Immediate vs. Delayed Postpartum Etonogestrel Implant

January 13, 2017 updated by: Duke University

A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study

The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1)Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number 4)No contraindications to receiving this method of contraception, which include: known or suspected pregnancy, active liver disease or hepatic tumor, current or past history of thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or suspected breast cancer or history of breast cancer, hypersensitivity to any of the components of the device.

-

Exclusion Criteria:

  1. Not meeting inclusion criteria
  2. Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:

1. Non-nucleoside reverse transcriptase inhibitors 2. ritonavir-boosted protease inhibitors 3. Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine 4. Rifampin 5. St. John's Wort

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Postpartum Etonogestrel Implant
Etonogestrel implant placed in the hospital after delivery, before discharge home.
Drug: Etonogestrel implant
This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Other Names:
  • Nexplanon
  • Implanon
Active Comparator: Delayed postpartum etonogestrel implant
These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Drug: Etonogestrel implant
This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Other Names:
  • Nexplanon
  • Implanon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuation Rate
Time Frame: 1 year
To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Intercourse
Time Frame: 6 weeks
To identify differences in the rates of intercourse prior to the 6-week postpartum visit.
6 weeks
Continuation Rate
Time Frame: 6 months
To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuation of Breastfeeding
Time Frame: 6 months
To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
6 months
Pregnancy Rate
Time Frame: 12 months
To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
12 months
Patient Satisfaction
Time Frame: 12 months
To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Jessica Morse, MD, Duke Hospital Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 14, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00030001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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