Status:
COMPLETED
Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
Lead Sponsor:
University of Utah
Conditions:
Complications; Contraceptive
Female Lactation
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
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 rate...
Detailed Description
This is a randomized controlled trial. Participants will be assigned with equal probability to 1 of the 2 test groups using computer-generated random numbers in blocks of varying sizes. Allocation con...
Eligibility Criteria
Inclusion
- Patients on the postpartum ward at University Hospital will be offered inclusion in the study if they are:
- healthy,
- 18-40 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00847587
Start Date
January 1 2009
End Date
May 1 2010
Last Update
April 18 2016
Active Locations (1)
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1
University of Utah Hospital
Salt Lake City, Utah, United States, 84105