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Effect of Hyoscine and Promethazine on Labor Pain

NCT ID: NCT01644838

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-04-30

Brief Summary

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It is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. So the investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on length of active phase of the first stage of labor.

Detailed Description

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Conditions

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Labor Pain

Keywords

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Hyoscine, Promethazine, The first stage of labor, Labor pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Promethazine

25 mg of promethazine

Group Type EXPERIMENTAL

Promethazine

Intervention Type DRUG

The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.

Hyoscine

20 mg of hyoscine

Group Type EXPERIMENTAL

Hyoscine

Intervention Type DRUG

The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.

Interventions

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Hyoscine

The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.

Intervention Type DRUG

Promethazine

The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-35 yrs,
* primiparous,
* having single fetus with cephalic presentation, gestational age 37-42 weeks,
* having no medical diseases,
* having no history of hospitalization due to psychological diseases,
* having no addiction to cigarette,
* having no complications during pregnancy such as hypertension,
* BMI\< 26

Exclusion Criteria

* bleeding
* CPD
* use of PG or Oxytocin
* fetus distress
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Samira Ebrahimzadeh Zagami

School of Nursing & Midwifery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Hyoscine & Promethazin

Identifier Type: -

Identifier Source: org_study_id