Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- procedure time
研究概览
简要总结
This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg administered 1.5 hours before D&E.
Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.
Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability
详细描述
The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.
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
- Single (Care Provider)
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
- •18 years of age and older
- •Eligible for pregnancy termination at Planned Parenthood of NYC
- •Able to give informed consent
- •English speaking
排除标准
- •Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
- •Intrauterine fetal demise identified on pre-operative ultrasound
- •Allergy to misoprostol
研究组 & 干预措施
400 mcg
receives 400 mcg of misoprostol 3 hours prior to the procedure
干预措施: Misoprostol 400 mcg 3 hours prior to procedure (Drug)
600 mcg
receives 600 mcg of misoprostol 90 minutes prior to the procedure
干预措施: Misoprostol 600 mcg 90 minutes prior to procedure (Drug)
结局指标
主要结局
procedure time
时间窗: day of abortion procedure
Operative time defined as time from speculum in vagina to speculum out of vagina.
次要结局
未报告次要终点