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Clinical Trials/NCT03435965
NCT03435965
Unknown
Not Applicable

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Aljazeera Hospital2 sites in 1 country300 target enrollmentNovember 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PROM (Pregnancy)
Sponsor
Aljazeera Hospital
Enrollment
300
Locations
2
Primary Endpoint
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+
Last Updated
6 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
November 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Alalfy

Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

Aljazeera Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+

Time Frame: within a week

the accuracy of amnioQuick to diagnose PROM

Study Sites (2)

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