Best Cutoff Value of Lactate Concentration in Vaginal Flu... | NCT03463811

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2018Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Mar 7, 2018

First Submission Date that Met QC Criteria

Mar 12, 2018

First Posted Date

Mar 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2018

Last Update Posted Date

Mar 13, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mennatallah Mohamed Elnemr, Best Cutoff value of lactate concentration in vaginal fluid to predict time of spontaneous onset of labor in PPROM, Ain Shams UniversitySponsor-Investigator

Lead Sponsor

Mennatallah Mohamed ElnemrOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Study design: Prospective observational cohort

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactate concentration in vaginal fluid	Diagnostic Test	Lactate concentration in vaginal fluid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Khairy, prof	Ainshams university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams		Cairo			Egypt

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.