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

Not Applicable

Completed

• Conditions: Contraception; Breastfeeding; Postpartum Contraception
• Interventions: Device: Etonogestrel Contraceptive Implant

• Registration Number: NCT02866279
• Lead Sponsor: Montefiore Medical Center

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-08-07
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2016-11
• Primary Completion: 2021-04-07
• Study Completion: 2021-09-30
• Results First Submitted: 2022-07-12
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Results First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postplacental	Etonogestrel Contraceptive Implant	contraceptive implant placed within 30 minutes of placental delivery
Immediate Postpartum	Etonogestrel Contraceptive Implant	Contraceptive Implant placed 1-3 days postpartum
Delayed	Etonogestrel Contraceptive Implant	Contraceptive Implant placed 6 or more weeks postpartum

Primary Outcome Measures

Name	Time	Method
Number of Participants Breastfeeding at 6 Months	6 months postpartum	Exclusive Breastfeeding at 6 months
Time to Lactogenesis Stage II	1-5 days postpartum	Difference in time to Lactogenesis Stage II

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States