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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT03055390
• Date of registration: 14/02/2017
• Prospective Registration: No
• Primary sponsor: Cairo University
• Public title: Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women
• Scientific title: Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women
• Date of first enrolment: February 11, 2017
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03055390
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: Ahmed Maged
• Affiliation: Kasr Alainy medical school

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Vaginal Delivery

Intervention(s)

Drug: placebo

Drug: hyoscine butylbromide

Primary Outcome(s)

Duration of the first stage of labour [Time Frame: 24 hours]

Secondary ID(s)

158

Source(s) of Monetary Support

Please refer to primary and secondary sponsors