The HOPE study is looking at how environmental and biological factors affect healthy or adverse pregnancy and infant outcomes during the COVID-19 pandemic and afterwards. We are interested in what is happening in the lives of pregnant people with and without exposure to the COVID-19 virus.. The adverse outcomes we are looking at include:

in pregnant women and birthing persons:

• miscarriage or stillbirth
• preterm birth (before 37 completed weeks of gestation)
• preeclampsia or eclampsia (high blood pressure that is sometimes accompanied by protein in the urine and stroke)
• intrauterine growth restriction of the fetus
• placental abruption (early separation of the placenta from the uterus)
• placental previa (placental lying low in the uterus, which may cover cervix)
• placental accreta (placenta growing into uterine wall)
• gestational hypertension
• gestational diabetes
• chrioamnionitis (infection of the membranes that surround the fetus)
• oligo- or polyhydramnios (too little or too much amniotic fluid);

in infants:

• death
• illness requiring hospitalization
• structural or chromosomal birth defects
• diagnosed clinical disorders (for example, respiratory distress syndrome or difficulties with seeing or hearing)
• growth restriction/failure to gain weight or grow (sometimes called "failure to thrive")
• developmental delay.

Study surveys are filled out during each trimester of pregnancy (depending on the timing of enrollment) and at four times between 6 weeks and 18 months after a baby is born. Links to complete the surveys are sent by emal and participants can fill out these surveys on a cell phone or on a computer. The first survey takes about 45 minutes to complete and asks about health and pregnancy history and about background including about childhood experiences. Surveys also ask about how a participant is currently feeling and about any COVID-19-related illness the participant or any family member might be experiencing or might have experienced. Subsequent prenatal surveys take about 20 to 30 minutes to complete. These surveys focus on current health and well-being and also on COVID-19-related experiences.

Surveys compleated after birth also take about 20-30 minutes to complete and ask about labor and delivery, as well as about decisions and experiences with breastfeeding. Surveys after birth also ask about infant health and development. These surveys continue to ask about any COVID-19-related illness and experiences.

Participants in the survey+testing cohort also complete short surveys every week from enrollment through 6-8 weeks post-partum which ask about any new COVID-19 infections in the participant or family member, about any temperature measures at or above 100.4F, about any blood pressure measures at or above 120/80 mm, and about any pulse oximetry readings below 95%. These surveys take about 2 minutes to complete. Participants are encouraged to contact their health provider if at any time they or a family member has a positive COVID-19 test or if they have a fever at or above 100.4F, a blood pressure at or above 120/80 mm, or have a pulse oximetry reading below 95% (because these measurements could point to illness that will require additional medical attention). 

If you are unable to contact your provider and you have questions or concerns about your health or that of your baby, please contact HOPE study staff ([email protected]) who will work with study physicians to answer any questions you may have.  ​

Participants in the survey+testing cohort will also be asked to share access to their medical records and those of their infants during and after delivery so that study investigators can better understand participant and infant health and outcomes.

All information collected as part of the HOPE COVID-19 study is kept confidential and no identifying information for the pregnant person or baby (like name, address, date of birth, phone number, insurance, or medical provider ) are stored together with survey or molecular testing data. Participants are able to withdraw from the study at any time.

In partnerships with participants, study investigators are looking at patterns of COVID-19 infection during the pandemic and at how social, clinical, and biological factors may place some pregnant people and their babies at increased risk for adverse pregnancy and infant outcomes or help protect against adverse outcomes. Consideration of social, clinical, and biological factors also helps us identify areas where we may be able to intervene against risk or help build up health and resiliency through policy, neighborhood and community action, clinical treatment, and/or through the development of new therapies.

​Starting in Fall 2021, some HOPE study participants in the San Francisco Bay Area will be able to enroll in the survey+testing cohort which involves additional infection testing and biomolecular investigation for which they will receive additional compensation (see compensation section for more details on the types and amounts of compensation).

Specially, participants in the HOPE survey+testing cohort will:

• contribute biospecimens (e.g., nasal swabs and blood) between 15-20 weeks of pregnancy and at 6-8 weeks after birth;
• if giving birth at UCSF, contribute blood, umbilical cord blood, and placental tissue samples collected before and after delivery;
• opt-in to contribute additional specimens including: (1) nasal, oral, skin and vaginal swabs and a small stool sample at 15-20 weeks of pregnancy; (2) for those delivering at UCSF, vaginal swabs and first baby poop (meconium) samples after delivery; (3) at 6-8 weeks after birth, baby nasal, oral, and skin swabs, a baby poop sample, and a breastmilk sample.

Biospecimen collection and testing that is required as part of survey+testing cohort participation: Between 15-20 weeks of pregnancy, HOPE survey+testing cohort participants can schedule a licensed, fully vaccinated and protected laboratory professional to come to their home or place of work to collect nasal swab and blood samples. Or, if they prefer, participants can choose to visit the study partner facility in San Francisco (Protrero Hill) to have specimens collected. Materials for collecting finger stick blood samples and nasal samples used for COVID-19 and immune related testing at 6-8 weeks after delivery will be sent to participant homes and will be returned by mail.

Nasal specimens and testing for the COVID-19 related virus (SARS-CoV-2) during pregnancy: Participants in the survey+testing cohort will be tested for the COVID-19 related virus (SARS-CoV-2) between 15-20 weeks of pregnancy. Whether collected in the home or in the laboratory, visits will start with the swabbing of each nostril with nasal swabs included in the BinaxNOW SARS-CoV-2/COVID-19 test. Results of the test will be ready within 15 minutes and will be shared with participants during the visit, as well as resources for follow-up.​

• Positive results with be reported to the county of residence so that they can follow-up with the participant if needed (this reporting is required by state and local law); 
• A study physician will follow-up with any participant who has had a positive result in order to ensure they are receiving up-to-date health information and are getting any referrals that they may require or want;
• If a participant is found to have a positive result for SARS-CoV-2, the nasal sample will be used to sequence the SARS-CoV-2/ COVID-19 related virus to determine which variant of the virus (e.g., "delta") the participant is infected with. Sequencing of the COVID-19 related virus will be done several weeks to months after collection and are for research purposes only, and results will not be reported back to participants.

