Clinical trial NCT03670836: Comparison of Misoprostol Ripening Efficacy With Dilapan
Official title: Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Onset and Length Abnormalities
Induced; Birth
Keywords: Misoprostol
Dilapan
Induction of labor
Aquacryl hydrogel
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Medicem International CR s.r.o.
First posted: 2018-09-14
Enrollment: 307
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Live fetus with in cephalic presentation
3. Singleton pregnancy
4. Able to provide informed consent for participation in the study

Exclusion Criteria:

1. Contraindication for vaginal delivery
2. Age less than 18 years
3. Prior uterine scar from a cesarean section or myomectomy
4. Patients who have HELLP syndrome or eclampsia
5. Active genital herpes at the time of labor induction
6. Complex medical problems that may require assistance with second stage of labor
7. Bishop score ≥ 6
8. Major fetal congenital anomalies (as assessed by investigator)
9. Premature rupture of membranes

Primary outcomes:
measure: Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population
timeFrame: Up to 36 hours after intervention
measure: Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population
timeFrame: Up to 36 hours after intervention
Secondary outcomes:
measure: Change in Bishop Score
timeFrame: Baseline and 12 hours after intervention
measure: Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention
timeFrame: Up to 24 hours after intervention
measure: Overall Vaginal Delivery Rate
timeFrame: Approximately up to 48 hours
measure: Number of Participants With Cesarean Deliveries
timeFrame: Start of cervical ripening to delivery, up to 36 hours
measure: Total Length of Hospital Stay
timeFrame: Up to 4 days
measure: Percentage of Women Who Developed Chorioamnionitis
timeFrame: From delivery until two weeks after discharge (approximately up to 3 weeks)
measure: Percentage of Women Who Developed Postpartum Hemorrhage
timeFrame: From delivery until two weeks after discharge (approximately up to 3 weeks)
measure: Percentage of Newborns With Apgar Score <7 at 5 Min
timeFrame: 5 minutes following birth
measure: Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1
timeFrame: From birth until two weeks after birth
measure: Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention
timeFrame: From birth until two weeks after birth
measure: Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention
timeFrame: From birth until two weeks after birth
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian - Allen Hospital
state: New York
city: Galveston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: rg2460@cumc.columbia.edu
name: Rachana Gavara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gavara R, Saad AF, Wapner RJ, Saade G, Fu A, Barrow R, Nalgonda S, Bousleiman S, Almonte C, Alnafisee S, Holman A, Burgansky A, Heikkila P. Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1083-1091. doi: 10.1097/AOG.0000000000004799. Epub 2022 May 2.