NCT04558996: OBS COVID

Spanish Registry of Pregnant Women With COVID-19

Status unknown Last updated 22 September 2020

What this trial tests

trial in Covid19 in 3,000 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
31 December 2020

31 March 2021

Quick facts

Lead sponsor	Puerta de Hierro University Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	3,000
Start date	1 March 2020
Primary completion	31 December 2020
Estimated completion	31 March 2021
Sites	1 location across Spain

Conditions studied

• Covid19 — all drugs for Covid19 →
• Pregnancy Complications — all drugs for Pregnancy Complications →
• Premature Rupture of Membrane — all drugs for Premature Rupture of Membrane →
• Abruptio Placentae — all drugs for Abruptio Placentae →

Sponsor

Puerta de Hierro University Hospital

Who can join

18 and older, female only, with Covid19 or Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The association between SARS-CoV-2 infection and preterm delivery: a prospective study with a multivariable analysis.
   Martinez-Perez O, Prats Rodriguez P, Muner Hernandez M, Encinas Pardilla MB, et al · · 2021 · cited 58× · PMID 33794829 · DOI 10.1186/s12884-021-03742-4
2. Pregnancy Outcomes and SARS-CoV-2 Infection: The Spanish Obstetric Emergency Group Study.
   Cruz Melguizo S, de la Cruz Conty ML, Carmona Payán P, Abascal-Saiz A, et al · · 2021 · cited 39× · PMID 34067086 · DOI 10.3390/v13050853
3. Obstetric Outcomes of SARS-CoV-2 Infection in Asymptomatic Pregnant Women.
   Cruz-Lemini M, Ferriols Perez E, de la Cruz Conty ML, Caño Aguilar A, et al · · 2021 · cited 31× · PMID 33467629 · DOI 10.3390/v13010112
4. Perinatal outcomes of pregnancies resulting from assisted reproduction technology in SARS-CoV-2-infected women: a prospective observational study.
   Engels Calvo V, Cruz Melguizo S, Abascal-Saiz A, Forcén Acebal L, et al · · 2021 · cited 15× · PMID 33972083 · DOI 10.1016/j.fertnstert.2021.04.005
5. Impact of Recommended Maternal Vaccination Programs on the Clinical Presentation of SARS-CoV-2 Infection: A Prospective Observational Study.
   de la Cruz Conty ML, Encinas Pardilla MB, Garcia Sanchez M, Gonzalez Rodriguez L, et al · · 2021 · cited 11× · PMID 33429912 · DOI 10.3390/vaccines9010031
6. SARS-CoV-2 Infection and C-Section: A Prospective Observational Study.
   Morán Antolín E, Broullón Molanes JR, de la Cruz Conty ML, Encinas Pardilla MB, et al · · 2021 · cited 9× · PMID 34835136 · DOI 10.3390/v13112330
7. Critical Care in SARS-CoV-2 Infected Pregnant Women: A Prospective Multicenter Study.
   Álvarez Bartolomé A, Abdallah Kassab NA, Cruz Melguizo S, de la Cruz Conty ML, et al · · 2022 · cited 6× · PMID 35203683 · DOI 10.3390/biomedicines10020475
8. Association of ABO and Rh blood groups with obstetric outcomes in SARS-CoV-2 infected pregnancies: A prospective study with a multivariate analysis.
   Sainz Bueno JA, Cerrillos González L, Abascal-Saiz A, Rodríguez Gallego MV, et al · · 2021 · cited 5× · PMID 34271364 · DOI 10.1016/j.ejogrb.2021.07.008