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

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489798
• Other study ID #: MHST2016-04
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: September 15, 2018

Study information

• Verified date: October 2018
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: September 15, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Procedure:
• 6 misoprostol
Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
• 3 misoprostol
Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (2)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama	Sistema Nacional de Investigadores de Panamá

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal birth	Number of patients that had a vaginal birth	48 hours
Secondary	Maternal complications	Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony).	48 hours
Secondary	Fetal complications	Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress).	48 hours