NCT01804348

Brief Summary

Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 19, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 5, 2013

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

February 19, 2013

Last Update Submit

March 4, 2013

Conditions

PREMATURE RUPTURE OF MEMBRANES

Keywords

PROM

Outcome Measures

Primary Outcomes (1)

  • amniotic fluid leaks

    up to 12 hours

Study Arms (1)

AL-SENSE 1-Step

EXPERIMENTAL

a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.

Device: AL-SENSE 1-Step

Interventions

AL-SENSE 1-StepDEVICE

a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.

AL-SENSE 1-Step

Eligibility Criteria

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

You may qualify if:

  • AgE 18 years OR GREATER.
  • Subject who will sign the informed consent form.
  • Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).

You may not qualify if:

  • Subjects that have had sexual relations within the last 12 hours.
  • Subject is unable or unwilling to cooperate with study procedures.
  • Subject is currently participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, Israel

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jacob Bornstain, MD

    Western Galilee Hospital Nahariya, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

March 5, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

March 5, 2013

Record last verified: 2012-11

Locations

IL(1)