Brief 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.
Brief Title
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
Detailed 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.
Completion Date
Completion Date Type
Actual
Conditions
Labor; Forced or Induced, Affecting Fetus or Newborn
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Any pregnant woman undergoing induction of labor
* Live singleton pregnancy ≥ 37 week gestation
* Bishop score \< 6
* Category I fetal heart rate
* Any pregnant woman undergoing induction of labor
* Live singleton pregnancy ≥ 37 week gestation
* Bishop score \< 6
* Category I fetal heart rate
Gender
Female
Gender Based
false
Keywords
unripe cervix
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
45 Years
Minimum Age
18 Years
NCT Id
NCT02680314
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5341
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Participants With Vaginal Delivery Within 24 Hours
Outcome Time Frame
within 24 hours
Secondary Outcomes
Outcome Description
To determine the interval from initiation of misoprostol to delivery in each group
Outcome Time Frame
within 24 hours from the initial intervention
Outcome Measure
To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
45
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Pamela Tropper
Investigator Email
PATROPPE@montefiore.org
Investigator Phone