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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02839213
Other study ID # HBL
Secondary ID
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


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
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