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

NCT ID: NCT06056869

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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buscopan group

will receive 2 ml (40 mg) of hyoscine butylbromide

Group Type ACTIVE_COMPARATOR

hyoscine butylbromide

Intervention Type DRUG

will be given during first stage of labor intravenously

control group

will receive 2 ml of normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

placebo

Interventions

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hyoscine butylbromide

will be given during first stage of labor intravenously

Intervention Type DRUG

normal saline

placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maii Nawara

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

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Ain Shams University maternity hospital

Cairo, Cairo/القاهرة, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maii Nawara, MD

Role: CONTACT

+201001848388

Facility Contacts

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Maii Nawara, MD

Role: primary

+201001848388

Other Identifiers

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MS 503/2023

Identifier Type: -

Identifier Source: org_study_id

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