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

Not Applicable

Completed

• Conditions: Induction of Labor
• Interventions: Procedure: 6 misoprostol; Procedure: 3 misoprostol

• Registration Number: NCT03489798
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-29
• Study Start: 2018-04-05
• Study First Posted: 2018-04-05
• Primary Completion: 2018-05-31
• Study Completion: 2018-09-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 310

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 Misoprostol	6 misoprostol	Up to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score \> 6.
3 misoprostol	3 misoprostol	Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score \> 6.

Primary Outcome Measures

Name	Time	Method
Vaginal birth	48 hours	Number of patients that had a vaginal birth

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama