Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 2
- 主要终点
- Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population
研究概览
简要总结
The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.
详细描述
In developed nations 25 % of pregnant women undergo labor induction for various indications. Likelihood of vaginal delivery depends on the degree of ripeness of cervix. Majority of women undergoing induction of labor are candidates for cervical ripening. Dilapan is an osmotic hygroscopic dilator of cervix commonly used for cervical preparation for mid trimester abortions. It has been proven safe for use for induction of Labor (IOL) at term. Misoprostol is a synthetic prostaglandin E1 analogue, widely used for cervical ripening and IOL in United States and is considered as standard of care.
This is a non-inferiority, unblinded randomized, controlled trial where 322 eligible participants undergoing IOL at >37 weeks gestation and admitted to labor and delivery unit will be enrolled and randomly assigned in a ratio 1:1 to either receive Dilapan or Misoprostol for cervical ripening.
After randomization all participants will undergo assessment as per standard of care. Participants will have either 1-5 Dilapan rods inserted into their cervix by the providers or receive 25 mcg of misoprostol orally every 2 hours to a maximum of 6 doses over 12 hours. Participants will be evaluated for artificial rupture of membranes and initiation of oxytocin for inducing uterine contraction. A diagnosis of failed IOL will be made if patient does not go into active labor within 24 hours after initiation of Oxytocin and Artificial Rupture Of Membranes (AROM). Intrapartum management will be according to institutional guidelines. All participants will be followed up and contacted by phone 2 weeks after discharge regarding their experience with the method of induction.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing labor induction with a gestation of ≥37 weeks (based on a sure last menstrual period and an ultrasound done before 22 0/7 weeks)
- •Live fetus with in cephalic presentation
- •Singleton pregnancy
- •Able to provide informed consent for participation in the study
排除标准
- •Contraindication for vaginal delivery
- •Age less than 18 years
- •Prior uterine scar from a cesarean section or myomectomy
- •Patients who have HELLP syndrome or eclampsia
- •Active genital herpes at the time of labor induction
- •Complex medical problems that may require assistance with second stage of labor
- •Bishop score ≥ 6
- •Major fetal congenital anomalies (as assessed by investigator)
- •Premature rupture of membranes
研究组 & 干预措施
Dilapan group
Patients who are randomized to receive Dilapan, will have 3-5 rods of Dilapan-S® inserted in their cervix by the supervising provider, under aseptic precautions with a speculum exam, either digitally or using a sponge forceps, as per manufacturer's recommendations. The Bishop score at the time of eligibility assessment and number of rods inserted will be recorded. Dilapan will be left in cervix for 12 hours. Patients will be allowed to ambulate, shower and have light meals as long as they meet the criteria based on institutional guidelines for intermittent fetal heart monitoring. "Nothing per vagina" including douching and no bathing is allowed.
干预措施: Dilapan (Device)
Misoprostol group
Patients who are randomized to Misoprostol group, after the baseline assessment and a reassuring cardiotocograms (CTG) monitoring for 20 minutes to a maximum of 6 doses. All subjects will have continuous fetal monitoring. A dose will be held if patient is noted to have uterine tachysystole, hyperstimulation, fetal heart tracing abnormalities or 3 or more painful uterine contractions over a period of 10 minutes (indicating onset of labor). Administration of Misoprostol will be done by the nurse assigned to the patient.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population
时间窗: Up to 36 hours after intervention
This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening.
Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population
时间窗: Up to 36 hours after intervention
This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening. Intent-to-treat Population (ITT) includes all patients that were randomized into the study. ITT participants will be analyzed in accordance with their randomized study treatment (i.e. in the treatment group they were originally allocated, regardless of treatment actually received). ITT will be used for evaluation of the baseline characteristics and as the primary population for efficacy assessments.
次要结局
- Change in Bishop Score(Baseline and 12 hours after intervention)
- Percentage of Newborns With Apgar Score <7 at 5 Min(5 minutes following birth)
- Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1(From birth until two weeks after birth)
- Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention(Up to 24 hours after intervention)
- Overall Vaginal Delivery Rate(Approximately up to 48 hours)
- Total Length of Hospital Stay(Up to 4 days)
- Percentage of Women Who Developed Chorioamnionitis(From delivery until two weeks after discharge (approximately up to 3 weeks))
- Percentage of Women Who Developed Postpartum Hemorrhage(From delivery until two weeks after discharge (approximately up to 3 weeks))
- Number of Participants With Cesarean Deliveries(Start of cervical ripening to delivery, up to 36 hours)
- Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention(From birth until two weeks after birth)
- Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention(From birth until two weeks after birth)
研究者
Rachana Gavara
Assistant Professor of Obstetrics and Gynecology at the Columbia University Medical Center
Columbia University