Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROMNCT03463811
Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM
An observational study of Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM, run by Mennatallah Mohamed Elnemr at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM
- What is being tested?
- Lactate concentration in vaginal fluid
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2018to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Adult
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
Who may be able to join
- Age 25-35 years old
- BMI 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lactate concentration in vaginal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate concentration in vaginal fluidDiagnostic test
Lactate concentration in vaginal fluid
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start15 Feb 2018
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mennatallah Mohamed Elnemr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mennatallah Mohamed Elnemr, Ain Shams University
- Investigators
- Ahmed Khairy, prof, Study director, Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463811
- Sponsor's protocol ID
- MElnemr
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM
- ClinicalTrials.gov ID
- NCT03463811
- Acronym / sponsor ID
- MElnemr
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mennatallah Mohamed ElnemrUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study design: Prospective observational cohort
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Age 25-35 years old
- BMI 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactate concentration in vaginal fluidLactate concentration in vaginal fluid | Diagnostic test | – |
Primary outcome
Time from examination to spontaneous onset of labor
Time frame: 48 hours
Time from examination to spontaneous onset of labor < or > 48 hours according to concentration of lactate in vaginal fluid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Khairy, prof study director
Ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aim is to Investigate Association Between Lactate Concentration in Vaginal Fluid and Time of Spontaneous Onset of Labor in PPROM, run by Mennatallah Mohamed Elnemr at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from examination to spontaneous onset of labor (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.