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

NCT ID: NCT02839213

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

Brief 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.

Conditions

Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A (Hyoscine Butyl bromide group)

The women will be given Hyoscine Butyl bromide

Group Type: ACTIVE_COMPARATOR

Hyoscine Butyl bromide

Intervention Type: DRUG

group B (Saline group)

The women will be given saline

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

Interventions

Hyoscine Butyl bromide

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Kamal Mohamed Zahran

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

HBL

Identifier Type: -

Identifier Source: org_study_id