Spanish Registry of Pregnant Women With COVID-19 (OBS COVID)
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|ClinicalTrials.gov Identifier: NCT04558996|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Study title Spanish Registry of Pregnant Women with COVID-19 Protocol number and version Number 55/20. Version V8. Sponsors This registry is a project promoted by Dr. Oscar Martínez Pérez of the Obstetrics and Gynaecology department of the Puerta de Hierro University Hospital.
Principal investigator of the registry National coordinator: Dr. Óscar Martínez Pérez. Obstetrics and Gynaecology Department. Puerta de Hierro University Hospital. Majadahonda.
Epidemiologist: Maria Luisa de la Cruz Conti Researchers for each site: 100 sites from 32 Spanish provinces are included (Appendix 1) Funding Neither the hospitals nor the participating investigators will receive any financial compensation for their collaboration. A bank account has been opened at the hospital's Biomedical Research Foundation to receive donations: COV20/00021 - SARS-COV-2 and the COVID-19 disease Call financed by the Carlos III Institute of Health and co-financed with ERDF funds.
Abstract Rationale: Knowledge about the impact of the SARS-CoV-2 virus on pregnancy is still scarce and all current recommendations are based on less than 100 cases published in the literature. To identify moderate effects (such as vertical transmission, obstetric morbidity, foetal death, maternal or neonatal death) and to allow accurate risk estimates, larger sample sizes than those currently available are required.
Methods: Prospective observational study of pregnant women in whom SARS-CoV-2 infection is suspected at any time during pregnancy with positive test results for SARS-CoV-2, in order to create a registry of baseline characteristics of the pregnant woman, aspects related to the course of pregnancy and delivery, and related to the new-born, with an observation period of up to 14 days after delivery. Subsequently, several phased studies will be conducted to help establish and monitor the set of measures to improve the care of pregnant women.
Discussion: The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.
|Condition or disease|
|Covid19 Pregnancy Complications Premature Rupture of Membrane Abruptio Placentae Prelabor Rupture of Membranes Stillbirth|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||REGISTRO EPIDEMIOLOGICO DE COVID 19 EN GESTANTES|
|Actual Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
OBS COVID 3
Objective/s The purpose of this study was to test if pregnant patients with COVID-19 have more obstetrical morbidity than those non-infected.
Design Longitudinal cohort case study to quantify the obstetrical and perinatal morbi-mortality throughout all hospitals in Spain with a universal, consecutive PCR based screening program.
Recruitment: 1st March 2020 to 30 September 2020. Spanish sites collected in Appendix 1.
OBS COVID 4
Substudy 4. Epidemiological prevalence study Objective/s Determine the prevalence of SARS_COV2 infection in Spanish pregnant women Design Cross-sectional study. The nQuery Advisor Release 7.0 software was used to calculate the sample size, based on the available data. As we do not have data on the prevalence of COVID-19, we set an expected percentage of 50% (a situation that maximizes the sample size) of asymptomatic women during delivery. We determined the sample size for a COVID-19 delivery prevalence study with an expected prevalence of 50%, a 95% confidence level and 5% accuracy, resulting in a sample size of 1056 pregnant women.
- MATERNAL COMPLICATIONS [ Time Frame: 1 year ]MATERNAL MORTALITY MORBIDITY
- NEONATAL INFECTION [ Time Frame: 1 year ]VERTICAL TRANSMISION
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558996
|Contact: Oscar M Martinez Perez, MDemail@example.com|
|Puerta de Hierro University Hospital||Recruiting|
|Majadahonda, Madrid, Spain, 28290|
|Contact: Oscar M Martinez Perez, MD 600417307 firstname.lastname@example.org|
|Sub-Investigator: Maria Luisa De la Cruz Conti, PhD|
|Principal Investigator:||Oscar M Martinez Perez, Epidemiologist||HUHPH|