Prevalence of SARS-CoV-2 in pregnancy in Franconia (SCENARIO)

For this prospective observational study, 2.400 pregnant women of all weeks of pregnancy are recruited at nine study centres in the German region of Franconia. At baseline, general and pregnancy-associated diseases, history and prevalent COVID-19-typical symptoms and previous testing for SARS-CoV-2 infection are recorded. Nasopharyngeal swabs are collected for the determination of SARS-CoV-2 viral RNA as well as a blood sample for the evaluation of IgG antibody status by anti-SARS-CoV-2 ELISA. The primary outcome parameter is the rate of seropositive pregnancies in each of the three consecutive time cohorts. Secondary outcome parameters include prenatal, peripartum and postpartum maternal and neonatal morbidity.

Study Overview

Study name	Prevalence of SARS-CoV-2 in pregnancy in Franconia (SCENARIO)
Project	SCENARIO
Sources of Monetary or Material Support	Institutional budget, no external funding (budget of sponsor/PI)
Region(s)	Germany
Location(s)	Erlangen
Primary outcome	Rate of seropositive pregnancies in each of the three consecutive time cohorts
Research Question	Seroprevalence of SARS-CoV-2 in pregnancy
Diagnostic test(s) used	anti-SARS-CoV-2-NCP-ELISA (IgG) and anti-SARS-CoV-2-S1-ELISA (IgG) , EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Study population N	2400
Principal Investigator	PD Dr. med. Alexander Hein , Department of Gynaecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany , alexander.hein@uk-erlangen.de
WWW	www.covid19scenario.de
Period	2020-06 till 2021-01
Study start	2020-06
First results expected	2021-01

Study metadata

{
   "abbreviation": "SCENARIO",
   "draft": false,
   "iscjklanguage": false,
   "lastmod": "2021-03-12T11:24:20+01:00",
   "logo_url": "/img/uploads/scenario_pic2.png",
   "project_url": "www.covid19scenario.de",
   "recruitment": {
     "country": [
       "Germany"
     ],
     "group": "others",
     "location": [
       {
         "latitude": 49.5979983,
         "longitude": 11.0091564,
         "place_name": "Erlangen"
       }
     ],
     "type": "exploratory population-based cohort study"
   },
   "study_dates": {
     "sample_end": "2021-01",
     "sample_start": "2020-06",
     "study_first_results": "2021-01",
     "study_start": "2020-06"
   },
   "study_info": {
     "diagnostic_test": [
       {
         "address": "Germany",
         "antibody_classes": [
           "IgG"
         ],
         "company": "EUROIMMUN Medizinische Labordiagnostika AG",
         "product": "anti-SARS-CoV-2-NCP-ELISA (IgG) and anti-SARS-CoV-2-S1-ELISA (IgG)"
       }
     ],
     "funding_sources": "Institutional budget, no external funding (budget of sponsor/PI)",
     "primary_outcomes": "Rate of seropositive pregnancies in each of the three consecutive time cohorts",
     "research_question": "Seroprevalence of SARS-CoV-2 in pregnancy",
     "tested_antibody_classes": null
   },
   "study_numbers": {
     "study_population": 2400
   },
   "study_pi": {
     "email": "alexander.hein@uk-erlangen.de",
     "institution": "Department of Gynaecology and Obstetrics, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany",
     "name": "PD Dr. med. Alexander Hein"
   },
   "title": "Prevalence of SARS-CoV-2 in pregnancy in Franconia (SCENARIO)"
 }