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CompletedNCT01644838Updated Jul 20, 2012

Effect of Hyoscine and Promethazine on Labor Pain

A Phase 2/3 interventional study of Hyoscine and Promethazine in Labor Pain, sponsored by Mashhad University of Medical Sciences. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by Mashhad University of Medical Sciences · Phase 2/3 and Interventional

Phase
Phase 2/3
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
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Study 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.

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Conditions studied

  • Labor Pain

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Keywords

  • Hyoscine,
  • Promethazine,
  • The first stage of labor,
  • Labor pain
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 93 is close to the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

Exclusion Criteria:

  • bleeding
  • CPD
  • use of PG or Oxytocin
  • fetus distress
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Study design

Phase
Phase 2 / Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Promethazine

    25 mg of promethazine

    Drug: Promethazine

  • Experimental
    Hyoscine

    20 mg of hyoscine

    Drug: Hyoscine

Interventions

  • DrugHyoscine

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

  • DrugPromethazine

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

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What researchers measure

Primary outcomes

  1. Effect of Hyoscine and Promethazine on labor pain

    Time frame: up to 9 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01644838
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
Samira Ebrahimzadeh Zagami (School of Nursing & Midwifery, Mashhad University of Medical Sciences) — Principal investigator
First posted
Jul 19, 2012
Start date
Aug 2010
Primary completion
Mar 2011
Completion
Apr 2011
Last update
Jul 20, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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