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

What Was Tested

In this not phased trial, researchers set out to test hCG (human chorionic gonadotropin).

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.

It had two arms (groups): Rupture of membranes group (active comparator) and Intact 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.

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.

The registry classes the interventions as diagnostic test.

More on the Plan

Beta subunit of human chorionic gonadotropin assay will be measured in the vaginal washing in two groups.

The first group are pregnant women in the second or third trimester.

These women have definite rupture of membranes diagnosed by visual leaking of the amniotic fluid from the cervix during speculum examination.

The second group are pregnant women with intact membranes.

Who Took Part

Enrollment: 100 actual participants took part.

It was open to women only aged from 17 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: presence of vaginal bleeding; presence of any obstetric emergency as cord prolapse.

How the Study Was Run

The set-up was non-randomized, parallel-group and double-blind.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

As a double-blind hCG (human chorionic gonadotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2017-04-10 with completion listed for 2017-06-29.

It ran at 1 site in Egypt.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Concentration of beta subunit of human chorionic gonadotropin.

It also tracked 1 secondary outcome, for example Presence or absence of positive qualitative pregnancy test.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of hCG (human chorionic gonadotropin) in 100 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.