Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor in Term or Post Term Pregnancies in Females With Pre-labor Rupture of Membranes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- induction of labor
研究概览
简要总结
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane.
Research Hypothesis:
In women undergoing induction of labor at term or post term with pre-labor rupture of membrane, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.
Research Questions:
Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane?
详细描述
- Study Design: Prospective double blinded randomized placebo-controlled Clinical trial
- Time plan: Approximately 6 months according to calculated sample size.
- study setting: this study will be conducted obstetrics and gynecology department at Cairo university.
- study population: patient will be recruited in this study those attending labor ward for induction of labor in term or post term pregnancies in females with pre-labor rupture of membranes
- Methodology in details
All women will be subjected to
-History taking:
- Verbal consent.
- Detailed clinical history.
- Personal history: Name, Age, Parity, Occupation, Residency and Special habits.
- Present history: History of onset, course and duration of vaginal bleeding or bloody vaginal discharge, presence of uterine contraction, PROM, IUGR or any indication of induction of labor.
- Obstetric history: History of previous preterm labor, previous abortion, previous full term deliveries, RH incompatibility, mode of delivery and fetal outcome.
- Menstrual history: For estimation of gestational age using Naegele's rule, provided that she had regular cycles for the last three months before she got pregnant and was not taking contraceptive pills during this period and she was sure of her dates.
Term pregnancy defined as delivery between 37 and 42 weeks of gestation. Gestational age was assessed from the menstrual history and confirmed by measurement of fetal crown-rump length at a first-trimester scan. Post-term pregnancy defined as delivery after 42 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who was receiving the actual drug and who was receiving a placebo.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy.
- •Cephalic presentation.
- •Bishop score < or =
- •Average size of the fetus.
- •Adequate pelvic dimensions.
- •Prelabour rupture of membranes.
- •Term or post-term pregnancies with an indication for labor induction either maternal or fetal.
排除标准
- •Previous uterine scar (e.g. caesarian delivery or unknown uterine incision , previous hysterotomy or myomectomy of the uterine corpus involving entry of the uterine cavity or extensive myometrial dissection, previous uterine rupture)
- •Patients with regular uterine contractions.
- •Malpresentation.
- •Multifetal gesta1tion.
- •Established fetal distress ( e.g. thick meconium stained liguor or non reassuring CTG changes)
- •Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
- •Placenta previa or vasa previa.
- •Active genital herpes infection.
- •Severe maternal illness (e.g. severe preeclampsia).
- •Laboratory and clinical sign of chorioamnionitis.
研究组 & 干预措施
isosorbide mono-nitrate group
70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)
干预措施: isosorbide mononitrate (Drug)
placebo group
70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
干预措施: Placebo (Drug)
结局指标
主要结局
induction of labor
时间窗: up to 24 hours
the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening for induction of labor at term or post term pregnancy with prelabor rupture of membrane regarding (Induction to onset of labor time, Induction to delivery time)
次要结局
未报告次要终点
研究者
ahmed nagy shaker ramadan
resident of obstetrics and gynecology
Cairo University