Covid-19IRCEPNCT04366986
International Registry of Coronavirus (COVID-19) Exposure in Pregnancy
An observational study of Covid-19, run by Pregistry at 1 site in United States.
Trial summary
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Covid-19
- What is being tested?
- Tested for SARS-CoV-2 (regardless of the result) and Clinical diagnosis of COVID-19 by a health care professional
- How many people
- 17,318 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 31 Aug 2021
- How long will I take part?
- 1 Year
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women, or women who have been pregnant in the last 6 months, who were tested for SARS-CoV-2 (regardless of the result) or were clinically diagnosed with COVID-19 by a health care professional.
Who may be able to join
- Pregnant women or women who have been pregnant within the last 6 months
- Able to give electronic informed consent
- Tested for SARS-CoV-2 (regardless of the result) or clinically diagnosed with COVID-19 by a health care professional
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.
Read the detailed description
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. As this is an international registry, women from all countries are welcome to participate.
Women will enroll and provide information to the IRCEP via website and mobile app. After signing the electronic informed consent document, registrants will answer questions on the following modules: Demographics, Reproductive History, Height and Weight, Habits, Health Conditions, Medications, Current Pregnancy, COVID-19 Infection Test, and COVID-19 Infection Symptoms. Monthly follow-up modules will continue until the pregnancy outcome. In case of a live birth, the Registry participant will continue with the Post-Partum Outcomes module until the newborn is 90 days of age. Medical records from the mother and neonate will also be requested.
- Conditions
- Covid-19
- Being tested
- Tested for SARS-CoV-2 (regardless of the result), Clinical diagnosis of COVID-19 by a health care professional
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested for SARS-CoV-2 (regardless of the result)Other
This is an observational study with no intervention
Clinical diagnosis of COVID-19 by a health care professionalOther
This is an observational study with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Women who are currently pregnant Receives: Other: Tested for SARS-CoV-2 (regardless of the result); Other: Clinical diagnosis of COVID-19 by a health care professional | |
| Post-partum women | Women who have been pregnant in the past 6 months Receives: Other: Tested for SARS-CoV-2 (regardless of the result); Other: Clinical diagnosis of COVID-19 by a health care professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcomes
Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery
Measured: 1 year
Birth outcomes
Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health
Measured: Birth to 90 days post-partum
Birth outcomes
Head circumference at birth in centimeters
Measured: Birth to 90 days post-partum
Birth outcomes
Length at birth in centimeters
Measured: Birth to 90 days post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start23 Jun 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- 17,318 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pregistry
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Diego Wyszynski, MD, MHS, PhD, Principal investigator, CEO Pregistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366986
- Sponsor's protocol ID
- 0001
- Acronym
- IRCEP
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
- ClinicalTrials.gov ID
- NCT04366986
- Acronym / sponsor ID
- IRCEP / 0001
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,318 participants (actual)
- Lead sponsor
- PregistryIndustry (pharma, biotech, devices)
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 Apr 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.
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.
Detailed description
The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. As this is an international registry, women from all countries are welcome to participate.
Women will enroll and provide information to the IRCEP via website and mobile app. After signing the electronic informed consent document, registrants will answer questions on the following modules: Demographics, Reproductive History, Height and Weight, Habits, Health Conditions, Medications, Current Pregnancy, COVID-19 Infection Test, and COVID-19 Infection Symptoms. Monthly follow-up modules will continue until the pregnancy outcome. In case of a live birth, the Registry participant will continue with the Post-Partum Outcomes module until the newborn is 90 days of age. Medical records from the mother and neonate will also be requested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: Tested for SARS-CoV-2 (regardless of the result), Other: Clinical diagnosis of COVID-19 by a health care professionalWomen who are currently pregnant |
| Post-partum women | – | Other: Tested for SARS-CoV-2 (regardless of the result), Other: Clinical diagnosis of COVID-19 by a health care professionalWomen who have been pregnant in the past 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women, or women who have been pregnant in the last 6 months, who were tested for SARS-CoV-2 (regardless of the result) or were clinically diagnosed with COVID-19 by a health care professional.
Key inclusion criteria (3 listed)
- Pregnant women or women who have been pregnant within the last 6 months
- Able to give electronic informed consent
- Tested for SARS-CoV-2 (regardless of the result) or clinically diagnosed with COVID-19 by a health care professional
Key exclusion criteria (1 listed)
- <18 years of age
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 |
|---|---|---|
| Tested for SARS-CoV-2 (regardless of the result)This is an observational study with no intervention | Other | Post-partum women, Pregnant Women |
| Clinical diagnosis of COVID-19 by a health care professionalThis is an observational study with no intervention | Other | Post-partum women, Pregnant Women |
Primary outcome
Pregnancy outcomes
Time frame: 1 year
Miscarriage (or spontaneous abortion), Elective termination, Stillbirth, Preterm delivery
Birth outcomes
Time frame: Birth to 90 days post-partum
Major structural defects, neonatal death, Admission into the Neonatal Intensive Care Unit, Maternal obstetric complications, Post-partum health
Birth outcomes
Time frame: Birth to 90 days post-partum
Head circumference at birth in centimeters
Birth outcomes
Time frame: Birth to 90 days post-partum
Length at birth in centimeters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- International Registry of Coronavirus (COVID-19) Exposure in PregnancyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Diego Wyszynski, MD, MHS, PhD principal investigator
CEO Pregistry
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 Covid-19, run by Pregistry at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 28 Sep 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcomes (time frame: 1 year). The study lists 4 primary outcomes in all. 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 28 Sep 2021.