Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women

  • STATUS
    Recruiting
  • days left to enroll
    38
  • participants needed
    300
  • sponsor
    Cairo University
Updated on 12 September 2021

Summary

A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.

Patients were divided into three equal groups:

Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.

Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.

Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

Description

A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.

For each patient:

  1. Complete history was taking to exclude allergy to hyoscine butylbromide, medical disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease etc.) and any contraindication for vaginal delivery.
  2. General examination of the patients including (pulse, blood pressure, temperature).
  3. Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
  4. Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
  5. Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of liquor, site of placental attachment and fetal heart rate.

Patients were divided into three equal groups:

Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.

Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.

Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

Details
Condition Vaginal Delivery
Treatment Placebo, Hyoscine butylbromide
Clinical Study IdentifierNCT03055390
SponsorCairo University
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 18 - 35 years old
Primigravdae or multigravida
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
High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

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
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