PROM by AmnioQuick Duo+ in Egyptian Women

A

Aljazeera Hospital

Status

Unknown

Conditions

PROM (Pregnancy)

Treatments

Diagnostic Test: AmnioQuickDuo+

Study type

Observational

Funder types

Other

Identifiers

NCT03435965
PROM by AmnioQuick Duo+

Details and patient eligibility

About

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.

Full 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

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

PPROM from 20- less than 28 weeks
Description:
pregnant ladies with PROM from 20 - 28 weeks
Treatment:
Diagnostic Test: AmnioQuickDuo+
PROM from more than 28 weeks - less than 37 weeks
Description:
pregnant ladies with PROM from more than 28- less than37 weeks
Treatment:
Diagnostic Test: AmnioQuickDuo+
control group pregnant ladies in labour after 37 weeks
Description:
control group pregnant ladies in labour after 37 weeks with rupture of membrane in labour or in cs
Treatment:
Diagnostic Test: AmnioQuickDuo+

Trial contacts and locations

2

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Central trial contact

Mahmoud Alalfy; Ahmed Elgazzar

Data sourced from clinicaltrials.gov

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