NCT03055390

Brief Summary

A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study. Patients were divided into three equal groups: Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo. Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously. Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

February 11, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

4.9 years

First QC Date

February 14, 2017

Last Update Submit

March 8, 2022

Conditions

Vaginal Delivery

Keywords

hyoscine butylbromideprogress of laborduration of labor

Outcome Measures

Primary Outcomes (1)

  • Duration of the first stage of labour

    Duration of the first stage of labour

    24 hours

Study Arms (3)

Control

PLACEBO COMPARATOR

They received two ml of normal saline intravenously as a placebo

Drug: placebo

20 mg hyoscine butylbromide

ACTIVE COMPARATOR

They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously

Drug: hyoscine butylbromide

40 mg hyoscine butylbromide

ACTIVE COMPARATOR

They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously

Drug: hyoscine butylbromide

Interventions

hyoscine butylbromideDRUG

Intravenous administration of hyoscine butylbromide during first stage of labor

Also known as: Dospa
20 mg hyoscine butylbromide40 mg hyoscine butylbromide
placeboDRUG

2ml of saline intravenous

Also known as: saline
Control

Eligibility Criteria

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

You may qualify if:

  • Age: 18 - 35 years old
  • Primigravdae or multigravida
  • Gestational age between completed 37- 41 weeks + 6 days.
  • Uncomplicated cephalic singleton pregnancy occipto-anterior position.
  • Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
  • Intact amniotic membranes.
  • High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

You may not qualify if:

  • Multigravidae.
  • Multiple fetus.
  • Malpresentation.
  • Patients with indications of elective caesarean section.
  • Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
  • Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
  • Patients presented to causality with spontaneous rupture of membranes.
  • Spontaneous rupture of membranes during the active phase of first stage of labour.
  • Oxytocin induction or augmentation.
  • Patients who underwent epidural anesthesia or other types of analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Butylscopolammonium Bromide2,3-dioleyloxy-N-(2-(sperminecarboxamido)ethyl)-N,N-dimethyl-1-propanaminium trifluoroacetateSodium Chloride

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ahmed Maged

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 16, 2017

Study Start

February 11, 2017

Primary Completion

January 10, 2022

Study Completion

February 3, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

EG(1)