Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant
Condition: Complications; Contraceptive; Female Lactation
Study type: Interventional
Phase: Phase 4

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.
    

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 concealment will be assured by enclosing assignments in sequentially numbered,
      opaque, sealed envelopes. Envelopes will be opened sequentially and only after the
      participant's name and study number are written on the envelope. Follow-up and data
      collection for participants in each group will be identical. Outcome assessors and data
      analysts will be blinded to treatment arm.

      STUDY PROCEDURES:

      Inclusion/exclusion criteria will be verified and consent obtained. The patient will be
      notified of the results of randomization and the physician able to perform insertion will be
      contacted to perform the insertion. All insertions will be performed by physicians who have
      completed Implanon® insertion training. If the patient randomizes to standard postpartum
      insertion, she will be given a clinic appointment in 4-8 weeks for the insertion procedure.

      Lactogenesis time will be documented by maternal perception, as described and validated by
      Chapman et al16. If lactogenesis has not occurred prior to hospital discharge, the patient
      will receive daily phone calls from study personnel until lactogenesis can be confirmed and
      recorded. Contact information for the patient, as well as for two friends or relatives who
      will know how to reach her will be obtained and verified prior to discharge. Participants
      will be given a reminder card for the telephone calls from the investigator and a postpartum
      visit appointment. Patients will be instructed to contact the investigators immediately for
      pain, excessive bleeding, difficulty with breastfeeding, or other concerns. Patients will be
      given a log book ("diary") to record breastfeeding parameters including use of
      supplementation, infant weights, side effects, return to sexual intercourse, contraceptive
      method use, and days of bleeding for the study follow-up period.

      Clinical follow-up will be as follows. Postpartum telephone calls or visits to collect
      additional data will occur as needed for up to 5 days following hospital discharge, at 2
      weeks, 4-8 weeks, and 3 and 6 months postpartum. Information obtained at these points will
      include: breastfeeding status and parameters, collection of record of infant weights (birth,
      4-8 weeks, and 6 months), reminders to keep weekly diary, collection of diaries (6 month
      visit), resumption of sexual activity, use of contraceptive method, and satisfaction with
      contraceptive method. Patients randomized to early insertion will be asked to give a milk
      sample for analysis at their 4-8 week visit. Table 1 describes the contact points with the
      subject for collection of data. Contact will be either by telephone or at clinic visits.
    

Intervention name(s): Etonogestrel contraceptive implant; Etonogestrel contraceptive implant
Intervention type(s): Drug; Drug
Intervention description(s): Implant insertion postpartum prior to hospital discharge; Standard insertion at 4-8 weeks postpartum
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contraceptive; Implant; Postpartum period; etonogestrel-releasing; lactogenesis; Breastfeeding