Hyoscine Butylbromide Effect on Duration of Labor

Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial

To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.

Study Overview

• Status: Completed
• Conditions: Labor
• Intervention / Treatment: Drug: Hyoscine Butylbromide 20Mg/1mL Injection; Drug: Saline Solution

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama
    • Saint Thomas Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Low risk gestation between 37 and 41 6/7 weeks.
• Cephalic (vertex) presentation.
• Spontaneous labor in active phase (4 cms)

Exclusion Criteria:

• Premature rupture of membranes upon arrival at the Labor and Delivery Unit > 4 hours.
• Multiple order pregnancy.
• Stillbirth.
• Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyoscine Butylbromide 20Mg/1mL Injection; Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms).	Drug: Hyoscine Butylbromide 20Mg/1mL Injection; Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).
Placebo Comparator: Saline solution; Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms).	Drug: Saline Solution; Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of first stage of labor	Time measured from the moment the patient receive the allocated medication/placebo to complete dilation	24 hours
Rate of cervical dilation	Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of labor	Time measured from the moment the patient receive the allocated medication/placebo to delivery	24 hours
Fetal and neonatal complications	Number of adverse events (fetal or neonatal)	72 hours

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Collaborators: Sistema Nacional de Investigadores de Panamá
• Investigators: Study Director: Osvaldo Reyes, MD, Maternidad del Hospital Santo Tomás

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Hyoscine butylbromide; Duration of labor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: MHST2014-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No