Oral Misoprostol Solution in Labor Induction

NCT ID: NCT03927807

Last Updated: 2019-04-25

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

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2020-01-18

Brief Summary

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This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

Detailed Description

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Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

Conditions

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Labour,Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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repetitive hourly dose of oral misoprostol

The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity.

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups.

Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity.

Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.

two hourly dose of oral misoprostol

The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity.

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups.

Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity.

Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.

Interventions

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Misoprostol

This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups.

Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity.

Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Nulliparas
* Term pregnancy(equal or more than 37 wks)
* Bishop score \<6
* Cephalic presentation
* reassuring fetal heart rate pattern
* Not in labor ( no uterine contractions)
* Clinically adequate pelvis
* Singleton live pregnancy

Exclusion Criteria

* Allergic to misoprostol or prostaglandin analogues
* Previous uterine scar( cesarean section,hysterotomy,myomectomy)
* Multiple fetal gestations
* Fetal demise
* Preterm labor
* Malpresentations
* Non reactive cardiotocography at admission
* Cephalo pelvic disproportion
* Fetal macrosomia
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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Esam salah mohamed hagag

Director,clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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essam sa hagag, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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essam sa hagag, MBBCh

Role: CONTACT

01066813830

Facility Contacts

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esam sa hagag, MBBCh

Role: primary

01066813830

References

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27986461

Reference Type RESULT

Other Identifiers

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misoprostol in induction

Identifier Type: -

Identifier Source: org_study_id

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