TheEffect of pH on Misoprostol in Induction of Labor

NCT ID: NCT03829592

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2020-07-12

Brief Summary

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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 .

Detailed Description

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Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium

Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 paralle groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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misoprostol in neutral media

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

Group Type PLACEBO_COMPARATOR

misoprostol in a neutral media

Intervention Type DRUG

giving misoprostol in a neutral media

Misoprostol in acidic media

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

Group Type ACTIVE_COMPARATOR

misoprostol in an acidic media

Intervention Type DRUG

giving misoprostol in an acidic media

Misoprostol in alkaline media

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

Group Type SHAM_COMPARATOR

misoprostol in an alkaline media

Intervention Type DRUG

giving misoprostol in an alkaline media

Interventions

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misoprostol in a neutral media

giving misoprostol in a neutral media

Intervention Type DRUG

misoprostol in an acidic media

giving misoprostol in an acidic media

Intervention Type DRUG

misoprostol in an alkaline media

giving misoprostol in an alkaline media

Intervention Type DRUG

Other Intervention Names

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Drug (misoprostol + neutral media ) Drug ( Misoprostol + acidic media ) Drug ( misoprostol + alkaline media )

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 1\. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Alalfy

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Algazeerah and Kasralainy hospital

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Mahmoud Alalfy, master

Role: primary

+201002611058

Ahmed Elgazzar, M.D

Role: backup

+201014005959

Other Identifiers

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Misoprostol

Identifier Type: -

Identifier Source: org_study_id

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