Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study
Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study
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.
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.
Inclusion Criteria:

 -  age 18 years or older

 -  speak either English or Spanish

 -  desire to use an IUD as their postpartum contraception (IUD arm)

 -  do NOT desire an IUD as their contraception (Diary Only arm)

 -  plan to deliver at Baystate Medical Center.

 Exclusion Criteria:

 -  history of sexually transmitted infection during the three months prior to enrollment

 -  desiring of another pregnancy within six months of giving birth

 -  routine contraindications to IUD:

 -  cavity-distorting uterine fibroids or uterine anomalies

 -  known or suspected uterine or cervical neoplasia

 -  acute liver disease or liver tumor

 -  history of breast cancer