Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture

July 10, 2017 updated by: rasha medhat abdul-hady, Ain Shams University
This study aims to investigate the relation between the concentration of urea and creatinine in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks gestation.

Study Overview

Status

Unknown

Conditions

Detailed Description

60 pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks History taking followed by examination All women will be put in dorsal lithotomy position, using a proper light source and sterile gloves; sterile speculum free of gel will be placed into vagina.

For every woman a specimen of vaginal fluid will be taken as follows: 5 ml of sterile saline solution will be injected into the posterior vaginal fornix taken after aspiration of 3ml with the same syringe.

All samples will be obtained within 6 hours after membranes rupture before vaginal examination and the administration of any drugs. Upon collection, samples were centrifuged at 3000 rpm for 10 minutes and supernatant fluid was separated. Exact concentrations of urea and creatinine will be measured

All women will be put under observation for 48 hours and time of onset of delivery will be documented, the onset of labor will be diagnosed by either:

  1. Frequent uterine contractions more than 2 contractions in 10 minutes.
  2. CTG showing frequent contractions.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, +20
        • Recruiting
        • Ain Shams University
        • Contact:

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

sixity pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks by reliable menstrual history and confirmed by pelvi-abdominal ultrasound.

Membranes rupture will be diagnosed by the direct visualization of fluid leakage from the cervical canal using sterile speculum.

Description

Inclusion Criteria:

  1. Maternal age between 20-35 years.
  2. 32-35 weeks gestational age.
  3. Viable fetus.

Exclusion Criteria:

  1. Vaginal bleeding either spontaneous or traumatic e.g. placenta previa.
  2. Chorioamnionitis.
  3. Multiple pregnancy.
  4. Presence of uterine contractions.
  5. Amniotic fluid disorders e.g. polyhydramnios
  6. Meconium stained amniotic fluid prior to active phase of labor.
  7. Maternal disease necessitating termination of pregnancy e.g. severe preeclampsia

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
delivery interval in Premature rupture of membranes
Time Frame: 48 hours
The time needed from the onset of PROM till time of onset of labour
48 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: rasha M Medhat Abd El-Hady, MD, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2017

Primary Completion (Anticipated)

July 10, 2017

Study Completion (Anticipated)

July 10, 2017

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

July 8, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP-PROM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Rupture of Membranes; Premature

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe