Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- admission-delivery interval
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.
Research Hypothesis:
In women undergoing induction of labor, 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?
详细描述
- Type of Study : Prospective double blind randomized controlled clinical trial.
- Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital.
- Study Period : Expected 6 months from December 2023 to June 2024.
- Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).
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, Care Provider)
盲法说明
To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy.
- •Cephalic presentation.
- •Bishop score <
- •Average size of the fetus.
- •Adequate pelvic dimensions.
- •Term or post-term pregnancies with an indication for labor induction either maternal or fetal.
排除标准
- •• Previous uterine scar.
- •Patients with regular uterine contractions.
- •Malpresentation.
- •Multifetal gestation.
- •Prelabour rupture of membranes.
- •Established fetal distress.
- •Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
- •Antepartum hemorrhage.
- •Active genital herpes infection.
- •Severe maternal illness (e.g. severe preeclampsia).
研究组 & 干预措施
isosorbide mononitrate group
In vaginal IMN group (group 1) 40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.
干预措施: isosorbide mononitrate (Drug)
placebos group
In the placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
干预措施: Placebos (Drug)
结局指标
主要结局
admission-delivery interval
时间窗: up to 24 hours
The time from initiation labor induction and delivery of placenta
次要结局
未报告次要终点
研究者
ahmed nagy shaker ramadan
director
Cairo University