Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.
- Conditions
- Induction of Labor
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 310
- Pregnant women between 34 and 42 weeks of gestation.
- Obstetric indication for termination of pregnancy.
- No fetal evidence of fetal distress
- Any contraindication for the use of misoprostol.
- Oligohydramnios.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Saint Thomas Maternity Hospital🇵🇦Panama, Panama