Back to resultsMeperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Primary Purpose
Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Meperidine
Drotaverine
Sponsored by
About this trial
This is an interventional diagnostic trial for Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
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.
Sites / Locations
- Mahmoud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
meperidine and duration of 1st stage of labor
drotaverine and duration of 1st stage of labor
Arm Description
meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor
drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
effect on pain
Full Information
NCT ID
NCT01236651
First Posted
November 8, 2010
Last Updated
November 8, 2010
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT01236651
Brief Title
Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Official Title
Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
meperidine and duration of 1st stage of labor
Arm Type
Experimental
Arm Description
meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor
Arm Title
drotaverine and duration of 1st stage of labor
Arm Type
Experimental
Arm Description
drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor
Intervention Type
Drug
Intervention Name(s)
Meperidine
Intervention Description
administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor
Intervention Type
Drug
Intervention Name(s)
Drotaverine
Intervention Description
administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor
Primary Outcome Measure Information:
Title
the duration of the first stage of labor
Description
the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor
Time Frame
6 monthes
Title
effect on the duration of the 1st stage of labor
Description
the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor
Time Frame
6 monthes
Secondary Outcome Measure Information:
Title
effect on pain
Time Frame
6 monthes
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mahmoud mohamed
Phone
0020106981179
Email
hegab_2008@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
M H
Phone
0020114440015
Email
hegab_2008@yahoo.com
Facility Information:
Facility Name
Mahmoud
City
Cairo
Country
Egypt
Facility Contact:
Phone
0020106981179
Phone
0020123033223
12. IPD Sharing Statement
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Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae
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