Effect of Hyoscine and Promethazine on Labor Pain

Labor Pain Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644838
• Other study ID #: Hyoscine & Promethazin
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 17, 2012
• Last updated: July 19, 2012
• Start date: August 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Hyoscine
The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.
• Promethazine
The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Hyoscine and Promethazine on labor pain		up to 9 months	Yes