NCT02866279

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

4.4 years

First QC Date

August 7, 2016

Results QC Date

July 12, 2022

Last Update Submit

October 31, 2022

Conditions

ContraceptionBreastfeedingPostpartum Contraception

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Vaginal Bleeding

    0-6 months postpartum

  • Satisfaction With Contraceptive Implant

    0-6 months postpartum

Study Arms (3)

Postplacental

EXPERIMENTAL

contraceptive implant placed within 30 minutes of placental delivery

Device: Etonogestrel Contraceptive Implant

Immediate Postpartum

EXPERIMENTAL

Contraceptive Implant placed 1-3 days postpartum

Device: Etonogestrel Contraceptive Implant

Delayed

ACTIVE COMPARATOR

Contraceptive Implant placed 6 or more weeks postpartum

Device: Etonogestrel Contraceptive Implant

Interventions

Etonogestrel Contraceptive ImplantDEVICE

Women will be randomized to the TIMING of implant placement

Also known as: Nexplanon
DelayedImmediate PostpartumPostplacental

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Live pregnancy of at least 24 weeks gestation
  • Intention to use a contraceptive implant postpartum
  • 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

You may not qualify if:

  • Not English or Spanish speaking
  • Allergy or Contraindication to contraceptive implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10034, United States

Location

Related Publications (2)

  • 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.

    PMID: 21508750BACKGROUND

  • Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

    PMID: 36302159DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Erika Levi
Organization
Montefiore Medical Center
elevi@montefiore.org
7184058200

Study Officials

  • Erika Levi, MD, MPH

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2016

First Posted

August 15, 2016

Study Start

November 1, 2016

Primary Completion

April 7, 2021

Study Completion

September 30, 2021

Last Updated

November 1, 2022

Results First Posted

November 1, 2022

Record last verified: 2022-10

Locations

US(1)