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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06056869
Other study ID # MS 503/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 27, 2023
Est. completion date April 2024

Study information

Verified date October 2023
Source Ain Shams University
Contact Maii Nawara, MD
Phone +201001848388
Email maii_nawara@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Spasmolytic drugs are frequently used in delivery rooms to overcome cervical spasms and thus reduce the duration of labor. The aim of this randomized double blind placebo controlled trial is to study the efficacy of hyoscine butylbromide (HBB) for shortening of the first stage of labor in primigravid women.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: 1. Primigravid women. 2. Singleton pregnancy. 3. Presenting by the vertex. 4. Gestational age between 37 and 42 weeks 5. In active phase of labor with a cervical dilatation between 4-5 cm, with either intact membranes or spontaneous rupture of membranes for less than 12 h Exclusion Criteria: 1. Previous uterine scarring. 2. Malpresentation. 3. Antepartum hemorrhage. 4. Labor induction 5. Contraindication to vaginal delivery. 6. Contraindication to hyoscine.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
hyoscine butylbromide
will be given during first stage of labor intravenously
Other:
normal saline
placebo

Locations

Country Name City State
Egypt Ain Shams University maternity hospital Cairo Cairo/???????

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary duration of first stage of labor duration 6 months
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