Clinical trial NCT01854073: Hyoscine Butyl Bromide for Management of Prolonged Labor
Official title: Use of Hyoscine Butyl Bromide for Management of Prolonged Labor in Nulliparous Women, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prolonged Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Armed Forces Hospitals, Southern Region, Saudi Arabia
First posted: 2013-05-15
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Caesarean section rate for failure to progress
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: Labor and delivery ward of Armed Forces Hospital, Southern Region.
state: Asir
Study officials:
affiliation: Ain Shams University
name: Mohamed Ellaithy, MD
role: PRINCIPAL_INVESTIGATOR
References: