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

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.

Study Overview

• Status: Recruiting
• Conditions: Labor
• Intervention / Treatment: Drug: hyoscine butylbromide; Other: normal saline

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maii Nawara, MD; Phone Number: +201001848388; Email: maii_nawara@hotmail.com

Study Locations

• Egypt
  • Cairo/القاهرة
    • Cairo, Cairo/القاهرة, Egypt
      • Recruiting
      • Ain Shams University Maternity Hospital
      • Contact: Maii Nawara, MD; Phone Number: +201001848388; Email: maii_nawara@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: buscopan group; will receive 2 ml (40 mg) of hyoscine butylbromide	Drug: hyoscine butylbromide; will be given during first stage of labor intravenously
Placebo Comparator: control group; will receive 2 ml of normal saline	Other: normal saline; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of first stage of labor	duration	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Maii Nawara, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: MS 503/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: will be available with principal investigator if required

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No