Vaginal Fluid Wash in Pre-labour Rupture of Membranes

NCT ID: NCT02111148

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2021-12-31

Brief Summary

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The investigators assess in this study the sensitivity of Urea and Creatinine and that of Nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes

Detailed Description

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The aim of this study is to compare the accuracy of measuring the urea and creatinine level versus that of nitrazine test in vaginal wash of pre-labour rupture of membranes patients.Each patient with rupture of membranes will be assessed clinically and then if not in labour , patients will be divided into 2 groups, 5ml saline will be injected in the vagina of each patient in every group then the vaginal wash will be collected in a test tube. Urea and creatinine group, biochemical tests for urea and creatinine in mIU/ml to detect their presence in the wash will be done. In Nitrazine group wash will be assessed by nitrazine paper showing bluish discoloration in rupture membranes. Sensitivity of each test in diagnosed rupture of membranes will be assessed.Which means how many patients in each test show positive results in case of diagnosed case.

Conditions

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Disorder of Amniotic Cavity and/or Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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urea and creatinine

urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally

Group Type ACTIVE_COMPARATOR

Urea and creatinine

Intervention Type PROCEDURE

the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.

Nitrazine

Biochemical description of Nitrazine in the vaginal wash

Group Type ACTIVE_COMPARATOR

Nitrazine

Intervention Type PROCEDURE

Nitrazine detection in vaginal wash

saline

5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture.

Group Type ACTIVE_COMPARATOR

5ml saline

Intervention Type DRUG

the vagina will be washed with 5ml saline and vaginal wash will be collected.

Interventions

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Urea and creatinine

the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.

Intervention Type PROCEDURE

Nitrazine

Nitrazine detection in vaginal wash

Intervention Type PROCEDURE

5ml saline

the vagina will be washed with 5ml saline and vaginal wash will be collected.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gestational age between 28 and 41 weeks
* Single intrauterine pregnancy
* History of gush of fluid
* Liquor detected on speculum examination

Exclusion Criteria

* Vaginal bleeding
* Patients in labour
* Contaminated samples
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Nesreen Abdel Fattah Abdullah Shehata

Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nesreen A Shehata, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

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Nesreen Abdel Fattah Abdullah Shehata

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nesreen A Shehata, MD

Role: CONTACT

00201024150605

Other Identifiers

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Beni-Suef 2

Identifier Type: -

Identifier Source: org_study_id

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