Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study
Condition: Postpartum Period
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The purpose of the study is to determine the feasibility of placing the
      levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The
      investigators will gain information about complications at the time of placement; the
      investigators will also examine the expulsion rate, side effects, bleeding patterns and
      subject satisfaction at various time periods after insertion.
    

Detailed description: 
      This trial is a prospective two-arm cohort study to examine feasibility, complications, and
      patient satisfaction related to postpartum IUD placement, to be conducted at Baystate Medical
      Center (BMC).

      There are two groups in this study. The first group is women who choose to have an IUD placed
      after delivery at BMC (IUD arm). The second group is women who decline an IUD but who will
      complete bleeding diaries for six-months postpartum (diary arm). We chose the LNG-IUS due to
      its high patient satisfaction rates and variety of non-contraceptive benefits.

      The standard of care for postpartum contraception is to provide women with information about
      her choices during her pregnancy, and to provide her with a method at hospital discharge
      after delivery. We will approach women at their routine prenatal visits. Women will be
      counseled by their provider about the risks, benefits and alternatives of all of the
      available methods of birth control (pills, patch, ring, injection, implant, IUD and
      sterilization). We will provide written information about her choices. We will discuss in
      detail the issues surrounding postpartum IUD placement, which most women will not be familiar
      with as an option, and provide a detailed information sheet for her to take home. We will
      revisit the issue of contraception at each subsequent visit until the patient has made a
      decision about what method she wishes to use.

      IUD ARM

      All women who request postpartum IUD placement will be offered enrollment in the study in the
      IUD arm. If a patient wishes to enroll, we will obtain written informed consent for the study
      and the LNG-IUS. We will administer a brief demographic and contraceptive history
      questionnaire. Subjects will be given a prescription for the LNG-IUS to bring with them to
      the hospital at the time of their delivery. A notation about study involvement will be made
      in the problem list of the subject's electronic prenatal record, and she will be reminded by
      her provider at each subsequent visit to bring the IUD when she comes to the hospital for
      delivery.

      The Mirena IUS (Bayer Pharmaceuticals) is a sterile, levonorgestrel-releasing (20 mcg/day)
      intrauterine system indicated for intrauterine contraception for up to 5 years. The local
      mechanism by which continuously released levonorgestrel enhances contraceptive effectiveness
      of Mirena has not been conclusively demonstrated. Studies of Mirena prototypes have suggested
      several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of
      sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the
      endometrium.

      All LNG-IUS insertions will be performed by the PI or by 2nd year obstetrics and gynecology
      residents. These residents all have experience with traditional IUD insertions, and they will
      be trained by the PI in postpartum IUD insertion. Training will involve a short lecture,
      practice insertions on a pelvic model, then observing a postpartum insertion by the PI.
      Insertions will be performed at one of three times:

        1. at the time of vaginal delivery, within 10 minutes of placental delivery (immediate
           placement);

        2. at the time of cesarean delivery, within 10 minutes of placental delivery (immediate
           placement);

        3. within 48 hours of either vaginal delivery or cesarean delivery (delayed placement).

      At the time of vaginal delivery, the LNG-IUS will be inserted guided by trans-abdominal
      ultrasound to help ensure placement as close to the fundus as possible. If ultrasound is
      unavailable, another attempt at IUD placement will be made when the ultrasound becomes
      available.

      At the time of cesarean delivery, the LNG-IUS will be placed prior to closure of the uterine
      incision.

      At the time of delayed placement, subjects will be offered a dose of their routine postpartum
      pain medication (ibuprofen or oxycodone) prior to insertion. The LNG-IUS will be inserted
      guided by trans-abdominal ultrasound to help ensure placement as close to the fundus as
      possible. If ultrasound is unavailable, another attempt at IUD placement will be made when
      the ultrasound becomes available.

      If a subject has not filled the prescription for the IUD by the time of delivery, we will
      submit an electronic prescription to the hospital pharmacy for the IUD, and the IUD may be
      picked up by a family member or friend and brought to L&D for placement. If a subject has
      left the IUD at home when she comes into the hospital for delivery, the IUD may be brought
      into the hospital by a family member or friend; if the IUD arrives at the hospital after
      delivery, she will be scheduled for a delayed postpartum placement. If the subject has been
      unable to obtain the IUD by 48 hours after delivery, she will be offered interval placement
      at the time of her postpartum visit.

      All subjects will receive a bleeding diary to complete at home. We will call subjects at two
      weeks postpartum. During this telephone call we will ask questions regarding short term
      complications such as bleeding and signs of infection. If the subject has seen a medical
      professional before this phone call, or the LNG-IUS was expelled or removed, specific
      questions will be asked regarding these circumstances. At their six week postpartum visit,
      subjects will review their bleeding diary with study staff, complete a questionnaire and be
      evaluated for intrauterine IUD placement. If the tail strings are not visible a trans-vaginal
      ultrasound will be performed to assess placement. An intra-cervical LNG-IUS will be
      considered an expulsion and removal will be performed. Subjects will be counseled to return
      to clinic if they suspect expulsion at any time. We will provide stamped envelopes for
      subjects to mail back their bleeding diary at 12 weeks postpartum. We will call subjects at
      12 weeks and six months postpartum regarding complications and specific questions about their
      satisfaction with the LNG-IUS.

      DIARY-ONLY ARM

      Women who do not want a postpartum IUD but who are interested in study participation will be
      offered enrollment in the diary-only arm. If a patient wishes to enroll, we will obtain
      written informed consent for the study and we will administer a brief demographic and
      contraceptive history questionnaire. Subjects will be given the bleeding diary to start after
      their discharge from the hospital after delivery. We will provide stamped envelopes for
      subjects to mail back their bleeding diary at 12 weeks postpartum.
    

Intervention name(s): IUD; Diary
Intervention type(s): Device; Other
Intervention description(s): Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.; Subjects will keep a bleeding diary for three months
Other intervention name(s): Mirena intrauterine system; bleeding diary (three-month calendar)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intrauterine device; Mirena; levonorgestrel intrauterine system; postpartum contraception