Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Mat… (NCT04465474) | Clinical Trial Compass
UnknownNot Applicable
Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
China, Hong Kong, Spain3,000 participantsStarted 2020-05-01
Plain-language summary
The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.
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.
Objective 1: Seroconversion during pregnancy
Inclusion criteria:
* Pregnant women who attended for Down syndrome screening (DSS) at 11-13 weeks
* Had serum sample taken between 1 November 2019 and 1 June 2020 consented for stored serum for future research
* Intended to deliver at the booking hospital.
Objective 2: SARS-CoV-2 and pregnancy loss
Inclusion criteria:
•Pregnant women presenting with first and second trimester miscarriage in Hong Kong and Spain, as well as those with stillbirth during periods of 6 and 12 months, respectively.
Objective 3: Pregnancy course and perinatal outcome
Inclusion criteria:
•Pregnant women affected by COVID-19
Objective 4: Vertical transmission
Inclusion criteria:
•Pregnant women affected by COVID-19
Objective 5: Potential mechanisms for vertical transmission
Inclusion criteria:
•Pregnant women affected by COVID-19
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
1
Seroconversion during pregnancy - DSS1
Timeframe: At DSS1 (Around 11-13 weeks gestation)
2
Seroconversion during pregnancy - At delivery
Timeframe: At Delivery
3
Pregnancy loss
Timeframe: At pregnancy loss
4
Pregnancy course and perinatal outcome
Timeframe: From date of recruited until the date of delivery
5
Vertical transmission
Timeframe: At Newborn 0 hours of life, mother immediately after delivery
Potential mechanisms for vertical transmission 1) placental barrier, 2) immune response and 3) fetal damage of vertical transmission and mechanism in SARS-CoV-2 infection.
Timeframe: through study completion, up to 2 years