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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03489798
Enrollment
310
Registered
2018-04-05
Start date
2018-04-05
Completion date
2018-09-15
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor

Keywords

Induction of labor, Misoprostol, Failed induction

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.

Interventions

PROCEDURE6 misoprostol

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

PROCEDURE3 misoprostol

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

Sponsors

Sistema Nacional de Investigadores de Panamá
CollaboratorUNKNOWN
Saint Thomas Hospital, Panama
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Vaginal birth48 hoursNumber of patients that had a vaginal birth

Secondary

MeasureTime frameDescription
Maternal complications48 hoursNumber of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony).
Fetal complications48 hoursNumber of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress).

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026