Effect of Hyoscine- Bromide on Duration of the First Stage of Labor

NCT06056869 | Unknown DMC

• 1 other identifier: MS 503/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Spasmolytic drugs are frequently used in delivery rooms to overcome cervical spasms and thus reduce the duration of labor. The aim of this randomized double blind placebo controlled trial is to study the efficacy of hyoscine butylbromide (HBB) for shortening of the first stage of labor in primigravid women.

Conditions

Labor

Outcome Measures

Primary Outcomes (1)

• duration of first stage of labor

  duration

  6 months

Study Arms (2)

buscopan group

ACTIVE COMPARATOR

will receive 2 ml (40 mg) of hyoscine butylbromide

Drug: hyoscine butylbromide

control group

PLACEBO COMPARATOR

will receive 2 ml of normal saline

Other: normal saline

Interventions

hyoscine butylbromide DRUG

will be given during first stage of labor intravenously

buscopan group

normal saline OTHER

placebo

control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primigravid women.
• Singleton pregnancy.
• Presenting by the vertex.
• Gestational age between 37 and 42 weeks
• In active phase of labor with a cervical dilatation between 4-5 cm, with either intact membranes or spontaneous rupture of membranes for less than 12 h

You may not qualify if:

• Previous uterine scarring.
• Malpresentation.
• Antepartum hemorrhage.
• Labor induction
• Contraindication to vaginal delivery.
• Contraindication to hyoscine.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University maternity hospital

Cairo, Cairo/القاهرة, Egypt

RECRUITING

MeSH Terms

Interventions

Butylscopolammonium Bromide; Saline Solution

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Maii Nawara

  Associate professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maii Nawara, MD

CONTACT

+201001848388; maii_nawara@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 27, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)