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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2020-02-16

Brief Summary

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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.

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Detailed Description

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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

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Prolonged Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hyoscine group

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

Group Type ACTIVE_COMPARATOR

Hyoscine N Butylbromide

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Normal Saline 0.9%

Intervention Type DRUG

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

Interventions

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Hyoscine N Butylbromide

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

Intervention Type DRUG

Normal Saline 0.9%

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

Intervention Type DRUG

Other Intervention Names

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Buscopan Saline

Eligibility Criteria

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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.