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Immediate vs. Delayed Postpartum Etonogestrel Implant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767285
First Posted: January 14, 2013
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  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: None (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: 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.


Secondary Outcome Measures:
  • Rate of Intercourse [ Time Frame: 6 weeks ]
    To identify differences in the rates of intercourse prior to the 6-week postpartum visit.

  • 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.


Other Outcome Measures:
  • 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.

  • Pregnancy Rate [ Time Frame: 12 months ]
    To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.

  • 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.


Enrollment: 60
Study Start Date: January 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes 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.

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 7, 2013
First Posted: January 14, 2013
Results First Submitted: March 30, 2016
Results First Posted: December 19, 2016
Last Update Posted: February 28, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Etonogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists