Effect of Intravenous Hyoscine Butylbromide Injection on First Stage Labour in Primigavidae

Study Overview
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Brief Summary
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A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

Detailed Description
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A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

Official Title
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Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae

Conditions
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Vaginal Delivery

Intervention / Treatment
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* Drug: hyoscine butylbromide
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 - 35 years old Primigravdae. Gestational age between completed 37- 41 weeks + 6 days. Uncomplicated cephalic singleton pregnancy occipto-anterior position. Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%. Intact amniotic membranes. Exclusion Criteria: Multigravidae. Multiple fetus. Malpresentation. Patients with indications of elective caesarean section. Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus. Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma. Patients presented to causality with spontaneous rupture of membranes. Spontaneous rupture of membranes during the active phase of first stage of labour. Oxytocin induction or augmentation. Patients who underwent epidural anesthesia or other types of analgesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20mg hyoscine butylbromide<br>They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously | Drug: hyoscine butylbromide<br>* 20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor<br>Drug: saline<br>* 0.9%normal saline<br>|
| Active Comparator: 40 mg hyoscine butylbromide<br>They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously | Drug: hyoscine butylbromide<br>* 20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor<br>|
| Placebo Comparator: Saline<br>They received two ml of normal saline intravenously as a placebo | Drug: saline<br>* 0.9%normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first stage duration | time till cervix become fully dilated | 12 hours after drug intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Normal vaginal or cesarean section | 12 hours after drug intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal labour, Augmentation of labour, Hyoscine butylbromide