Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

NCT ID: NCT01236651

Last Updated: 2010-11-09

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Detailed Description

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Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Protocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics \& Gynecology

The aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.

Conditions

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Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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meperidine and duration of 1st stage of labor

meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor

Group Type EXPERIMENTAL

Meperidine

Intervention Type DRUG

administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor

drotaverine and duration of 1st stage of labor

drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor

Group Type EXPERIMENTAL

Drotaverine

Intervention Type DRUG

administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor

Interventions

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Meperidine

administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor

Intervention Type DRUG

Drotaverine

administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancy.
* Term gestation i.e, 38-41 weeks.
* Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
* Vertex presentation with occipito anterior position.
* Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.

Exclusion Criteria

* Multiple pregnancies.
* Cephalo-pelvic disproportion.
* Cervical surgery in the past or history of cervical injury.
* Patients on antihypertensive therapy.
* Known hypersensitivity to drotaverine or meperidine.
* If any other spasmolytic agent had been used within 48 hours.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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ain shams university

Locations

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Mahmoud

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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mahmoud mohamed

Role: CONTACT

Phone: 0020106981179

Email: [email protected]

M H

Role: CONTACT

Phone: 0020114440015

Email: [email protected]

Facility Contacts

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Role: primary

Role: backup

Other Identifiers

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dr hegab protocol

Identifier Type: -

Identifier Source: org_study_id