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Completed

NCT Number: NCT03489798

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

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.

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Key information

Conditions

Induction of Labor

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Maternity Hospital

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

6 misoprostol

Procedure

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

Other names: Prostaglandin E1 25 ug dose

3 misoprostol

Procedure

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

Other names: Prostaglandin E1 25 ug dose

Primary outcomes

  1. Vaginal birth

    Time frame: 48 hours

    Number of patients that had a vaginal birth

Secondary outcomes

  1. Maternal complications

    Time frame: 48 hours

    Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony).

  2. Fetal complications

    Time frame: 48 hours

    Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress).

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Collaborators

  • Sistema Nacional de Investigadores de Panamá

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2018
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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