The Effect of Hyoscine Butylbromide on Shortening of First and Second Stages of Labor

Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839213
• Other study ID #: HBL
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2016
• Last updated: July 18, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Assiut Medical School Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The management of normal labor is both an art and a science. For decades, health providers have worked to manage labor actively and safely, with the goal of shortening the duration of painful labor. Reduction of Cesarean sections and other fetal and maternal complications is also an important aspect of labor management.

The safety of active management of labor has been demonstrated by several prospective randomized clinical trials. A shorter duration of labor from admission to delivery has also been consistently reported in numerous studies of women treated with the active management protocol.Hyoscine butylbromide belongs to the parasympatholytic group of drugs and is a semisynthetic derivative of scopolamine. It is an effective antispasmodic drug without the untoward side effects of atropine. Hyoscine butylbromide is a quaternary ammonium compound and has peripheral anticholinergic action, but no central action as it does not cross the blood-brain barrier. Hyoscine butylbromide acts primarily by blocking the transmission of neural impulses in the intraneural parasympathetic ganglia of abdominal organs, apparently inhibiting cholinergic transmission in the synapses of the abdominal and pelvic parasympathetic ganglia, thus relieving spasms in the smooth muscles of gastrointestinal, biliary, urinary tract, and female genital organs, especially the cervico-uterine plexus, thus aiding cervical dilatation.

Spasmolytic drugs are frequently employed in delivery rooms to overcome cervical spasms and thus reduce the duration of labor.

Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals in the world. The mechanism by which it acts in the context of labor has not yet been elucidated, and evidence of its efficacy has been largely anecdotal.

Major studies have been carried out to evaluate the effects of the injectable or suppository form of Hyoscine butyl bromide on cervical dilatation; a majority of these studies demonstrated the efficacy of Hyoscine butyl bromide in augmenting labor. However, a few studies showed no effect of Hyoscine Butyl bromide on accelerating labor. In addition, some studies also used oxytocin in active management of labor, which would certainly affect the duration of labor and increase bias in the results. The specific objectives of this study will be to assess whether Hyoscine butyl bromide is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first and second stages of labor with or without labor augmentation. We also intended to determine whether the use of Hyoscine butyl bromide in the first and second stages of labor has any associated increases in complications, such as an increase in blood loss or the rate of cesarean deliveries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• All 18 -40 years.

• Singleton pregnancies.

• Vertex presentation.

• Term (gestational age between 37-41 weeks + 6 days).

• Spontaneous labor with either intact membranes or spontaneous rupture of membranes for less than 12 hours.

Exclusion Criteria:

• Previous uterine scarring including previous cesarean section.

• Cephalopelvic disproportion.

• Malpresentation.

• Antepartum hemorrhage.

• Multiple pregnancy.

• Induced delivery.

• Any medical disease.

• Prolonged premature rupture of the membrane (more than 12 hours).

• Epidural analgesia or receive any analgesic like pethidine.

• Pervious cervical cerclage.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor

Intervention

Drug:
• Hyoscine Butyl bromide

• Saline

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of first and second stages of labor		8 hours	Yes