Clinical trial

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

Name

MS 503/2023

Description

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.

Trial arms

Trial start

2023-09-27

Estimated PCD

2024-04-01

Trial end

2024-04-01

Status

Recruiting

Treatment

hyoscine butylbromide

will be given during first stage of labor intravenously

Arms:

buscopan group

normal saline

placebo

Arms:

control group

Size

Primary endpoint

duration of first stage of labor

6 months

Eligibility criteria

Inclusion Criteria: 1. Primigravid women. 2. Singleton pregnancy. 3. Presenting by the vertex. 4. Gestational age between 37 and 42 weeks 5. 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 Exclusion Criteria: 1. Previous uterine scarring. 2. Malpresentation. 3. Antepartum hemorrhage. 4. Labor induction 5. Contraindication to vaginal delivery. 6. Contraindication to hyoscine.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-10-06

1 organization

1 product

1 indication

Organization

Ain Shams University

Product

Hyoscine Butylbromide

Indication

Labour