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临床试验/NCT05696574
NCT05696574尚未招募不适用

Comparative Study Between Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women at or Beyond Completed 41 Weeks

Cairo University0 个研究点目标入组 80 人开始时间: 2023年1月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Onset of active stage of labor

研究概览

简要总结

The aim of this study is to compare the efficacy and the safety of vaginal misoprostol with oral misoprostol for induction of labor in nulliparous pregnant women at or beyond completed 41 weeks.

详细描述

Induction of labor is carried out for maternal and fetal indications and one of the most common indications is prolonged pregnancy.

Recent studies have suggested that by continuing pregnancy beyond 41 weeks, there is statistically significantly higher perinatal morbidity and mortality as well as an increased risk to the mother. Thus, there is a growing body of evidence suggesting the elective induction of labor at 41 weeks of gestation instead of expectant management.

Misoprostol, a prostaglandin E1 analog, is indicated for protection against gastric ulcers, but when administered prenatally it causes uterine contractions. Research exploiting this adverse effect has shown misoprostol to be superior to conventional methods for induction, resulting in shorter induction-to-delivery intervals, without any increase in adverse outcomes. It has the advantage of being cheap, stable at room temperature, and easy to be administered by various routes i.e., vaginal, oral, sublingual, or rectal.

The differential outcomes of oral versus vaginal misoprostol may be secondary to different pharmacokinetics for oral compared with vaginal misoprostol. Oral misoprostol undergoes rapid absorption from the gastrointestinal tract and rapid and extensive de-esterification during first-pass metabolism to an active metabolite, misoprostol, peaking at 15 minutes with a half-life of 20-40 minutes. Misoprostol then undergoes early rapid elimination over 120 minutes, followed by slow elimination thereafter. The medication rapidly makes its way to the myometrium. ln contrast, after vaginal misoprostol administration, plasma concentration gradually increase, reaching a maximum level after 70-80 minutes before slowly being eliminated with plasma levels still detectable 6 hours after administration.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal age: 18-
  • Nullipara: a woman who has never completed a pregnancy beyond 20 weeks gestation. She may not have been pregnant or may have had a spontaneous or elective abortion(s) or an ectopic pregnancy.
  • Single living pregnancy.
  • Gestational age: at or beyond completed 41 weeks (confirmed by a reliable date for the last menstrual period, regular cycle, or/and 1st trimesteric ultrasound scan).
  • Cephalic presentation.
  • Bishop score of 6 or less.
  • Reactive fetal non-stress test (NST).

排除标准

  • Any maternal chronic diseases or pregnancy-induced medical disorders.
  • Fetal anomalies.
  • Fetal macrosomia (>4 Kg).
  • Intrauterine Growth Restriction (IUGR) (EFW below the 10th percentile for gestational age).
  • Rupture of membranes or oligohydramnios (AFI < the fifth percentile).
  • Previous uterine scar.
  • Regular uterine contractions.
  • Any contraindication to vaginal delivery e.g., placenta previa (complete or partial covering of the internal os of the cervix with the placenta).

研究组 & 干预措施

Vaginal Misoprostol group

Experimental

Women in this group will include 40 pregnant women who will be offered misoprostol (placed in the post-fornix of the vagina) in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.

干预措施: Vaginal Misoprostol (Drug)

Oral Misoprostol group

Experimental

Women in this group will include 40 pregnant women who will be offered oral misoprostol in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.

干预措施: Oral Misoprostol (Drug)

结局指标

主要结局

Onset of active stage of labor

时间窗: 24 hours postoperatively

Duration to onset of active stage of labor

次要结局

  • Doses given(Intraoperativley)
  • Cesarean section rate in each group(Within 24 hours from drug induction)
  • Augmentation need(Intraoperatively)
  • Complications(48 hours Postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elsayed Fekry Elsayed Omran

Obstetrics and Gynecology Resident, Cairo University

Cairo University

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