The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes

NCT03106311 | Completed

• 1 other identifier: 4567
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Two groups will be recruited. The first group are pregnant ladies that have unequivocal rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the vagina. The second group are normal pregnant ladies without rupture of membranes. both groups will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests will be measured in this fluid.

Conditions

Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• Concentration of beta subunit of human chorionic gonadotropin

  Concentration of beta subunit of human chorionic gonadotropin will be measured in vaginal washing fluid. The collection of vaginal washing fluid will be done by an investigator

  This outcome will be measured within 20 minutes of collection of vaginal washing fluid. The collection of vaginal washing fluid will be done by an investigator upon admission to the department of Obstetrics

Secondary Outcomes (1)

• Presence or absence of positive qualitative pregnancy test

  Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department.

Study Arms (2)

Rupture of membranes group

ACTIVE COMPARATOR

Pregnant women with definite rupture of membranes will undergo speculum examination. Vaginal washing will be done. The washing fluid will be taken for quantitative and qualitative assessment of beta subunit of human chorionic gonadotropin.

Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin

Intact membranes group

ACTIVE COMPARATOR

Pregnant women with intact membranes will undergo speculum examination. Vaginal washing will be done. The washing fluid will be taken for quantitative and qualitative assessment of beta subunit of human chorionic gonadotropin.

Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin

Interventions

assessment of beta subunit of human chorionic gonadotropin DIAGNOSTIC_TEST

Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin

Intact membranes group; Rupture of membranes group

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women between 14 and 40 weeks gestation with history of gush of vaginal fluid
• Pregnant women between without history of gush of vaginal fluid

You may not qualify if:

• Presence of vaginal bleeding
• Presence of any obstetric emergency as cord prolapse

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eman Omran, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: April 10, 2017
• Primary Completion: June 29, 2017
• Study Completion: July 7, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

EG (1)