NCT02732522

Brief Summary

To analyze whether there is a statistically significant difference in the modifications present in the uterine cervix 6 hours after administration of misoprostol 50 µg through vaginal versus sublingual routes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

March 28, 2016

Last Update Submit

April 4, 2016

Conditions

Cervical Ripening

Keywords

misoprostolinduction of laborsublingual

Outcome Measures

Primary Outcomes (1)

  • Bishop score at 6 hours after administration of misoprostol

    6 hours

Secondary Outcomes (7)

  • Number of participants with Tachysystole

    6 hours

  • Number of patients who ended their pregnancy by caesarean section

    From administration of misoprostol to birth, up to 3 days.

  • Requirement of further doses of misoprostol

    From administration of misoprostol to birth, up to 3 days.

  • Labor within 6 hours

    6 hours

  • Apgar score at 1 minute

    At the first minute after delivery

  • +2 more secondary outcomes

Study Arms (2)

Misoprostol sublingual

EXPERIMENTAL
Drug: Sublingual misoprostol

Misoprostol vaginal

ACTIVE COMPARATOR
Drug: Vaginal misoprostol

Interventions

Sublingual misoprostolDRUG
Misoprostol sublingual
Vaginal misoprostolDRUG
Misoprostol vaginal

Eligibility Criteria

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

You may qualify if:

  • All pregnant women admitted at Pereira Rossell Hospital Center
  • Gestational ages between 32/0 and 41/6 according to first trimester sonogram
  • A viable fetus in cephalic presentation
  • Estimated fetal weight lower than 4000 gr
  • Without contraindications for vaginal birth
  • Whom induction of labor with misoprostol had been previously indicated, from 8 to 20 hours 7 days a week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Conde A, Ben S, Tarigo J, Artucio S, Varela V, Grimaldi P, Sosa C, Alonso J. Comparison between vaginal and sublingual misoprostol 50 microg for cervical ripening prior to induction of labor: randomized clinical trial. Arch Gynecol Obstet. 2017 Apr;295(4):839-844. doi: 10.1007/s00404-017-4297-9. Epub 2017 Feb 16.

    PMID: 28204882DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 8, 2016

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

January 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04