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Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

NCT00847587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2016-04-18

Study results available
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Summary

A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.

Conditions

  • Complications; Contraceptive
  • Female Lactation

Interventions

DRUG

Etonogestrel contraceptive implant

Implant insertion postpartum prior to hospital discharge

DRUG

Etonogestrel contraceptive implant

Standard insertion at 4-8 weeks postpartum

Sponsors & Collaborators

Principal Investigators

  • Shawn E Gurtcheff, MD · University of Utah

  • David K Turok, MD · University of Utah

  • Kirtly P Jones, MD · University of Utah

  • Patricia Murphy, DrPH · University of Utah

  • Sara E Simonsen, RN, BSN · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00847587 on ClinicalTrials.gov