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

March 12, 2018 updated by: Mennatallah Mohamed Elnemr
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study design: Prospective observational cohort

Study Type

Observational

Enrollment (Anticipated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mennatallah Mohamed Elnemr

Investigators

  • Study Director: Ahmed Khairy, prof, AinShams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MElnemr

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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