NCT03489798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

February 13, 2018

Last Update Submit

October 10, 2018

Conditions

Induction of Labor

Keywords

Induction of laborMisoprostolFailed induction

Outcome Measures

Primary Outcomes (1)

  • Vaginal birth

    Number of patients that had a vaginal birth

    48 hours

Secondary Outcomes (2)

  • Maternal complications

    48 hours

  • Fetal complications

    48 hours

Study Arms (2)

6 Misoprostol

EXPERIMENTAL

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

Procedure: 6 misoprostol

3 misoprostol

ACTIVE COMPARATOR

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

Procedure: 3 misoprostol

Interventions

6 misoprostolPROCEDURE

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

Also known as: Prostaglandin E1 25 ug dose
6 Misoprostol
3 misoprostolPROCEDURE

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

Also known as: Prostaglandin E1 25 ug dose
3 misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women between 34 and 42 weeks of gestation.
  • Obstetric indication for termination of pregnancy.
  • No fetal evidence of fetal distress

You may not qualify if:

  • Any contraindication for the use of misoprostol.
  • Oligohydramnios.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

MeSH Terms

Interventions

Alprostadil

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator - Head: Research Department

Study Record Dates

First Submitted

February 13, 2018

First Posted

April 5, 2018

Study Start

April 5, 2018

Primary Completion

May 31, 2018

Study Completion

September 15, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

PA(1)