Immediate vs. Delayed Postpartum Etonogestrel Implant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01767285
First received: January 7, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Continuation Rate of Contraceptive Implant
Drug: Etonogestrel implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Continuation rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rate of intercourse [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To identify differences in the rates of intercourse prior to the 6-week postpartum visit.

  • Continuation Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Continuation Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Continuation of breastfeeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

  • Pregnancy Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

  • patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Implanon
  • Nexplanon
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:
  • Implanon
  • Nexplanon

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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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

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767285

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Jessica Morse, MD Duke Hospital Department of Obstetrics and Gynecology
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01767285     History of Changes
Other Study ID Numbers: Pro00030001
Study First Received: January 7, 2013
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Etonogestrel Implant
Implanon
Nexplanon
Long Acting Reversible Contraception

Additional relevant MeSH terms:
3-keto-desogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 24, 2014