NCT04443140

Brief Summary

By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

June 21, 2020

Last Update Submit

July 26, 2020

Conditions

Keywords

covıd-19pregnancypreeclampsiapreeclampsia-like syndrome

Outcome Measures

Primary Outcomes (1)

  • PCR positivity

    To detect Covid-19 PCR test positivity among preeclamptic pregnant women

    3 months

Interventions

PCR, lung ultrasoundDIAGNOSTIC_TEST

PCR for Covid-19

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females are studied.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19 pandemic

You may qualify if:

  • First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between March 15, 2020 and June 1, 2020.

You may not qualify if:

  • The pregnancies with known diagnosis of preeclampsia before Covid-19 pandemic
  • Preeclamptic patient without a Covid-19 PCR test result
  • Pregnant women who does not want to participate in study or does not want their personal informations to be shared
  • Pregnant women less than 18 years old and more than 40 years old are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Childrens Training and Research Hospital

Istanbul, 34660, Turkey (Türkiye)

Location

Related Publications (1)

  • Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.

MeSH Terms

Conditions

COVID-19Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Resul Karakus, MD

    Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 23, 2020

Study Start

March 15, 2020

Primary Completion

July 1, 2020

Study Completion

July 10, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations