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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Dose<br>single dose of misoprostol | Drug: Misoprostol<br>* 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.<br>* Other names: cytotec, methotrexate;|
| Active Comparator: Multiple Dose<br>multiple doses of misoprostol | Drug: Misoprostol<br>* 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.<br>* Other names: cytotec, methotrexate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unripe cervix