Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

Labor; Forced or Induced, Affecting Fetus or Newborn Clinical Trial

Official title:

Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680314
• Other study ID #: 2015-5341
• Status: Completed
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: June 16, 2021

Study information

• Verified date: August 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery as compared to using more than one dose of misoprostol, followed by treatment with oxytocin.

Description:

This study involves a comparison of two different regimens of prostaglandin use for "cervical ripening" prior to induction of labor. Women admitted to the hospital for induction of labor who are found to have "unripe" cervixes at the time of admission, and who agree to participate in the study will be randomly assigned to one of two treatment groups. In one group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours later oxytocin induction will be started if clinically indicated. In the second group of women, repeat doses of misoprostol will be given every four hours up to six doses unless labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed. Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and cesarean section rates will be compared. Complications such as postpartum hemorrhage, episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: June 16, 2021
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Any pregnant woman undergoing induction of labor

• Live singleton pregnancy = 37 week gestation

• Bishop score < 6

• Category I fetal heart rate

Exclusion Criteria:

• Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)

• Pregnancies complicated by major fetal anomalies

• Any contraindication to the use of misoprostol, including

• History of previous c-section or major uterine surgery

• Prior allergic reaction

• Category II or III fetal heart rate

• Regular uterine contractions = 3 in a 10-minute period persistent for at least 30 minutes

• Estimated fetal weight < 10 percentile

• Premature rupture of membranes

• Age < 18 years old

• Women who do not have the capacity to consent

Related Conditions & MeSH terms

• Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention

Drug:
• Misoprostol
Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Vaginal Delivery Within 24 Hours	To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.	within 24 hours
Secondary	To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group	To determine the interval from initiation of misoprostol to delivery in each group	within 24 hours from the initial intervention