Role of Hyoscine Bromide in Latent and Active Labor

Randomized, Masked, Placebo-controlled Clinical Trial to Evaluate the Effects of a Single Intravenous Dose of Hyoscine Bromide on the Duration and Pain in Latent and Active Labor

Status

Suspended

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103166

Enrollment

180

Registered

2014-04-03

Start date

2014-04-30

Completion date

2018-04-30

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, First Stage

Brief summary

The purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.

Interventions

DRUGHyoscine bromide

20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).

DRUGPhysiological serum

100 ml of physiological serum (0.9% NaCl).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: 18 or more. * Term pregnancy. * Cephalic presentation. * Oxytocin perfusion not present at the time of inclusion. * Uterine dynamic established. * Abscence of high risk factors or very high risk factors for pregnancy. * Written informed consent

Exclusion criteria

* Induction of labor. * Presence of risk factors. * Patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.

Design outcomes

Primary

Measure	Time frame
Time to complete dilation	One hour

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026