CClinicalTrials.gg
Status unknownNCT03435965Updated Aug 6, 2019

PROM by AmnioQuick Duo+ in Egyptian Women

An observational study in PROM (Pregnancy), sponsored by Aljazeera Hospital. Status unknown at 2 sites in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Aljazeera Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the 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

02

Conditions studied

  • PROM (Pregnancy)
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

  • pregnant ladies with PROM from 20- 37 weeks came to the hospital to confirm PROM

Inclusion criteria

  • pregnant ladies with PROM from 20- 37 weeks

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • PPROM from 20- less than 28 weeks

    pregnant ladies with PROM from 20 - 28 weeks

    Diagnostic Test: AmnioQuickDuo+

  • PROM from more than 28 weeks - less than 37 weeks

    pregnant ladies with PROM from more than 28- less than37 weeks

    Diagnostic Test: AmnioQuickDuo+

  • control group pregnant ladies in labour after 37 weeks

    control group pregnant ladies in labour after 37 weeks with rupture of membrane in labour or in cs

    Diagnostic Test: AmnioQuickDuo+

Interventions

  • Diagnostic testAmnioQuickDuo+

    AmnioQuickDuo+ kit for detection of PROM

05

What researchers measure

Primary outcomes

  1. number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+

    the accuracy of amnioQuick to diagnose PROM

    Time frame: within a week

06

Study locations

2 of 2 sites recruiting
  • Kasralainy Hospital
    Cairo, Egypt
    Recruiting
  • Algazeerah
    Giza, Egypt
    • Mahmoud Alalfy, master · Contact · mahmoudalalfy@ymail.com · +201002611058
    • Ahmed Elgazzar, M.D · Contact · +201014005959
    • Mahmoud Alalfy, master · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — the data will be shared after finishing the research

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03435965
Lead sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital, National Research Centre, Egypt
Responsible party
Mahmoud Alalfy (Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera Hospital) — Principal investigator
First posted
Feb 19, 2018
Start date
Nov 15, 2018
Primary completion
Oct 15, 2019 (estimated)
Completion
Nov 1, 2019 (estimated)
Last update
Aug 6, 2019

Study contacts

Mahmoud Alalfy
Contact
mahmoudalalfy@ymail.com
01002611058
Ahmed Elgazzar
Contact
elgazzara50@gmail.com
01014005959
Mahmoud Alalfy
principal investigator · Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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