NCT03489798

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Saint Thomas Hospital, Panama · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Induction of Labor

Interventions

Type	Name	Description
PROCEDURE	6 misoprostol	Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score \> 6.
PROCEDURE	3 misoprostol	Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score \> 6.

Timeline

• Start date: 2018-04-05
• Primary completion: 2018-05-31
• Completion: 2018-09-15
• First posted: 2018-04-05
• Last updated: 2018-10-12

Locations

1 site across 1 country: Panama