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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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Etonogestrel Contraceptive Implant
Montefiore Medical Center
Not yet recruiting
Montefiore Medical Center
Published on BioPortfolio: 2016-08-16T10:08:21-0400
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
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...
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...
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...
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...
To determine whether serum etonogestrel concentrations in contraceptive implant users are associated with certain individual patient characteristics.
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...
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...
To identify genetic variants that influence steady-state etonogestrel concentrations among contraceptive implant users.
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.
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.
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