Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
Condition: Complications; Contraceptive; Female Lactation
Intervention: Etonogestrel contraceptive implant; Etonogestrel contraceptive implant
Intervention description: Implant insertion postpartum prior to hospital discharge; Standard insertion at 4-8 weeks postpartum
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Desogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive; Implant; Postpartum period; etonogestrel-releasing; lactogenesis; Breastfeeding

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.
    

Eligibility 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.