NCT02103166

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

April 1, 2014

Last Update Submit

August 18, 2016

Conditions

Labor, First Stage

Outcome Measures

Primary Outcomes (1)

  • Time to complete dilation

    One hour

Study Arms (2)

Hyoscine bromide

EXPERIMENTAL

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

Drug: Hyoscine bromide

Physiological serum

PLACEBO COMPARATOR

100 ml of physiological serum (0.9% NaCl).

Drug: Physiological serum

Interventions

Hyoscine bromideDRUG

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

Also known as: Buscapina
Hyoscine bromide
Physiological serumDRUG

100 ml of physiological serum (0.9% NaCl).

Also known as: Saline serum
Physiological serum

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 or more.
  • Term pregnancy.
  • Cephalic presentation.
  • Uterine dynamic established.
  • Abscence of high risk factors or very high risk factors for pregnancy.
  • Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, Barcelona, 08036, Spain

Location

Study Officials

  • Montse Palacio, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Mariona Rius, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Ana Sandra Hernandez, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Irene Teixido, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Irene Vives, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Midwives Collaborative Group HCP

    Hospital Clínic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD.

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 3, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

ES(1)