NCT01644838

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

7 months

First QC Date

July 17, 2012

Last Update Submit

July 19, 2012

Conditions

Labor Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Effect of Hyoscine and Promethazine on labor pain

    up to 9 months

Study Arms (2)

Promethazine

EXPERIMENTAL

25 mg of promethazine

Drug: Promethazine

Hyoscine

EXPERIMENTAL

20 mg of hyoscine

Drug: Hyoscine

Interventions

HyoscineDRUG

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

Hyoscine
PromethazineDRUG

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

Promethazine

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Interventions

ScopolaminePromethazine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPropylaminesAminesPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Nursing & Midwifery

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

July 20, 2012

Record last verified: 2012-07