Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

Conditions
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Contraception, Breastfeeding, Postpartum Contraception

Intervention / Treatment
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* Device: Etonogestrel Contraceptive Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postplacental<br>contraceptive implant placed within 30 minutes of placental delivery | Device: Etonogestrel Contraceptive Implant<br>* Women will be randomized to the TIMING of implant placement<br>* Other names: Nexplanon;|
| Experimental: Immediate Postpartum<br>Contraceptive Implant placed 1-3 days postpartum | Device: Etonogestrel Contraceptive Implant<br>* Women will be randomized to the TIMING of implant placement<br>* Other names: Nexplanon;|
| Active Comparator: Delayed<br>Contraceptive Implant placed 6 or more weeks postpartum | Device: Etonogestrel Contraceptive Implant<br>* Women will be randomized to the TIMING of implant placement<br>* Other names: Nexplanon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Breastfeeding at 6 Months | Exclusive Breastfeeding at 6 months | 6 months postpartum | 
| Time to Lactogenesis Stage II | Difference in time to Lactogenesis Stage II | 1-5 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Bleeding | Number of Participants that reported heavy bleeding at 6 months postpartum | 0-6 months postpartum | 
| Satisfaction With Contraceptive Implant | Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum | 0-6 months postpartum |