Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents
Condition: Contraceptive Usage
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aim of this study is to evaluate whether insertion of a long-acting
      contraceptive implant in postpartum adolescents prior to hospital discharge increases use of
      this highly effective contraception during the first twelve months postpartum among
      adolescents who elect Implanon® as their preferred method of contraception. Additionally,
      this study aims to compare the acceptability of bleeding in postpartum adolescents who have
      an etonogestrel contraceptive implant prior to discharge versus those with insertion at the
      six week postpartum visit. The investigators will evaluate the acceptability of bleeding
      rather than collect prospective diaries because the investigators feel subjective perceptions
      of bleeding impact contraceptive continuation more than quantitative differences in bleeding.
    

Detailed description: 
      Study Design and Subject Recruitment The investigators propose a prospective randomized trial
      comparing immediate postpartum insertion of Implanon® versus insertion at the standard six
      week postpartum visit in adolescents. Recruitment will occur on our postpartum ward.

      The study coordinator will approach all eligible women on the postpartum ward to offer
      comprehensive contraceptive counseling including information about Implanon® as well as other
      methods. Those who choose Implanon® will be screened for eligibility and consented for
      participation in the study. If a subject is under 18 years of age, the investigators will
      obtain parental consent from at least one parent or legal guardian as well as assent from the
      adolescent participant according to our IRB guidelines. Those who are not interested in
      participation will be provided with a standard postpartum appointment for insertion. Based on
      our volume of adolescent deliveries, the investigators anticipate to complete enrollment
      within 1 year and follow-up within two years.

      Inclusion and Exclusion Criteria Women will be eligible for enrollment if they are 21 years
      old or younger, English or Spanish speaking, less than 120 hours (5 days) postpartum after
      either vaginal or cesarean delivery, primiparous or multiparous, and breast and/or
      bottle-feeding. Women will be excluded from enrollment if they have contraindications to
      Implanon® insertion including current or prior thrombo-embolic disease, liver disease,
      hypersensitivity to components of Implanon®, or are using medications such as rifampin,
      phenytoin, or carbamazepine that increase metabolism of steroid hormones. Women will also be
      excluded if they indicate unwillingness to continue follow-up for one year.

      Randomization After consent is obtained, each participant will be randomized to one of two
      groups. The study coordinator will open opaque sealed envelopes containing group assignment
      in sequence. The envelopes will be prepared by a research staff member not involved in
      recruitment or analysis prior to start of enrollment. The randomization scheme will utilize
      permuted blocks of sizes four and six. The intervention group will undergo Implanon®
      insertion prior to hospital discharge per package instructions. For those randomized to this
      group, the study coordinator will notify the physician on call to ensure insertion prior to
      discharge. This will not prolong hospital stay. The control group will receive an appointment
      to undergo Implanon® insertion at the postpartum visit occurring approximately six weeks
      after delivery as is standard care in our institution. In addition to standard counseling to
      avoid sexual intercourse for six weeks, all participants will be counseled about condom use
      for prevention of both sexually transmitted infections and pregnancy.

      Follow-up At the time of enrollment, each participant will complete a questionnaire to
      collect information about sociodemographic characteristics, sexual and reproductive history,
      contraceptive history, bleeding expectations, breast feeding intentions, and prior sexual
      education experiences. Each participant will be provided with a notice of study participation
      to give their provider at their postpartum follow-up visit but there will not be contact
      between study staff and participants at the six week postpartum visit. Each participant will
      be contacted by telephone at three, six, and twelve months postpartum. Follow-up
      questionnaires will be administered at this time to assess use of Implanon® since delivery,
      use of other highly effective and less effective contraceptive methods, the acceptability of
      bleeding experiences, and the prevalence and duration of breastfeeding.

      Outcomes

        -  Primary Outcome is the proportion of participants in each group using Implanon® at six
           months.

        -  Secondary Outcomes Contraceptive Use and Pregnancy

        -  Proportion of participants using Implanon at three months

        -  Proportion of participants using Implanon at twelve months

        -  Proportion of participants using another highly effective method at three, six, and
           twelve months.

      (Intrauterine contraception and sterilization will be considered highly effective in this
      study.)

        -  Proportion of participants using a less effective method at three, six, and twelve
           months. (DMPA, combined hormonal oral contraception, vaginal ring, transdermal patch,
           progestin only pills, and barrier methods will be considered less effective methods in
           this study.)

        -  Proportion of participants practicing abstinence at three, six, and twelve months.

        -  Proportion of participants using no contraceptive method at three, six, and twelve
           months.

        -  Reasons for non-use of Implanon at three, six, and twelve months.

        -  Reasons for non-use of any method at three, six, and twelve months.

        -  Pregnancy rate in each group at twelve months.

           o Bleeding Acceptability

        -  Bleeding expectations prior to insertion of Implanon

        -  Comparison of bleeding perceptions to pre-insertion expectations

        -  Proportion of participants who cite bleeding irregularities as a reason for non-use at
           three, six, and twelve months

        -  Satisfaction with bleeding on Likert scale

           o Overall Acceptability 5 of 12

        -  Proportion at three, six, and twelve months willing to use Implanon again after another
           delivery

        -  Proportion at three, six, and twelve months willing to recommend Implanon to a friend

           o Breast Feeding

        -  Proportion of participants in each group planning to breastfeed at time of enrollment

        -  Proportion of participants breast feeding at three, six, and twelve months

        -  Duration of breast feeding in weeks by participant report
    

Intervention name(s): Etonogestrel contraceptive implant
Intervention type(s): Drug
Intervention description(s): Etonogestrel contraceptive implant
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants were randomized to receive a contraceptive implant before hospital discharge or at their six week postpartum visit
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Implanon; Bleeding Acceptability; Contraceptive Implant; Adolescent Pregnancy Prevention; Post Partum Insertion of Implanon