Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

NCT00847587 | Completed Phase 4 Results DMC

• 1 other identifier: 30291
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Contraceptive; Implant; Postpartum period; etonogestrel-releasing; lactogenesis; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Time to Lactogenesis Stage II

  The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, "Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby's mouth, or gulping by the baby. " If the response was positive, subjects were then asked, "When did your milk come in?" and the response recorded to the nearest hour.

  5 days postpartum

Secondary Outcomes (1)

• Crematocrit of Human Milk

  6 weeks postpartum

Study Arms (2)

1

EXPERIMENTAL

Early postpartum insertion

Drug: Etonogestrel contraceptive implant

2

ACTIVE COMPARATOR

Standard postpartum insertion

Drug: Etonogestrel contraceptive implant

Interventions

Etonogestrel contraceptive implant DRUG

Implant insertion postpartum prior to hospital discharge

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy,
• years old,
• delivered a healthy term infant,
• intend to breastfeed,
• desire Implanon as their method of contraception, and
• agree to be randomized to early versus standard postpartum insertion.

You may not qualify if:

• obstetric complications including anemia with hematocrit\<30,
• transfusion,
• infection,
• severe pregnancy induced hypertension,
• prolonged hospitalization,
• coagulopathy,
• liver disease,
• undiagnosed genital bleeding,
• or other relative contraindication to Implanon® insertion (known or suspected pregnancy, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in Implanon®).
• Women taking drugs that are potent inducers of hepatic enzymes will also be excluded, including barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, modafinil, protease inhibitors, and herbal products including St. John's Wort.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84105, United States

Location

Related 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.

  PMID: 21508750 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

Limitations:Study was not blinded \& early insertion was allowed as late as 3 days postpartum. Insertion on postpartum days 1-3 was allowed so long as lactogenesis had not already occurred to mimic normal clinical practice \& improve generalizability.

Results Point of Contact

• Title: Kirtly Parker Jones
• Organization: UUtah

kirtly.jones@hsc.utah.edu

801-581-3834

Study Officials

• Shawn E Gurtcheff, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• David K Turok, MD

  University of Utah

  STUDY CHAIR

• Kirtly P Jones, MD

  University of Utah

  STUDY DIRECTOR

• Patricia Murphy, DrPH

  University of Utah

  STUDY DIRECTOR

• Sara E Simonsen, RN, BSN

  University of Utah

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: April 18, 2016
• Results First Posted: June 2, 2011

Record last verified: 2016-03

Locations

US (1)