ClinicalTrials.gg
Status unknownNCT03463811Updated Mar 13, 2018

Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM

An observational study in Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM, sponsored by Mennatallah Mohamed Elnemr. Status unknown at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Mennatallah Mohamed Elnemr · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Ages
25 Years to 35 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
6th of 12
by date
Lead sponsor
1 of 12
Mennatallah Mohamed Elnemr

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 6th 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: 25 Years to 35 Years · female.

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02

Study summary

The present study is aimed to assess whether lactate determination in vaginal fluid is associated with and can predict onset of labor for women with suspected preterm prelabor rupture of membranes (PPROMs).

Read the detailed description

Study design: Prospective observational cohort

03

Conditions studied

  • Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM
04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

This study will be conducted on 42 healthy pregnant with preterm PROM women they will be investigated for lactate concentration in vaginal fluid and observed for latency period till onset of spontaneous labor

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

  • Age 25-35 years old
  • 25-30
  • Singleton pregnancy in presentation with a history of suspected PPROM
  • A live fetus with gestational age between 26+0 weeks and 34+0 weeks

Exclusion criteria

Exclusion Criteria:

  • Abruption placenta
  • Medical disorders and hypertensive disorders of pregnancy
  • Intrauterine fetal death
  • Known or suspected fetal anomalies
  • Signs of infection (Fever, increase total leucocytic count)
  • Multiple pregnancy.
  • Regular uterine contractions.
  • History of cervical insufficiency
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testLactate concentration in vaginal fluid

    Lactate concentration in vaginal fluid

06

What researchers measure

Primary outcomes

  1. Time from examination to spontaneous onset of labor

    Time from examination to spontaneous onset of labor \< or \> 48 hours according to concentration of lactate in vaginal fluid

    Time frame: 48 hours

07

Study locations

1 site
  • Ain shams
    Cairo, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2018 (actual). Primary completion is estimated for Oct 2018, 8 months after the start.

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

Registered
Mar 7, 2018
First posted
Mar 13, 2018
StartActual
Feb 15, 2018
Primary completionEst.
Oct 2018
CompletionEst.
Nov 2018
Last update
Mar 13, 2018
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 Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03463811
Lead sponsor
Mennatallah Mohamed Elnemr
Responsible party
Mennatallah Mohamed Elnemr (Best Cutoff value of lactate concentration in vaginal fluid to predict time of spontaneous onset of labor in PPROM, Ain Shams University) — Sponsor-investigator
First posted
Mar 13, 2018
Start date
Feb 15, 2018
Primary completion
Oct 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Mar 13, 2018

Study contacts

Ahmed Khairy, prof
study director · Ainshams university

Oversight

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 Mar 2018. You cannot join it, but the record below documents what was studied.

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