Ultrasound Surveillance of IUDs Placed Immediately Postpartum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- IUD-endometrial distance association with expulsion risk
研究概览
简要总结
Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception, and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy. IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal or cesarean birth. This practice has been shown to be safe, and is recommended by the American College of Obstetricians & Gynecologists, the World Health Organization and the U.S. Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing contraception at a time that the woman is already accessing medical care, avoiding potential loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia for delivery have reduced pain at the time of IUD placement compared to having the IUD placed at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively new practice in the US and little is known about the expected appearance of IUDs inside the uterus taken with an ultrasound when they have been placed at the time of delivery. It is less likely that IUD strings will be visible at the cervix after immediate postpartum IUD placement due to subsequent uterine involution, which makes it important to monitor correct positioning of the IUD via ultrasound. This study will document normal changes in the positioning of the IUD visualized via ultrasound, and determine if a correlation exists between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after placement. Symptoms of menstrual bleeding and pain will also be recorded in order to determine if they are correlated with IUD position.
详细描述
The goal of this study is to document the expected ultrasound appearance of intrauterine devices (IUDs) placed immediately postpartum. This practice has been shown to be safe and effective, but little is known about long-term follow up for IUDs placed in this setting. Because IUD strings will not be visualized for many patients after immediate postpartum IUD placement, sonographic imaging will likely be required for the majority of patients to determine expulsion. However, the ultrasound appearance of these IUDs, placed immediately after birth and before uterine involution, may be different than those IUDs placed outside of the postpartum period. To our knowledge no other study has documented expected ultrasound appearance of IUDs placed in the immediate postpartum period.
The specific aims of this study are to: 1. document normal appearance of IUDs on ultrasound after immediate postpartum placement; 2. document if this appearance changes over time; and 3. determine if location on ultrasound is associated with side effects or expulsion.
Study design This is a prospective, observational study. All patients who have an IUD (either copper or levonorgestrel) placed immediately postpartum (within 10 minutes of delivery of placenta) after either Cesarean or vaginal delivery at Mount Sinai Medical Center and at Elmhurst Hospital Center will be eligible to participate in the study.
Study visits will include a speculum exam for IUD string check at 6 weeks, and ultrasounds to evaluate IUD position at the following time points: 6-10 weeks following placement, 3 months following placement (with inclusion up to 6 months), and 12 months following placement (with inclusion up to 15 months).
The ultrasound will document the following: size and position of uterus, IUD-Myometrium distance, IUD-endometrium distance, IUD-fundus distance and position of IUD. When participants present for the scheduled ultrasound visits, they will be asked to return with the completed symptom diary as well, to assess bleeding and pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women >18 years of age
- •English or Spanish speaking
- •Desire postpartum IUD placement, either copper IUD or levonorgestrel IUD
排除标准
- •Contraindications for IUD use (CDC MEDICAL Eligibility Criteria category 3 or 4 for specific IUD)
- •Positive Chlamydia or gonorrhea cervical cultures in past 3 months
- •Immediate postpartum hemorrhage
- •Premature rupture of membranes (PROM) >12h or diagnosis of endometritis
结局指标
主要结局
IUD-endometrial distance association with expulsion risk
时间窗: at 1 year after IUD placement
次要结局
- Expected normal appearance of IUD on ultrasound and change in appearance over time(1 year after IUD placement)
- IUD endometrial distance association with side effects(1 year after IUD placement)