Effect of Hyoscine and Promethazine on Labor Pain

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01644838
• Collaborator: (none)
• Enrollment: 93
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Hyoscine; Drug: Promethazine	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Principal Investigator
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Effect of Hyoscine and Promethazine on labor pain [up to 9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mashhad University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samira Ebrahimzadeh Zagami, School of Nursing & Midwifery, Mashhad University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01644838
• Other Study ID Numbers: Hyoscine & Promethazin
• First Posted: Jul 19, 2012
• Last Update Posted: Jul 20, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Samira Ebrahimzadeh Zagami, School of Nursing & Midwifery, Mashhad University of Medical Sciences: Hyoscine,; Promethazine,; The first stage of labor,; Labor pain
• Additional relevant MeSH terms: Labor Pain; Promethazine; Diphenhydramine; Scopolamine

Study Results

No Results Posted as of Jul 20, 2012