UnknownNot Applicable

Spanish Registry of Pregnant Women With COVID-19

Spain3,000 participantsStarted 2020-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MATERNAL COMPLICATIONS

Timeframe: 1 year

NEONATAL INFECTION

Timeframe: 1 year

Trial details

NCT IDNCT04558996

SponsorPuerta de Hierro University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

Contact for this trial

Oscar M Martinez Perez, MD

600417307 oscarmartinezgine@gmail.com

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