PROM by AmnioQuick Duo+ in Egyptian Women

PROM (Pregnancy) Clinical Trial

Official title:

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03435965
• Other study ID #: PROM by AmnioQuick Duo+
• Status: Recruiting
• Start date: November 15, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: August 2019
• Source: Aljazeera Hospital
• Contact: Mahmoud Alalfy
• Phone: 01002611058
• Email: mahmoudalalfy[@]ymail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PROM (Pregnancy)

Intervention

Diagnostic Test:
• AmnioQuickDuo+
AmnioQuickDuo+ kit for detection of PROM

Locations

Country	Name	City	State
Egypt	Kasralainy Hospital	Cairo
Egypt	Algazeerah	Giza

Sponsors (3)

Lead Sponsor	Collaborator
Aljazeera Hospital	Kasr El Aini Hospital, National Research Center, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+	the accuracy of amnioQuick to diagnose PROM	within a week