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PROM by AmnioQuick Duo+ in Egyptian Women

Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03435965
Enrollment
300
Registered
2018-02-19
Start date
2018-11-15
Completion date
2019-11-01
Last updated
2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PROM (Pregnancy)

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

Interventions

DIAGNOSTIC_TESTAmnioQuickDuo+

AmnioQuickDuo+ kit for detection of PROM

Sponsors

Kasr El Aini Hospital
CollaboratorOTHER
National Research Centre, Egypt
CollaboratorOTHER
Aljazeera Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+within a weekthe accuracy of amnioQuick to diagnose PROM

Countries

Egypt

Contacts

Primary ContactMahmoud Alalfy
mahmoudalalfy@ymail.com01002611058
Backup ContactAhmed Elgazzar
elgazzara50@gmail.com01014005959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026