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

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-03-31

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

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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

Conditions

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Vaginal Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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20mg hyoscine butylbromide

They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously

Group Type ACTIVE_COMPARATOR

hyoscine butylbromide

Intervention Type DRUG

20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

saline

Intervention Type DRUG

0.9%normal saline

40 mg hyoscine butylbromide

They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously

Group Type ACTIVE_COMPARATOR

hyoscine butylbromide

Intervention Type DRUG

20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

Saline

They received two ml of normal saline intravenously as a placebo

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

0.9%normal saline

Interventions

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hyoscine butylbromide

20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

Intervention Type DRUG

saline

0.9%normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 - 35 years old
2. Primigravdae.
3. Gestational age between completed 37- 41 weeks + 6 days.
4. Uncomplicated cephalic singleton pregnancy occipto-anterior position.
5. 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%.
6. Intact amniotic membranes.

Exclusion Criteria

1. Multigravidae.
2. Multiple fetus.
3. Malpresentation.
4. Patients with indications of elective caesarean section.
5. Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
6. Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
7. Patients presented to causality with spontaneous rupture of membranes.
8. Spontaneous rupture of membranes during the active phase of first stage of labour.
9. Oxytocin induction or augmentation.
10. Patients who underwent epidural anesthesia or other types of analgesia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No