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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Ain Shams University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT01236651
First received: November 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
Drug: Meperidine
Drug: Drotaverine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • the duration of the first stage of labor [ Time Frame: 6 monthes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 monthes ] [ Designated as safety issue: No ]
    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:
  • effect on pain [ Time Frame: 6 monthes ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Meperidine
administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor
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
Drug: Drotaverine
administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236651

Contacts
Contact: mahmoud mohamed 0020106981179 hegab_2008@yahoo.com
Contact: M H 0020114440015 hegab_2008@yahoo.com

Locations
Egypt
Mahmoud Not yet recruiting
Cairo, Egypt
Contact    0020106981179      
Contact    0020123033223      
Sponsors and Collaborators
Ain Shams University
  More Information

No publications provided

Responsible Party: ain shams university
ClinicalTrials.gov Identifier: NCT01236651     History of Changes
Other Study ID Numbers: dr hegab protocol
Study First Received: November 8, 2010
Last Updated: November 8, 2010
Health Authority: Egypt:Ain shams university

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Meperidine
Drotaverin
Papaverine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Parasympatholytics
Autonomic Agents
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014