Clinical trial NCT02777190: A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Official title: A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn
Pregnancy
Keywords: misoprostol
cytotec
cervical ripening
labor, induced
active labor
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 34
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 study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.


Eligibility criteria: Inclusion Criteria:

1. Pregnant Female Patients greater than or equal to 18 years of age
2. Induction of labor for a single live intrauterine pregnancy
3. Greater than or equal to 37 weeks gestational age
4. Cephalic presentation
5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))
6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
7. Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

1. Previous uterine scar
2. Contraindication to vaginal delivery
3. Patients with preeclampsia
4. Grand multiparty - greater than or equal to 5 live births or stillbirths
5. Premature rupture of membranes
6. Suspected intrauterine growth restriction
7. Fetal anomalies
8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)

Primary outcomes:
measure: Time to Active Labor
timeFrame: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Secondary outcomes:
measure: Time to Initiation of Oxytocin for Labor Augmentation
timeFrame: From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours
measure: Time to Vaginal Delivery
timeFrame: from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
measure: Cesarean Section Rate
timeFrame: From enrollment until delivery, up to 3 days
measure: Rate of Tachysystole
timeFrame: from enrollment until delivery, up to 3 days
measure: Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones
timeFrame: From enrollment until delivery, up to 3 days
measure: Rate of Need for Tocolysis
timeFrame: from enrollment until delivery, up to 3 days
measure: Rate of Chorioamnionitis
timeFrame: from enrollment until delivery, up to 3 days
measure: Rate of Meconium Stained Fluid
timeFrame: from enrollment until delivery, up to 3 days
measure: Neonatal Morbidity
timeFrame: 4 hours from delivery
measure: Rate of Anti-emetic Use
timeFrame: from enrollment until delivery, up to 3 days
measure: Rate of Vaginal Delivery Within 24 Hours
timeFrame: 24 hours from start of induction of labor (first misoprostol administration)
measure: Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening
timeFrame: from enrollment until delivery, up to 3 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jaimey Pauli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.