ClinicalTrials.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has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Fetal Membranes, Premature Rupture · Egypt.

Started
2018
with 5 others
Observational
8 of 12
2 open now
Registered
5th of 12
by date
Lead sponsor
1 of 12
Aljazeera Hospital

Among the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt, this one is one of 6 that started in 2018, is one of 8 observational ones, and was the 5th registered.

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

Browse Fetal Membranes, Premature Rupture studies →

Open to participants now

2 of the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 12 Fetal Membranes, Premature Rupture studies recruiting now, 7 (58%) set no upper age limit and 5 (42%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 40 Years · female · healthy volunteers too.

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02

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

03

Conditions studied

  • PROM (Pregnancy)
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

2 of 2 sites recruiting
  • Kasralainy Hospital
    Cairo, Egypt
    Recruiting
  • Algazeerah
    Giza, Egypt
    Recruiting
    • Mahmoud Alalfy, master · Contactmahmoudalalfy@ymail.com · +201002611058
    • Ahmed Elgazzar, M.D · Contact+201014005959
    • Mahmoud Alalfy, master · Principal investigator
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2018 (actual). Primary completion is estimated for Oct 2019, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2018
First posted
Feb 19, 2018
StartActual
Nov 15, 2018
Primary completionEst.
Oct 15, 2019
CompletionEst.
Nov 1, 2019
Last update
Aug 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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