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

Vaginal Delivery Clinical Trial

Official title:

Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055390
• Other study ID #: 158
• Status: Completed
• Phase: Phase 4
• Start date: February 11, 2017
• Est. completion date: February 3, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 3, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age: 18 - 35 years old

2. Primigravdae or multigravida

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.

7. High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

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

Related Conditions & MeSH terms

• Vaginal Delivery

Intervention

Drug:
• hyoscine butylbromide
Intravenous administration of hyoscine butylbromide during first stage of labor
• placebo
2ml of saline intravenous

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the first stage of labour	Duration of the first stage of labour	24 hours