NCT03829592

Brief Summary

Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and 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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

First Submitted

Initial submission to the registry

February 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

February 1, 2019

Last Update Submit

May 16, 2020

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • The number of women who will start lactive phase of labour after treatment

    the number of women in a group who will enter in active labour faster than other groups

    within 24 hours

Study Arms (3)

misoprostol in neutral media

PLACEBO COMPARATOR

Intervention : misoprostol in a neutral media will be given to women to induce labour

Drug: misoprostol in a neutral media

Misoprostol in acidic media

ACTIVE COMPARATOR

Intervention : misoprostol in acidic media will be given to induce labour

Drug: misoprostol in an acidic media

Misoprostol in alkaline media

SHAM COMPARATOR

Intervention : misoprostol in alkaline media will be given to induce labour

Drug: misoprostol in an alkaline media

Interventions

misoprostol in a neutral mediaDRUG

giving misoprostol in a neutral media

Also known as: Drug (misoprostol + neutral media )
misoprostol in neutral media
misoprostol in an acidic mediaDRUG

giving misoprostol in an acidic media

Also known as: Drug ( Misoprostol + acidic media )
Misoprostol in acidic media
misoprostol in an alkaline mediaDRUG

giving misoprostol in an alkaline media

Also known as: Drug ( misoprostol + alkaline media )
Misoprostol in alkaline media

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFull term pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation

You may not qualify if:

  • \. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah and Kasralainy hospital

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

MisoprostolPharmaceutical Preparations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 paralle groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 4, 2019

Study Start

February 6, 2019

Primary Completion

May 10, 2020

Study Completion

July 12, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

EG(1)