A Pilot Study of Early Postpartum Intrauterine Contraception
Condition: Unplanned Pregnancy
Intervention: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
Intervention description: Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: levonorgestrel releasing intrauterine device; levonorgestrel releasing intrauterine contraception; unintended pregnancy prevention; postpartum contraception

Summary:

      This is a prospective clinical trial of ultrasound guided intrauterine contraception
      insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month
      follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.

      The objective of this study is to measure intrauterine device (IUD) expulsion and the
      feasibility of conducting a future clinical trial to evaluate placement of the
      levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently pregnant with a single gestation of at least 27 completed weeks estimated
             gestational age, with no complications of pregnancy including, but not limited to,
             preeclampsia, non-gestational diabetes, anemia.

          -  Desires to use intrauterine contraception (IUD) after delivery

          -  Anticipates having a vaginal delivery

          -  No intention to leave the area 7 months after enrollment

          -  Able to consent to participate in the study in English

          -  Has no known uterine anomalies

          -  Has no allergies to any components of the intrauterine contraception

        Exclusion Criteria:

          -  Prior cesarean delivery

          -  Having been treated for pelvic inflammatory disease within 3 months prior to the start
             of the pregnancy

          -  Allergic to betadine

          -  Allergy to lidocaine

          -  Medical or personal conditions which in the judgment of study staff contradict
             participation in the study

          -  Any contraindications to use of the levonorgestrel-releasing intrauterine
             contraceptive system which includes: known or suspected breast carcinoma, acute liver
             disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in
             situ

          -  After enrollment, and after delivery of the infant but before IUD insertion subjects
             will be excluded by checking with the attending obstetric physician and/or obstetric
             medical chart for the following:

               -  Endometritis or chorioamnionitis during the intrapartum period

               -  Membranes ruptured for greater than 24 hours prior to delivery

               -  Fever greater than or equal to 38C

               -  The need to use additional medications other than pitocin and/or misoprostol to
                  control postpartum bleeding