Hyoscine Butyl Bromide for Management of Prolonged Labor

March 9, 2017 updated by: Mohamed Ellaithy, Ain Shams University

Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial

To determine the value of using Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Management of prolonged labor represents a challenging area in the daily obstetric practice. In 1993, Handa and Laros defined the arrest of active phase of labor, as failure of labor progress for 2 hours or more, and in 1994, WHO has proposed labor management partograph in which protraction is defined as < 1cm/hour cervical dilatation for a minimum of 4 hours.

Prolong labor increase the risks of maternal exhaustion, postpartum hemorrhage, sepsis, fetal distress and admission to the neonatal intensive care unit. The treatment of prolonged labor is highly desirable goal of intrapartum care, both from prospective of maternal and fetal wellbeing and for the provider of the birth services. Management of prolonged labor entails shorter exposure to pain, anxiety, and stress, and would thus translate into a major improvement in maternal satisfaction with child birth experience.

Several methods have been used for management of prolonged labor including amniotomy and oxytocin. Amniotomy can cause infection, and can be combined with oxytocin for better results while oxytocin can cause uterine hyper stimulation, water intoxication, vomiting, diarrhea, fetal distress, and neonatal jaundice.

Use of antispasmodics for reducing the duration of labor was first described in 1937 by Hirsch, who reported a decrease in labor length by two to four hours following intrapartum administration of an antispasmodic like drug (Syntropan®), mainly among older nulliparous, this was followed by many studies that investigated the role of antispasmodics in prevention of prolonged labor, however none of the these studies assessed the value of the antispasmodic for the treatment of prolonged labor; a recent Cochrane review advised that a rigorously designed well conducted randomized controlled trial with a large sample size would be beneficial to answer the question.

Hyoscine butyl bromide is spasmolytic drug that act by competitive antagonism to acetyl choline at post ganglionic parasympathetic nerve ending. It is claimed to reduce duration of labor by accelerating cervical dilatation without major side effects. It reduces the spasm of the smooth muscles. Although the efficacy of Hyoscine has been proven in various studies there is no clear evidence to recommend their routine use in management of prolonged labor.

The objective of the current study is to determine the use of Hyoscine as an antispasmodic drug for the management of prolonged labor in nulliparous women at term, managed according to a standard intrapartum protocol.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Asir
      • Khamis Mushait, Asir, Saudi Arabia, 101
        • Recruiting
        • Labor and delivery ward of Armed Forces Hospital, Southern Region.
        • Contact:
        • Principal Investigator:
          • Mohamed I Ellaithy, MD
        • Principal Investigator:
          • Nuzhat Amir
        • Principal Investigator:
          • Amel M Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous women.
  • Prolonged labor defined as no progress of labor for 2 hours or more.
  • Gestational age ≥ 37 weeks.
  • Singleton pregnancy.
  • Cephalic presentation.
  • Cervical dilatation ≥ 5 cm.
  • Intact fetal membranes.
  • No evidence of maternal or fetal distress.
  • Average size baby.

Exclusion Criteria:

  • Multigravid women.
  • Multifetal pregnancy.
  • History of cervical surgery.
  • Blood pressure > 150/90 mmHg.
  • Mal-presentation and mal-positions.
  • Hypersensitivity to Hyoscine.
  • Contraindication for vaginal delivery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Group A, will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after.
Drug: Hyoscine butyl bromide
Other Names:
  • Buscopan
Placebo Comparator: Group B
Group B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after.
Drug: Normal saline
Other Names:
  • Sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caesarean section rate for failure to progress
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Armed Forces Hospitals, Southern Region, Saudi Arabia

Investigators

  • Principal Investigator: Mohamed Ellaithy, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

May 11, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFHSR-5-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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