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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 23, 2019

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.

Interventions

  • Drug: Hyoscine N Butylbromide
    • 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose
  • Drug: Normal Saline 0.9%
    • Group B, will receive 2 ml of normal saline single intravenous dose

Arms, Groups and Cohorts

  • Active Comparator: Hyoscine group
    • 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose
  • Placebo Comparator: Control group
    • Group B, will receive 2 ml of normal saline single intravenous dose

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed M Maged, MD, professor – Cairo University
  • Overall Official(s)
    • Ahmed Maged, Principal Investigator, professor

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