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

NCT03430362 | Completed DMC

• 1 other identifier: 25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolonged Labor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hyoscine group

ACTIVE COMPARATOR

7\. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose

Drug: Hyoscine N Butylbromide

Control group

PLACEBO COMPARATOR

Group B, will receive 2 ml of normal saline single intravenous dose

Drug: Normal Saline 0.9%

Interventions

Hyoscine N Butylbromide DRUG

7\. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose

Also known as: Buscopan

Hyoscine group

Normal Saline 0.9% DRUG

Group B, will receive 2 ml of normal saline single intravenous dose

Also known as: Saline

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33983512 DERIVED

MeSH Terms

Interventions

Butylscopolammonium Bromide; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmed Maged

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Group A will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after. Group B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 12, 2018
• Study Start: March 2, 2018
• Primary Completion: December 23, 2019
• Study Completion: February 16, 2020
• Last Updated: October 7, 2021

Record last verified: 2021-09

Locations

EG (1)