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

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01236651
• Other study ID #: dr hegab protocol
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 8, 2010
• Last updated: November 8, 2010
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2010
• Source: Ain Shams University
• Contact: mahmoud mohamed
• Phone: 0020106981179
• Email: hegab_2008[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt:Ain shams university
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Drug:
• Meperidine
administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor
• Drotaverine
administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor

Locations

Country	Name	City	State
Egypt	Mahmoud	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the duration of the first stage of labor	the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor	6 monthes	No
Primary	effect on the duration of the 1st stage of labor	the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor	6 monthes	No
Secondary	effect on pain		6 monthes	No