NCT02168881

Brief Summary

This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

June 19, 2014

Last Update Submit

June 19, 2014

Conditions

Labour Induction

Keywords

labourinductionmisoprostoldinoprostone

Outcome Measures

Primary Outcomes (1)

  • induction delivery time

    2 hourly

Study Arms (2)

misoprostol

ACTIVE COMPARATOR

oral misoprostol in solution 25 microgram every 2 hours

Drug: Misoprostol

dinoprostone

ACTIVE COMPARATOR

3 mgs dinoprostone vaginally every six hours

Drug: Dinoprostone

Interventions

MisoprostolDRUG
misoprostol
DinoprostoneDRUG
dinoprostone

Eligibility Criteria

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

You may qualify if:

  • Primigravida
  • \>37 wks

You may not qualify if:

  • Scarred uterus
  • Macrosomia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity hospital

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.

    PMID: 34155622DERIVED

MeSH Terms

Interventions

MisoprostolDinoprostone

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Marwan Osama Elkady

CONTACT

+201205533315

Study Design

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

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 20, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

EG(1)