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

NCT01236651 | Unknown Phase 2 DMC

• 1 other identifier: dr hegab protocol
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• effect on pain

  6 monthes

Study Arms (2)

meperidine and duration of 1st stage of labor

EXPERIMENTAL

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

Drug: Meperidine

drotaverine and duration of 1st stage of labor

EXPERIMENTAL

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

Drug: Drotaverine

Interventions

Meperidine DRUG

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

meperidine and duration of 1st stage of labor

Drotaverine DRUG

administer 40mg drotaverine 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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Mahmoud

Cairo, Egypt

Location

MeSH Terms

Interventions

Meperidine; drotaverin

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

mahmoud mohamed

CONTACT

0020106981179; hegab_2008@yahoo.com

M H

CONTACT

0020114440015; hegab_2008@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

EG (1)