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

Study Overview
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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.

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.

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

Conditions
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Prolonged Labor

Intervention / Treatment
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* Drug: Hyoscine N Butylbromide
* Drug: Normal Saline 0.9%


Participation Criteria
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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. Exclusion Criteria: History of cervical surgery. Mal-presentation and mal-positions. Hypersensitivity to Hyoscine. Contraindication for vaginal delivery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyoscine group<br>7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose | Drug: Hyoscine N Butylbromide<br>* 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose<br>* Other names: Buscopan;|
| Placebo Comparator: Control group<br>Group B, will receive 2 ml of normal saline single intravenous dose | Drug: Normal Saline 0.9%<br>* Group B, will receive 2 ml of normal saline single intravenous dose<br>* Other names: Saline;|

What is the study measuring?
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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 |