PROM by AmnioQuick Duo+ in Egyptian Women

• Conditions: PROM (Pregnancy)
• Interventions: Diagnostic Test: AmnioQuickDuo+

• Registration Number: NCT03435965
• Lead Sponsor: Aljazeera Hospital

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 Timeline

• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-10
• Study First Posted: 2018-02-19
• Study Start: 2018-11-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-04
• Last Update Posted: 2019-08-06
• Primary Completion: 2019-10-15
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+	within a week	the accuracy of amnioQuick to diagnose PROM

Trial Locations

Locations (2)

Algazeerah; 🇪🇬 Giza, Egypt

Kasralainy Hospital; 🇪🇬 Cairo, Egypt