Using hyoscine butylbromide to shorten the first stage of labor
Effect of Hyoscine- Bromide on Duration of the First Stage of Labor
This study is testing if a medication called hyoscine butylbromide can help first-time pregnant women have a shorter first stage of labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo/القاهرة) |
| Trial ID | NCT06056869 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hyoscine butylbromide (HBB), a spasmolytic drug, in reducing the duration of the first stage of labor in first-time pregnant women. It is a randomized, double-blind, placebo-controlled trial where participants will receive either HBB or a placebo (normal saline) during active labor. The study focuses on women who are between 37 and 42 weeks of gestation and are experiencing cervical dilation of 4-5 cm. The goal is to determine if HBB can significantly shorten labor time compared to the placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are first-time pregnant women with singleton pregnancies who are in active labor.
Not a fit: Patients with previous uterine scarring, malpresentation, or contraindications to vaginal delivery or hyoscine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to shorter labor durations and improved delivery experiences for first-time mothers.
How similar studies have performed: While the use of spasmolytic drugs in labor is common, the specific efficacy of hyoscine butylbromide in this context has not been extensively studied, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo, Cairo/القاهرة
- Ain Shams University maternity hospital — Cairo, Cairo/القاهرة, Egypt (Recruiting)
Study contacts
- Principal investigator: Maii Nawara — Associate professor
- Study coordinator: Maii Nawara, MD
- Email: maii_nawara@hotmail.com
- Phone: +201001848388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.