Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.

Study Overview
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Brief Summary
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To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.

Official Title
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Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.

Conditions
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Induction of Labor

Intervention / Treatment
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* Procedure: 6 misoprostol
* Procedure: 3 misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between 34 and 42 weeks of gestation. Obstetric indication for termination of pregnancy. No fetal evidence of fetal distress Exclusion Criteria: Any contraindication for the use of misoprostol. Oligohydramnios.
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 |
| --- | --- |
| Experimental: 6 Misoprostol<br>Up to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. | Procedure: 6 misoprostol<br>* Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.<br>* Other names: Prostaglandin E1 25 ug dose;|
| Active Comparator: 3 misoprostol<br>Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6. | Procedure: 3 misoprostol<br>* Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.<br>* Other names: Prostaglandin E1 25 ug dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal birth | Number of patients that had a vaginal birth | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal complications | Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony). | 48 hours | 
| Fetal complications | Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress). | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of labor, Misoprostol, Failed induction