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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02777190
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor; Forced or Induced, Affecting Fetus or Newborn; Pregnancy	Drug: Misoprostol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Apr 23, 2019
• Actual Study Completion Date: Apr 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral misoprostol oral misoprostol given 25 mcg every 2 hours	Drug: Misoprostol; Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.; Other Names: Cytotec
Active Comparator: Vaginal misoprostol vaginal misoprostol given 25 mcg every 4 hours	Drug: Misoprostol; Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.; Other Names: Cytotec

Outcome Measures

Primary Outcome Measures

1. Time to active labor [from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.]

   Active phase of labor defined as greater than or equal to 6 cm cervical dilation

Secondary Outcome Measures

1. Time to initiation of oxytocin for labor augmentation [from start of induction of labor (first misoprostol administration) to initiation of oxytocin, up to 2 days]

2. Time to vaginal delivery [from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days]

   includes vaginal deliveries only; cesarean section deliveries are excluded

3. cesarean section rate [from enrollment until delivery]

4. rate of tachysystole [from enrollment until delivery]

5. rate of tachysystole causing non-reassuring fetal heart tones [from enrollment until delivery]

6. rate of need for tocolysis [from enrollment until delivery]

7. rate of chorioamnionitis [from enrollment until delivery]

8. rate of meconium stained fluid [from enrollment until delivery]

9. neonatal morbidity [4 hours from delivery]

   composite outcome of Apgar score < 7, cord blood gases (pH of less than 7 or base deficit great than 12), and neonatal intensive care unit admission within 4 hours of delivery

10. rate of anti-emetic use [from enrollment until delivery]

11. rate of diarrhea [from enrollment until delivery]

12. rate of vaginal delivery within 24 hours [24 hours from start of induction of labor (first misoprostol administration)]

13. rate of abandoning misoprostol for cervical ripening and switching to mechanical dilation for cervical ripening [from enrollment until delivery]

14. rate of development of preeclampsia requiring magnesium sulfate administration [from enrollment until delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Jaimey Pauli, MD, Milton S. Hershey Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaimey M. Pauli, MD, Principal Investigator, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02777190
• Other Study ID Numbers: 00005107
• First Posted: May 19, 2016
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jaimey M. Pauli, MD, Principal Investigator, Milton S. Hershey Medical Center: misoprostol; cytotec; cervical ripening; labor, induced; active labor
• Additional relevant MeSH terms: Misoprostol

Study Results

No Results Posted as of Jul 6, 2022