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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866279
• Other study ID #: 2016-6852
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breastfeeding
• Contraception
• Postpartum Contraception

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