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

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Postpartum Contraception; Contraception; Breastfeeding

Treatments: Device: Etonogestrel Contraceptive Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02866279

2016-6852

Details and patient eligibility

About

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

Full 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.

Enrollment: 155 patients

Sex: Female

Ages: 17 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Postplacental

Experimental group

Description:

contraceptive implant placed within 30 minutes of placental delivery

Treatment:

Device: Etonogestrel Contraceptive Implant

Immediate Postpartum

Experimental group

Description:

Contraceptive Implant placed 1-3 days postpartum

Treatment:

Device: Etonogestrel Contraceptive Implant

Delayed

Active Comparator group

Description:

Contraceptive Implant placed 6 or more weeks postpartum

Treatment:

Device: Etonogestrel Contraceptive Implant