NCT03863392

Brief Summary

Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods. To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

February 18, 2019

Last Update Submit

March 2, 2019

Conditions

Normal Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

  • •Induction-delivery time

    2 hours

Study Arms (2)

oral

EXPERIMENTAL

patients undergoing induction of labour using misoprostol oral solution

Drug: Misoprostol

vaginal

EXPERIMENTAL

patients undergoing induction of labour using vaginal misoprostol

Drug: Misoprostol

Interventions

MisoprostolDRUG

induction of labor

oralvaginal

Eligibility Criteria

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

You may qualify if:

  • Primigravida or Primipara
  • Pregnancy between 36 and 42 weeks of gestation.
  • A live singleton fetus in cephalic presentation.
  • No history of uterine surgery.
  • Clinically adequate pelvis.
  • Modified Bishop's score \<5.
  • Reactive Non stress test (NST) .

You may not qualify if:

  • Known hypersensitivity or contraindications to oral misoprostol (uterine surgery).
  • Any antenatal medical complications.
  • A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress
  • Non-reactive NST.
  • Patient's refusal to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

February 18, 2019

First Posted

March 5, 2019

Study Start

June 15, 2018

Primary Completion

November 29, 2018

Study Completion

March 15, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

EG(1)