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

Vaginal Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824679
• Other study ID #: 150
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: March 2017

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Delivery

Intervention

Drug:
• hyoscine butylbromide
20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor
• saline
0.9%normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed M Maged, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first stage duration	time till cervix become fully dilated	12 hours after drug intake
Secondary	Mode of delivery	Normal vaginal or cesarean section	12 hours after drug intake