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

Study Overview
=================
Brief 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: at the time of vaginal delivery, within 10 minutes of placental delivery (immediate placement); at the time of cesarean delivery, within 10 minutes of placental delivery (immediate placement); 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.

Official Title
-----------------
Bleeding Patterns and Complications After Postpartum Intrauterine Device (IUD) Placement: a Pilot Study

Conditions
-----------------
Postpartum Period

Intervention / Treatment
-----------------
* Device: IUD
* Other: Diary


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IUD Arm<br>Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth) | Device: IUD<br>* 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.<br>* Other names: Mirena intrauterine system;Other: Diary<br>* Subjects will keep a bleeding diary for three months<br>* Other names: bleeding diary (three-month calendar);|
| Other: Diary Arm<br>Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all | Other: Diary<br>* Subjects will keep a bleeding diary for three months<br>* Other names: bleeding diary (three-month calendar);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Patterns | Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum | 12 weeks post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsions | Incidence of spontaneous IUD expulsion in the six months after insertion | 6 months | 
| Satisfaction | Participant satisfaction with the IUD at 12 weeks post-insertion | 12 weeks post-partum | 
| Insertion Time | Time of insertion of the IUD | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intrauterine device, Mirena, levonorgestrel intrauterine system, postpartum contraception