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Spanish Registry of Pregnant Women With COVID-19 (OBS COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558996
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Hospital Universitario La Fe
Information provided by (Responsible Party):
Oscar Martinez Perez, Puerta de Hierro University Hospital

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.

  • Determine the variables that are associated with more maternal and neonatal morbidity.
  • Quantify the risk of adverse pregnancy outcomes (e.g., miscarriage, stillbirth, growth restriction) and neonatal outcomes (e.g., NICU, prematurity, death, birth defects).

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.



Primary Outcome Measures :
  1. MATERNAL COMPLICATIONS [ Time Frame: 1 year ]
    MATERNAL MORTALITY MORBIDITY

  2. NEONATAL INFECTION [ Time Frame: 1 year ]
    VERTICAL TRANSMISION



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
For the characterization of the clinical course of SARS-CoV-2 infection during pregnancy, the pre-study sample size calculation has not been carried out, as registry-based studies generally tend to be comprehensive without involving hypotheses.
Criteria

Inclusion Criteria:

-

Patients eligible for follow-up o target population will be any pregnant woman who is suspected or needs to be ruled out as having a SARS-CoV-2 infection at any time during pregnancy with positive test results for SARS-CoV-2 by PCR.

Information regarding each pregnant woman's demographic characteristics, comorbidities and current obstetric history was extracted from the medical history and the patient interview; subsequently, age and race were categorized according to the classification used by the Center for Disease Control and Prevention (CDC) (17).

For the selection of the control group to be collected in the same database, patients with a negative COVID-19 delivery diagnosed by PCR screening at delivery, or less than 3 days before, were considered.

Exclusion criteria

Pregnant women under the following conditions will be excluded from the registry:

  • Inability to give informed consent in the absence of a legal representative.
  • If, in the opinion of the researcher, findings in the physical examination, anomalies in the results of the laboratory tests or other medical, social or psychosocial factors could have a negative influence.
  • Loss of follow-up data prior to 6 weeks postpartum.

Information from the National Library of Medicine

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


Contacts
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Contact: Oscar M Martinez Perez, MD 600417307 oscarmartinezgine@gmail.com

Locations
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Spain
Puerta de Hierro University Hospital Recruiting
Majadahonda, Madrid, Spain, 28290
Contact: Oscar M Martinez Perez, MD    600417307    oscarmartinezgine@gmail.com   
Sub-Investigator: Maria Luisa De la Cruz Conti, PhD         
Sponsors and Collaborators
Puerta de Hierro University Hospital
Hospital Universitario La Paz
Hospital Universitario 12 de Octubre
Hospital General Universitario Gregorio Marañon
Hospital Universitario La Fe
Investigators
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Principal Investigator: Oscar M Martinez Perez, Epidemiologist HUHPH
Publications of Results:
Other Publications:
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Responsible Party: Oscar Martinez Perez, Obstetric senior consultant, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT04558996    
Other Study ID Numbers: 55/20
COV20/0021 ( Other Grant/Funding Number: CARLOS III INSTITUTE )
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications
Fetal Membranes, Premature Rupture
Stillbirth
Abruptio Placentae
Rupture
Wounds and Injuries
Obstetric Labor Complications
Fetal Death
Death
Pathologic Processes
Placenta Diseases