NCT03435965

PROM by AmnioQuick Duo+ in Egyptian Women

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Aljazeera Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• PROM (Pregnancy)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AmnioQuickDuo+	AmnioQuickDuo+ kit for detection of PROM

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-10-15
• Completion: 2019-11-01
• First posted: 2018-02-19
• Last updated: 2019-08-06

Locations

2 sites across 1 country: Egypt