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

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

Sponsors

Lead Sponsor: Ain Shams University

Source 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.

Overall Status Unknown status
Start Date 2010-11-01
Completion Date 2011-09-01
Primary Completion Date 2011-04-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
the duration of the first stage of labor 6 monthes
effect on the duration of the 1st stage of labor 6 monthes
Secondary Outcome
Measure Time Frame
effect on pain 6 monthes
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Meperidine

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

Arm Group Label: meperidine and duration of 1st stage of labor

Intervention Type: Drug

Intervention Name: Drotaverine

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

Arm Group Label: drotaverine and duration of 1st stage of labor

Eligibility

Criteria:

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.

Gender:

Male

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: mahmoud mohamed

Phone: 0020106981179

Email: [email protected]

Location
Facility: Contact: Contact Backup: Mahmoud 0020106981179
Location Countries

Egypt

Verification Date

2010-11-01

Responsible Party

Name Title: ain shams university

Organization: ain shams university

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: meperidine and duration of 1st stage of labor

Type: Experimental

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

Label: drotaverine and duration of 1st stage of labor

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: Double (Participant, Investigator)

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