Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

NCT ID: NCT03863392

Last Updated: 2019-03-05

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-03-15

Brief Summary

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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.

Detailed Description

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Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room.

A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s).

II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.

Conditions

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Normal Vaginal Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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oral

patients undergoing induction of labour using misoprostol oral solution

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

induction of labor

vaginal

patients undergoing induction of labour using vaginal misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

induction of labor

Interventions

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Misoprostol

induction of labor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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) .

Exclusion Criteria

* •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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Peter rafik helmy thabet

Clinical investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ainshams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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test123

Identifier Type: -

Identifier Source: org_study_id

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