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Completed

NCT Number: NCT02866279

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

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

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Key information

Age range

17 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10034, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etonogestrel Contraceptive Implant

Device

Women will be randomized to the TIMING of implant placement

Other names: Nexplanon

Primary outcomes

  1. Number of Participants Breastfeeding at 6 Months

    Time frame: 6 months postpartum

    Exclusive Breastfeeding at 6 months

  2. Time to Lactogenesis Stage II

    Time frame: 1-5 days postpartum

    Difference in time to Lactogenesis Stage II

Secondary outcomes

  1. Vaginal Bleeding

    Time frame: 0-6 months postpartum

    Number of Participants that reported heavy bleeding at 6 months postpartum

  2. Satisfaction With Contraceptive Implant

    Time frame: 0-6 months postpartum

    Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Society of Family Planning

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2016
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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