Effect Of Intravenous Hyoscine -N-Butyl Bromide In Management Of Prolonged Labor In Nulliparous

Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.

Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.

Study Overview

• Status: Completed
• Conditions: Prolonged Labor
• Intervention / Treatment: Drug: Hyoscine N Butylbromide; Drug: Normal Saline 0.9%

Detailed Description

Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.

Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• • Nulliparous women.

  • cervical dilatation in the active phase of less than 1.2 cm/h for nulliparous women
  • Gestational age ≥ 37 weeks.
  • Singleton pregnancy.
  • Vertex presentation.
  • Cervical dilatation ≥ 4cm.
  • No evidence of maternal or fetal distress.
  • Average size baby.

Exclusion Criteria:

• History of cervical surgery.
• Mal-presentation and mal-positions.
• Hypersensitivity to Hyoscine.
• Contraindication for vaginal delivery.

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
Active Comparator: Hyoscine group; 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose	Drug: Hyoscine N Butylbromide; 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose; Other Names: Buscopan
Placebo Comparator: Control group; Group B, will receive 2 ml of normal saline single intravenous dose	Drug: Normal Saline 0.9%; Group B, will receive 2 ml of normal saline single intravenous dose; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of active phase of first stage of labor	time elapsed between start of active phase till full cervical dilatation	8 hours after hyoscine adminstration

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Maged AM, Sorour EH, ElSadek MM, Hassan SM, Shoab AY. A randomized controlled study of the effect of hyoscine butylbromide on duration of labor in primigravida women with prolonged labor. Arch Gynecol Obstet. 2021 Dec;304(6):1513-1518. doi: 10.1007/s00404-021-06087-7. Epub 2021 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): February 16, 2020

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• 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: 25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No