NCT04558996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

September 18, 2020

Last Update Submit

September 18, 2020

Conditions

Covid19Pregnancy ComplicationsPremature Rupture of MembraneAbruptio PlacentaePrelabor Rupture of MembranesStillbirth

Outcome Measures

Primary Outcomes (2)

  • MATERNAL COMPLICATIONS

    MATERNAL MORTALITY MORBIDITY

    1 year

  • NEONATAL INFECTION

    VERTICAL TRANSMISION

    1 year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puerta de Hierro University Hospital

Majadahonda, Madrid, 28290, Spain

RECRUITING

Related Publications (3)

  • Gracia-Perez-Bonfils A, Martinez-Perez O, Llurba E, Chandraharan E. Fetal heart rate changes on the cardiotocograph trace secondary to maternal COVID-19 infection. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:286-293. doi: 10.1016/j.ejogrb.2020.06.049. Epub 2020 Jul 2.

    PMID: 32645644BACKGROUND

  • Martinez-Perez O, Vouga M, Cruz Melguizo S, Forcen Acebal L, Panchaud A, Munoz-Chapuli M, Baud D. Association Between Mode of Delivery Among Pregnant Women With COVID-19 and Maternal and Neonatal Outcomes in Spain. JAMA. 2020 Jul 21;324(3):296-299. doi: 10.1001/jama.2020.10125.

    PMID: 32511673RESULT

  • Engels Calvo V, Cruz Melguizo S, Abascal-Saiz A, Forcen Acebal L, Sanchez-Migallon A, Pintado Recarte P, Cuenca Marin C, Marcos Puig B, Del Barrio Fernandez PG, Nieto Velasco O, de la Cruz Conty ML, Martinez-Perez O; Spanish Obstetric Emergency Group. Perinatal outcomes of pregnancies resulting from assisted reproduction technology in SARS-CoV-2-infected women: a prospective observational study. Fertil Steril. 2021 Sep;116(3):731-740. doi: 10.1016/j.fertnstert.2021.04.005. Epub 2021 Apr 12.

    PMID: 33972083DERIVED

MeSH Terms

Conditions

COVID-19Pregnancy ComplicationsFetal Membranes, Premature RuptureAbruptio PlacentaeStillbirth

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor ComplicationsPlacenta DiseasesFetal DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Oscar M Martinez Perez, Epidemiologist

    HUHPH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar M Martinez Perez, MD

CONTACT

600417307oscarmartinezgine@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetric senior consultant

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 22, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

ES(1)