Verified date October 2022
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to have any adverse effects on lactogenesis or breastfeeding continuation. However, no high quality study to date has examined the effects of progestin-only contraception in women known to be at risk for low milk supply, including women with a premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of low milk supply. The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration. This will be a three-armed randomized non-inferiority study of women who plan to breastfeed, have known risk factors for low milk supply, and who intend to use the contraceptive implant postpartum. Women will be randomized to one of three groups for the timing of contraceptive implant placement: within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to Lactogenesis Stage II, duration and exclusivity of breastfeeding, continuation of and satisfaction with the contraceptive implant, and side effects, including bleeding patterns, associated with the implant. Findings from this trial will be used by clinicians, hospital systems, and policy makers working to expand access to immediate postpartum implants while supporting women in meeting their breastfeeding goals.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Etonogestrel Contraceptive Implant
Women will be randomized to the TIMING of implant placement

Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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