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

Not Applicable

Completed

• Conditions: Prolonged Labor
• Interventions: Drug: Hyoscine N Butylbromide; Drug: Normal Saline 0.9%

• Registration Number: NCT03430362
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-12
• Study Start: 2018-03-02
• Primary Completion: 2019-12-23
• Study Completion: 2020-02-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt