Rapid Immunoassay Tests for the Detection of Ruptured Membranes

NCT02495441 | Unknown

• 1 other identifier: PROM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.

Conditions

Premature Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

• Number of participants that become positive for pre labor rupture of membranes by the immunological test kits.

  This will be assessed by the performing 4 immunological tests and clinical assessment. These test kits includes ROM Plus, ActimProm®, Amnioquick® and Amnisure. Outcomes of the immune tests will be compared against a gold stranded clinical assessment.

  up to 1 year

Study Arms (1)

Dribbling group

Any woman who presents with alleged leakage of amniotic fluid. They will under go rapid Immunoassay Tests for the Detection of PROM

Other: Use of Rapid Immunoassay Tests for the Detection of PROM

Interventions

Use of Rapid Immunoassay Tests for the Detection of PROM OTHER

After informed consent , both the ROM Plus®, ActimProm Amnioquick® Complete and AmniSure® bedside tests (without the use of a speculum) will be performed. The patient will then undergo the standard clinical assessment, which includes a sterile speculum exam (SSE). If either 1) amniotic fluid is seen leaking from the cervical os, or 2) if at least two of the following three clinical signs are present: visual pooling of fluid in the posterior fornix, positive nitrazine test, and microscopic evidence of ferning, then the patient will be considered positive for ROM. Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of IGFBP-1/AFP tests and Amnisure®.

Dribbling group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes the pregnant mothers presenting to the De Soysa Hospital for Women, Colombo with alleged leakage of amniotic fluid. This is an urban population with multiple ethical back grounds.

You may qualify if:

• Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment

You may not qualify if:

• Known placental previa
• Active vaginal bleeding

Sponsors & Collaborators

• De Soysa Hospital for Women: lead
• Clinical Innovations, LLC: collaborator

Study Sites (1)

De Soyza Hospital for Women

Colombo, Western Province, Sri Lanka

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hemantha Senanayake, MS, FRCOG

  Department of Obstetrics & Gynaecology Faculty of Medicine University of Colombo, Sri Lanka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hemantha Senanayake, MS, FRCOG

CONTACT

+94714762176; senanayakeh@gmail.com,

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 13, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 7, 2015

Record last verified: 2015-07

Locations

SR (1)