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

Not Applicable

Recruiting

• Conditions: Labor
• Interventions: Other: normal saline; Drug: hyoscine butylbromide

• Registration Number: NCT06056869
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study Start: 2023-09-27
• Study First Posted: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	normal saline	will receive 2 ml of normal saline
buscopan group	hyoscine butylbromide	will receive 2 ml (40 mg) of hyoscine butylbromide

Primary Outcome Measures

Name	Time	Method
duration of first stage of labor	6 months	duration

Trial Locations

Locations (1)

Ain Shams University maternity hospital; 🇪🇬 Cairo, Cairo/القاهرة, Egypt