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

2016-08-16 10:08:21 | BioPortfolio


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


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 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention




Etonogestrel Contraceptive Implant


Montefiore Medical Center
New York
United States


Not yet recruiting


Montefiore Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2016-08-16T10:08:21-0400

Clinical Trials [1070 Associated Clinical Trials listed on BioPortfolio]

The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.

A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)

The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various...

Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents

The specific aim of this study is to evaluate whether insertion of a long-acting contraceptive implant in postpartum adolescents prior to hospital discharge increases use of this highly ef...

Effectiveness of Prolonged Use of IUD/Implant for Contraception

This study will evaluate LNG-IUD and ENG implant users who are willing to use their contraception beyond the end of the FDA-approved duration. Implant users will also be offered to partic...

A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702AM4)

The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include...

PubMed Articles [1312 Associated PubMed Articles listed on BioPortfolio]

Relationship between patient characteristics and serum etonogestrel concentrations in contraceptive implant users.

To determine whether serum etonogestrel concentrations in contraceptive implant users are associated with certain individual patient characteristics.

Assessing Weight Status in Adolescent and Young Adult Users of the Etonogestrel Contraceptive Implant.

There is inconsistent data regarding hormonal contraception and weight. Weight concerns may deter teens from using highly effective contraception such as the etonogestrel subdermal implant (ENG). Ther...

Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first two years of use?

To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the fi...

Influence of Genetic Variants on Steady-State Etonogestrel Concentrations Among Contraceptive Implant Users.

To identify genetic variants that influence steady-state etonogestrel concentrations among contraceptive implant users.

Effect of patient genetics on etonogestrel pharmacokinetics when combined with efavirenz or nevirapine ART.

We previously demonstrated that etonogestrel concentrations were 82% lower in women using etonogestrel contraceptive implants plus efavirenz-based ART compared with women not receiving ART.

Medical and Biotech [MESH] Definitions

Prevention of CONCEPTION by blocking fertility temporarily, or permanently (STERILIZATION, REPRODUCTIVE). Common means of reversible contraception include NATURAL FAMILY PLANNING METHODS; CONTRACEPTIVE AGENTS; or CONTRACEPTIVE DEVICES.

The rate of success or failure of a method of CONTRACEPTION; CONTRACEPTIVE AGENTS; or CONTRACEPTIVE DEVICES.

Contraceptive methods based on immunological processes and techniques, such as the use of CONTRACEPTIVE VACCINES.

Prevention of CONCEPTION by devices, chemical substances or agents with contraceptive activity in females which last for years and can be removed.

Methods of contraception in which physical, chemical, or biological means are used to prevent the SPERM from reaching the fertilizable OVUM.

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

Quick Search


Relevant Topics

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Obesity is the condition in which excess fat has accumulated in the body (mostly in subcutaneous tissues). clinical obesity is considered to be present when a person has a BMI of over 30 (Oxford Dictionary of Medicine). It is becoming increasing common i...

Searches Linking to this Trial