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Clinical Trials/NCT03435965
NCT03435965UnknownNot Applicable

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Aljazeera Hospital2 sites in 1 country300 target enrollmentStarted: November 15, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
2
Primary Endpoint
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+

Study 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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Alalfy

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

Aljazeera Hospital

Study Sites (2)

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