PROM by AmnioQuick Duo+ in Egyptian Women
Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+
1 other identifier
observational
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedAugust 6, 2019
August 1, 2019
11 months
February 10, 2018
August 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+
the accuracy of amnioQuick to diagnose PROM
within a week
Study Arms (3)
PPROM from 20- less than 28 weeks
pregnant ladies with PROM from 20 - 28 weeks
PROM from more than 28 weeks - less than 37 weeks
pregnant ladies with PROM from more than 28- less than37 weeks
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
Interventions
AmnioQuickDuo+ kit for detection of PROM
Eligibility Criteria
\- pregnant ladies with PROM from 20- 37 weeks came to the hospital to confirm PROM
You may qualify if:
- pregnant ladies with PROM from 20- 37 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aljazeera Hospitallead
- Kasr El Aini Hospitalcollaborator
- National Research Centre, Egyptcollaborator
Study Sites (2)
Kasralainy Hospital
Cairo, Egypt
Algazeerah
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Alalfy
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital
Study Record Dates
First Submitted
February 10, 2018
First Posted
February 19, 2018
Study Start
November 15, 2018
Primary Completion
October 15, 2019
Study Completion
November 1, 2019
Last Updated
August 6, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
the data will be shared after finishing the research