Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Operative Time
研究概览
简要总结
Cervical preparation before second trimester dilation and evacuation (D&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D&E between 16+0 and 20+6 weeks gestation.
HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D&E performed between 16+0 and 20+6 weeks.
详细描述
Dilation and evacuation (D&E) is commonly performed for second trimester abortions and management of second trimester intrauterine fetal demise (IUFD). Cervical preparation prior to second trimester D&E increases safety.
Osmotic cervical dilators and prostaglandin analogs are used widely for cervical preparation before second trimester D&E. Osmotic dilators are placed into the cervical canal, radially expand as they absorb moisture and decrease the risk of cervical injury during D&E. Laminaria tents are the most commonly used osmotic dilator for D&E cervical preparation but require N18 h to reach maximum diameter. Dilapan-S®, a synthetic osmotic cervical dilator, has a significant dilation effect 2 h after placement with the majority of expansion occurring in 4-6 h according to the manufacturer.
Misoprostol is the most commonly used pharmacologic cervical preparation for D&E with duration of action between 2 and 4 h after administration. Multiple studies demonstrate the safety of misoprostol before early second trimester abortion. One prospective and four retrospective studies suggest that same-day cervical preparation with Dilapan-S and/or misoprostol for second trimester D&E through 20 weeks is safe and effective. Misoprostol may be less effective when used alone compared to overnight osmotic dilators for cervical preparation later in the second trimester but has adjunctive benefit on cervical dilation and procedure time when used with overnight osmotic dilators between 16 and 24 weeks. The effect appears most pronounced at N19 weeks gestation. No prospective studies have been published examining misoprostol as an adjunct to osmotic dilators for cervical preparation for same-day D&E.
Administration of adjunctive misoprostol with Dilapan-S has the potential to effectively prepare the cervix and decrease operative time for same-day D&E. We compared cervical preparation with Dilapan-S with and without adjunctive buccal misoprostol for same-day D&E between 16 0/7 and 20 6/7 weeks gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 18 years (no upper age limit)
- •Gestational age between 16+0 and 20+6 weeks gestation on day of D&E with confirmation of gestational age by ultrasound
- •Desires D&E for termination of pregnancy or for fetal demise
- •Able to provide written informed consent
- •Able to comply with study procedures
- •English-speaking
排除标准
- •Known allergy or contraindication to misoprostol
- •Pregnancy with a multiple gestation
- •Known bleeding disorder or current anticoagulation therapy (within one month of procedure)
- •Active bleeding or hemodynamically unstable at enrollment
- •Signs of chorioamnionitis or clinical infection at enrollment
- •Signs of spontaneous labor or cervical insufficiency at enrollment
研究组 & 干预措施
Misoprostol
Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
干预措施: Misoprostol (Drug)
Folic Acid
Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
干预措施: Folic Acid (Drug)
结局指标
主要结局
Operative Time
时间窗: Day 1 of the study
The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D\&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D\&E.
次要结局
- Number of Participants With Postoperative Satisfaction(Day 1)
- Complications(Day 1)
- Patient Pain(Day 1)
- Number of Providers With Overall Satisfaction(Day 1)
研究者
Christy Boraas
MD
University of Pittsburgh