A Pilot Study of Priming Before Induction Termination of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Length of time between the start and the finish of the induction
研究概览
简要总结
Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours from the start of medication (misoprostol) to expulsion of the fetus. The objective of this study is to evaluate a method of 'priming' on the length of induction termination of pregnancy. "Priming" refers to the use of medication to ready the cervix and uterus so that the uterus is more sensitive to medication and contracts more effectively, and also refers to softening of the cervix so that there is less resistance to dilation. Priming is used extensively before induction of labor for term pregnancy and is also used extensively before surgical abortion in second trimester. We would like to add priming the evening before induction to the usual treatment and evaluate whether the length of the induction process is shortened. Women are admitted to the hospital in the morning to start misoprostol medication, and unless expulsion occurs within 8-10 hours, need to stay overnight.
The study design is to give the priming dose 12 hours before admission. The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus.
This study aims to assess whether the use of misoprostol as a priming agent would be beneficial with women who undergo induction termination of pregnancy.
详细描述
This is a prospective series. All women enrolled will receive the same treatment. 10 women without prior births and 10 women with prior births will be enrolled. The study design is to give the priming dose 12 hours before admission.
The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus.
Inclusion criteria: Women who have requested induction abortion and completed the counseling and consent process for abortion. Women 18 years of age or over. Capable of giving informed consent. Speak English or Spanish Pregnancy 18-23 weeks. No contraindication to misoprostol abortion
Exclusion criteria: Unable to understand and give informed consent. Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment. Ruptured membranes or signs of infection (temperature over 100.6 F,WBC >15K) Fetal demise Multi-fetal pregnancy Contraindication to any of the agents used for misoprostol induction abortion
After women have started the abortion process (completed counseling and consent for abortion, and completed the fetocidal digoxin injection), they will be approached by one of the investigators. The procedures and the consent process will be explained. If they consent, they will be given an envelope which contains 50 mcg of misoprostol (1/2 of a 100 mcg tablet). They will be instructed to place the tablet buccally and hold it in place for 30 minutes, after which it can be swallowed, between 8 and 9 pm that evening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or over
- •able to give informed consent in English or Spanish
- •requesting termination of pregnancy
- •pregnancy 18-23 weeks of gestation
排除标准
- •Unable to understand and give informed consent
- •Under 18 years of age
- •Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment
- •Ruptured membranes or signs of infection (temperature over 100.6 F,WBC >15K)
- •Fetal demise, Multi-fetal pregnancy contraindication to misoprostol
- •contraindication to misoprostol
结局指标
主要结局
Length of time between the start and the finish of the induction
时间窗: 24 h
次要结局
- incidence of nausea and cramping(24 h)