Effect of Hyoscine and Promethazine on Labor Pain

July 19, 2012 updated by: Samira Ebrahimzadeh Zagami, Mashhad University of Medical Sciences

Principal Investigator

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Promethazine
25 mg of promethazine
Drug: Promethazine
The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.
EXPERIMENTAL: Hyoscine
20 mg of hyoscine
Drug: Hyoscine
The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of Hyoscine and Promethazine on labor pain
Time Frame: up to 9 months
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (ESTIMATE)

July 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hyoscine & Promethazin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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