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

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: Meperidine
* Drug: Drotaverine


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meperidine and duration of 1st stage of labor<br>meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor | Drug: Meperidine<br>* administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor<br>|
| Experimental: drotaverine and duration of 1st stage of labor<br>drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor | Drug: Drotaverine<br>* administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on pain |  | 6 monthes |