Cervical Ripening With Misoprostol Versus Isosorbide Mononitrate in Late-term Pregnancies: A Prospective Parallel -Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cervical Ripening Success
研究概览
简要总结
This randomized controlled trial compared misoprostol and isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. Low-risk women at 41+6 weeks gestation with an unfavorable cervix were randomized to receive either misoprostol or IMN. The primary outcome was the achievement of cervical ripeness (Bishop Score ≥6) within 40 hours.
详细描述
This randomized controlled trial evaluates the effectiveness and safety of misoprostol versus isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies (≥41+0 weeks gestation). Favorable cervical status, reflected by a Bishop Score ≥6, is critical for successful vaginal delivery. Participants are low-risk pregnant women at 41+6 weeks with an unfavorable cervix. They are randomized to receive either 25 mcg of vaginal misoprostol or 40 mg of vaginal IMN, administered every 4 hours for up to 3 doses. Cervical status is assessed at regular intervals to determine the achievement of cervical ripening within 40 hours.
The primary outcome is the proportion of participants achieving a Bishop Score ≥6. Secondary outcomes include maternal parameters (labor progression, cesarean section rate, postpartum hemorrhage) and neonatal outcomes (Apgar scores, fetal heart rate tracing, and Doppler indices). The study aims to determine which agent more effectively facilitates cervical ripening and supports favorable delivery outcomes in late-term pregnancies.
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 (Outcomes Assessor)
盲法说明
blinded assessors
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
- •Low-risk primigravidae
- •Singleton viable pregnancy
- •Cephalic fetal presentation
- •Confirmed gestational age ≥ 41+0/7 weeks
- •Normal fetal growth pattern
- •No signs of labor at the time of enrollment
排除标准
- •High-risk pregnancies
- •Body mass index (BMI) > 30 kg/m²
- •History of unexplained fetal death
- •Oligohydramnios or fetal distress
- •Abnormal placentation
- •Rh-negative status
- •Pre-existing medical conditions or contraindications to labor induction or study drugs
- •Fetal abnormalities
- •Malpresentation or malposition
- •Inadequate pelvimetry
- •Participants who developed fetal distress or failed to progress during induction and required emergency cesarean section
研究组 & 干预措施
Misoprostol group
Misoprostol Group Arm Type: Experimental
Arm Description:
Participants in this group received 25 µg of Misoprostol (Vagiprost; ADWIA Co/Egypt) administered vaginally every 4 hours, up to a maximum of 3 doses, for cervical ripening before induction of labor.
Assigned Intervention:
Drug Name: Misoprostol
• Other Names: Vagiprost, synthetic prostaglandin E1
干预措施: Misoprostol 25 µg Vaginal (Drug)
Isosorbide Mononitrate Group
The Isosorbide Mononitrate group (n=40) were nitric acid donor cases applied to the posterior fornix prior to induction of labor. Isosorbide mononitrate (IMN) (Monomack; Mack Pharmaceutics; Jordan) in a vaginal dose of 40 mg was used every 4 hours (up to 3 doses).
干预措施: Isosorbide Mononitrate (Drug)
结局指标
主要结局
Cervical Ripening Success
时间窗: Time Frame: Up to 40 hours post-intervention
Proportion of participants achieving Bishop Score ≥6 within 40 hours after receiving Misoprostol or Isosorbide Mononitrate. Unit of Measure: Percentage of participants (%)
次要结局
未报告次要终点
研究者
Raid M. Al-Ani
Professor
University Of Anbar