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Verified  2010-11 by ain shams university
Last known status was: Not yet recruiting

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

ClinicalTrials.gov ID NCT01236651
Sponsor Ain Shams University
Information provided by Ain Shams University
Last Update Posted 2010-11-09
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Study Overview

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.

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Official Title
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Conditions
Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
Intervention / Treatment
  • Drug: Meperidine
  • Drug: Drotaverine
  • Drug: Meperidine
  • Drug: Drotaverine
Other Study ID Numbers
  • dr hegab protocol
Study Start
2010-11
Primary Completion (Estimated)
2011-04
Study Completion (Estimated)
2011-09
Enrollment (Estimated)
200
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: mahmoud mohamed

Phone Number: 0020106981179

Email: hegab_2008@yahoo.com

Study Contact Backup

Name: M H

Phone Number: 0020114440015

Email: hegab_2008@yahoo.com

Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Ages Eligible for Study
(ChildAdultOlder Adult )
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Diagnostic
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Double (ParticipantInvestigator)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: 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
Intervention/Treatment Drug: Meperidine
  • administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor

Participant Group/Arm Experimental: 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
Intervention/Treatment Drug: Drotaverine
  • administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
the duration of the first stage of laborthe primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor6 monthes
effect on the duration of the 1st stage of laborthe primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor6 monthes
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
effect on pain 6 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Ain Shams University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2010-11-08
First Submitted that Met QC Criteria
2010-11-08
First Posted (Estimated)
2010-11-09
Study Record Updates
Last Update Submitted that met QC Criteria
2010-11-08
Last Update Posted (Estimated)
2010-11-09
Last Verified
2010-11

More Information

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Additional Relevant MeSH Terms