PROM by AmnioQuick Duo+ in Egyptian Women

August 4, 2019 updated by: Mahmoud Alalfy, Aljazeera Hospital

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
      • Giza, Egypt
        • Recruiting
        • Algazeerah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

- pregnant ladies with PROM from 20- 37 weeks came to the hospital to confirm PROM

Description

Inclusion Criteria:

  • pregnant ladies with PROM from 20- 37 weeks

Exclusion Criteria:

  • Gestational Age >37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PPROM from 20- less than 28 weeks
pregnant ladies with PROM from 20 - 28 weeks
Diagnostic test: AmnioQuickDuo+
AmnioQuickDuo+ kit for detection of PROM
PROM from more than 28 weeks - less than 37 weeks
pregnant ladies with PROM from more than 28- less than37 weeks
Diagnostic test: AmnioQuickDuo+
AmnioQuickDuo+ kit for detection of PROM
control group pregnant ladies in labour after 37 weeks
control group pregnant ladies in labour after 37 weeks with rupture of membrane in labour or in cs
Diagnostic test: AmnioQuickDuo+
AmnioQuickDuo+ kit for detection of PROM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+
Time Frame: within a week
the accuracy of amnioQuick to diagnose PROM
within a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Collaborators

Kasr El Aini Hospital
National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Anticipated)

October 15, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

February 10, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 4, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROM by AmnioQuick Duo+

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

the data will be shared after finishing the research

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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