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

NCT03489798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2018-10-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sistema Nacional de Investigadores de Panamá

    collaborator UNKNOWN

  • Saint Thomas Hospital, Panama

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2018-05-31
Completion
2018-09-15

Countries

  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489798 on ClinicalTrials.gov