Coronavirus InfectionCOVID&PREGNCT04416373
COVID-19 and Pregnancy Outcomes
An observational study of Coronavirus Infection and Pregnancy Complications, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Coronavirus Infection, Pregnancy Complications, Vertical Transmission of Infectious Disease
- What is being tested?
- RT PCR SARS-CoV-2
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Mar 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant women infected with Sars-Cov-2 from 6 to 41 weeks.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Nova Medical School - UNL
Lisbon
Nadia Charepe, MSc, MD, 00351213184000, nadia.charepe@chlc.min-saude.pt
Alexandra Queirós, MD, 00351213184000, alexandra.queiros@nms.unl.pt
About this study
Official title: COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
Read the detailed description
This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study.
Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.
- Conditions
- Coronavirus Infection, Pregnancy Complications, Vertical Transmission of Infectious Disease, Breastfeeding, Neonatal Infection
- Being tested
- RT PCR SARS-CoV-2
- Medical subject headings
- Coronavirus Infections, Pregnancy Complications, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT PCR SARS-CoV-2Diagnostic test
Also called SARS-COV-2 Serologic test
Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 Neonatal Infection
Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
Measured: 7 days
Secondary outcomes (6)
Perinatal mortality
stillbirths and deaths in the first week of life
Measured: 35 weeks
ICU maternal admission
maternal ICU admission due to COVID-19
Measured: 35 weeks
5 minute Apgar Score < 7
Newborn 5 minute Apgar Score < 7
Measured: 1 day
Preterm labour
Delivery between 24 and 36 weeks
Measured: 35 weeks
PPROM
Preterm premature rupture of the membranes between 24 and 36 weeks
Measured: 35 weeks
Miscarriage
spontaneous pregnancy loss before 24 weeks
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start22 Mar 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416373
- Sponsor's protocol ID
- COVID&PREG
- Acronym
- COVID&PREG
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study
- ClinicalTrials.gov ID
- NCT04416373
- Acronym / sponsor ID
- COVID&PREG / COVID&PREG
- Conditions
- Coronavirus Infection, Pregnancy Complications, Vertical Transmission of Infectious Disease, Breastfeeding, Neonatal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
Detailed description
This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study.
Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women infected with Sars-Cov-2 from 6 to 41 weeks.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT PCR SARS-CoV-2Also: SARS-COV-2 Serologic testPositive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples | Diagnostic test | – |
Primary outcome
SARS-CoV-2 Neonatal Infection
Time frame: 7 days
Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
6 secondary outcomes
Perinatal mortality
Time frame: 35 weeks
ICU maternal admission
Time frame: 35 weeks
5 minute Apgar Score < 7
Time frame: 1 day
Preterm labour
Time frame: 35 weeks
PPROM
Time frame: 35 weeks
Miscarriage
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and Pregnancy Complications, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Charepe, MD,MSc (00351213184000, nadia.charepe@chlc.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 Neonatal Infection (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.