Comparison of Misoprostol Ripening Efficacy With Dilapan

Phase 4

Completed

Conditions: Labor Onset and Length Abnormalities
Induced; Birth

Interventions: Device: Dilapan
Drug: Misoprostol

Registration Number: NCT03670836

Lead Sponsor: Columbia University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 307

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilapan group	Dilapan	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.
Misoprostol group	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Bishop Score	Baseline and 12 hours after intervention	The Bishop Score (also known as Pelvic Score) is the most commonly used method to rate the readiness of the cervix for induction of labor. The Bishop Score gives points to 5 measurements of the pelvic examination dilation, effacement of the cervix, station of the fetus, consistency of the cervix, and position of the cervix. It ranges from 0 to 13. Higher score is associated with increased likelihood of vaginal delivery.
Percentage of Newborns With Apgar Score <7 at 5 Min	5 minutes following birth	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1	From birth until two weeks after birth	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention	Up to 24 hours after intervention	This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening
Overall Vaginal Delivery Rate	Approximately up to 48 hours	This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening
Total Length of Hospital Stay	Up to 4 days	This is to measure the cost-effectiveness of either Dilapan or Misoprostol for cervical ripening. Length will be measured in number of days from hospital admission until discharge.
Percentage of Women Who Developed Chorioamnionitis	From delivery until two weeks after discharge (approximately up to 3 weeks)	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening
Percentage of Women Who Developed Postpartum Hemorrhage	From delivery until two weeks after discharge (approximately up to 3 weeks)	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening, postpartum hemorrhage is defined as estimated blood loss (EBL) \> 1000cc and/or drop in Hematocrit (HCT) by 10 points.
Number of Participants With Cesarean Deliveries	Start of cervical ripening to delivery, up to 36 hours	This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening
Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention	From birth until two weeks after birth	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns
Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention	From birth until two weeks after birth	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns