Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Treatments: Contraceptive Agents; Desogestrel; Etonogestrel

Criteria

Inclusion Criteria: 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 Criteria:

• 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.