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

Phase 2

• Conditions: Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
• Interventions: Drug: Meperidine; Drug: Drotaverine

• Registration Number: NCT01236651
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Last Update Submitted: 2010-11-08
• Study First Posted: 2010-11-09
• Last Update Posted: 2010-11-09
• Primary Completion: 2011-04
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

● primigravida.

• 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

● Abnormal presentation or occipito posterior position.

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
meperidine and duration of 1st stage of labor	Meperidine	meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor
drotaverine and duration of 1st stage of labor	Drotaverine	drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor

Primary Outcome Measures

Name	Time	Method
the duration of the first stage of labor	6 monthes	the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor
effect on the duration of the 1st stage of labor	6 monthes	the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor

Secondary Outcome Measures

Name	Time	Method
effect on pain	6 monthes

Trial Locations

Locations (1)

Mahmoud; 🇪🇬 Cairo, Egypt