PROM by AmnioQuick Duo+ in Egyptian Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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PROM (Pregnancy)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PPROM from 20- less than 28 weeks

pregnant ladies with PROM from 20 - 28 weeks

AmnioQuickDuo+

Intervention Type DIAGNOSTIC_TEST

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

AmnioQuickDuo+

Intervention Type DIAGNOSTIC_TEST

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

AmnioQuickDuo+

Intervention Type DIAGNOSTIC_TEST

AmnioQuickDuo+ kit for detection of PROM

Interventions

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AmnioQuickDuo+

AmnioQuickDuo+ kit for detection of PROM

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes