Hyoscine Butyl Bromide for Management of Prolonged Labor

Prolonged Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01854073
• Other study ID #: AFHSR-5-2013
• Status: Recruiting
• Phase: Phase 3
• First received: May 11, 2013
• Last updated: March 9, 2017
• Start date: February 2014
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prolonged Labor

Intervention

Drug:
• Hyoscine butyl bromide

• Normal saline

Locations

Country	Name	City	State
Saudi Arabia	Labor and delivery ward of Armed Forces Hospital, Southern Region.	Khamis Mushait	Asir

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Armed Forces Hospital, Southern Region, Khamis Mushayt, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean section rate for failure to progress		6 hours