A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Pregnancy Clinical Trial

Official title:

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02777190
• Other study ID #: 00005107
• Status: Terminated
• Phase: Phase 4
• Start date: November 1, 2017
• Est. completion date: April 23, 2019

Study information

• Verified date: October 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: April 23, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor; Forced or Induced, Affecting Fetus or Newborn
• Pregnancy

Intervention

Drug:
• Misoprostol
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Active Labor	Active phase of labor defined as greater than or equal to 6 cm cervical dilation	from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Secondary	Time to Initiation of Oxytocin for Labor Augmentation	The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation.	From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours
Secondary	Time to Vaginal Delivery	includes vaginal deliveries only; cesarean section deliveries are excluded	from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
Secondary	Cesarean Section Rate	Number of cesarean sections/total deliveries (%)	From enrollment until delivery, up to 3 days
Secondary	Rate of Tachysystole	Tachysystole is defined as 4 or more contractions in a 10 minute period.	from enrollment until delivery, up to 3 days
Secondary	Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones	Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant).	From enrollment until delivery, up to 3 days
Secondary	Rate of Need for Tocolysis	Tocolysis is the administration of medication to decrease or stop contractions.	from enrollment until delivery, up to 3 days
Secondary	Rate of Chorioamnionitis	Chorioamnionitis is defined as an intraamniotic infection.	from enrollment until delivery, up to 3 days
Secondary	Rate of Meconium Stained Fluid	Amniotic fluid with visible meconium (from fetal defecation) within it.	from enrollment until delivery, up to 3 days
Secondary	Neonatal Morbidity	binary composite outcome defined as Apgar score < 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery.	4 hours from delivery
Secondary	Rate of Anti-emetic Use	Use of medication to treat nausea.	from enrollment until delivery, up to 3 days
Secondary	Rate of Vaginal Delivery Within 24 Hours	Vaginal delivery within from start of induction with misoprostol.	24 hours from start of induction of labor (first misoprostol administration)
Secondary	Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening	Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead	from enrollment until delivery, up to 3 days