Effect of Hyoscine- Bromide on Duration of the First Stage of Labor

Ain Shams University

Status: Enrolling

Conditions: Labor

Treatments: Other: normal saline; Drug: hyoscine butylbromide

Study type: Interventional

Funder types: Other

Identifiers

NCT06056869

MS 503/2023

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

buscopan group

Active Comparator group

Description:

will receive 2 ml (40 mg) of hyoscine butylbromide

Treatment:

Drug: hyoscine butylbromide

control group

Placebo Comparator group

Description:

will receive 2 ml of normal saline

Treatment:

Other: normal saline