Nasal specimens and testing for the COVID-19 related virus (SARS-CoV-2) after delivery: Participants in the survey+testing cohort will also be asked to do a self-administered BinaxNOW SARS-CoV-2/ COVID-19 test between 6-8 weeks after birth. These materials will be mailed directly to the study participant.

• Participants will be asked to self-report the results using a survey that will be sent to them by email.
• Participants will be asked to return the kit result card in a study-provided bag that will go inside a pre-paid mailer that will be sent back to study personnel.
• Physician follow-up and reporting of positive tests will be the same as during pregnancy testing.

Blood collection and testing during pregnancy, during labor and delivery (for those delivering at UCSF), and after delivery: Participants in the survey+testing cohort will also be asked to contribute blood between 15-20 weeks of pregnancy. These specimens will be collected by laboratory personnel that visit participants in their homes or are collected at a testing facility if a participant prefers to have collection happen outside of their home. For participants that deliever at UCSF, maternal blood and umbilical cord blood specimens will also be collected.  After delivery, participants will also be asked to self-collect blood by finger stick at 6 to 8 week and use a pre-paid mailer to return their sample to study staff. These collection materials will be mailed directly to the study participant.

• Blood specimens will be tested for antibodies the body may have produced in response to being exposed to the COVID-19 related virus. Specimens will also be tested for the presence of other bacteria or viruses, as well as any inflammatory, immune, and metabolic markers that are produced in response to infection or are related to other health conditions.
• These blood tests will be done several weeks to months after collection and are for research purposes only. No results of these tests will be reported back to participants.

Placental sample collection for those delivering at UCSF. Participants in the survey+testing cohort who are planning to deliver at UCSF will also be asked to contribute a small placental sample.

• This sample will  be tested for the presence of other bacteria or viruses, as well as any inflammatory and immune markers that are produced in response to infection or are related to other health conditions.
• These placental tests will be done several weeks to months after collection and are for research purposes only. No results of these tests will be reported back to participants.

Baby urine. Participants in the survey+testing cohort will be asked to contribute a urine sample from their baby between 6-8 weeks after delivery. This sample will be collected at home and returned to study staff using a pre-paid mailer. 

• This sample will be tested for the presence of microbes and metabolic factors to help us better understand how different factors affect mom and baby health.
• These urine tests will be done several weeks to months after collection and are for research purposes only. No results of these tests will be reported back to participants.

Opt-in biospecimen collection and testing: Additional opt-in specimen collections between 15-20 weeks of pregnancy (for mothers) and at 6-8 weeks after delivery (for babies) will also be sent to participants for in-home collection. Participants will return samples to study staff using a pre-paid mailer. 

Mom and baby microbiome samples: Participants in the survey+testing cohort will be asked if they are willing to contribute additional specimens that will help investigators better understand what kinds of microbes (e.g., bacteria) live in the bodies of pregnant people and their babies. These microbes can influence healthy outcomes or increase risk for adverse outcomes. The patterns of these microbes is often referred to as a person's "microbiome." As part of the microbiome investigation, participants can choose to contribute none or all of the following:

• between 15-20 weeks of pregnancy: 
  • nasal swab 
  • skin swab 
  • oral swab
  • vaginal swab
  • a small stool sample 
• during labor and delivery (if delivering at UCSF): 
  • a vaginal swab
  • baby first poop (meconium)
• at 6-8 weeks after birth
  • baby nasal swab
  • baby skin swab 
  • baby oral swab
  • a small baby stool sample 

If a participant communicates their willingness to contribute one or more microbiome samples during the consenting process for any one of the collection periods:

• A microbiome study kit for 15-20 week second trimester collection will be included in the welcome kit that is mailed to each study participant. This includes a pre-paid mailer wherein participants can request a FedEx pick-up or use a FedEx dropbox.
• A microbiome study kit for labor and delivery will be shared with the labor and delivery team at UCSF. 
• A microbiome study kit for 6-8 week postnatal collection will be included in the baby welcome kit that is mailed to each study participant. This includes a pre-paid mailer wherein participants can request a FedEx pick-up or use a FedEx dropbox.

All microbiome testing will be done several weeks to months after collection and are for research purposes only, and results will not be reported back to participants. 

Breastmilk sample: Participants in the survey+testing cohort will be asked if they are willing to contribute breastmilk. If a participant communicates their willingness to contribute breastmilk during the consenting process, a breastmilk collection kit will be included in the baby welcome kit that is mailed to each study participant.

• Breastmilk will be tested for antibodies the body may have produced in response to being exposed to the COVID-19 related virus. These specimens will also be tested for the presence of other bacteria or viruses, as well as any inflammatory, immune, and metabolic markers that are produced in response to infection or are related to other health conditions.
• All breastmilk testing will be done several weeks to months after collection and are for research purposes only, and results will not be reported back to participants. 

In order to better understand maternal health during pregnancy and afterwards, survey+testing participants will be provided with a Fitbit Inspire 2 watch, a thermometer, a blood pressure monitor, and a pulse oximeter.  

Activity, heart rate and sleep patterns: Participants in the survey+testing cohort will be asked to wear a Fitbit Inspire 2 watch which will allow for the collection of information on heart rate, activity, and sleep (if the participant chooses to wear while sleeping).

• This watch will be included in the participant's welcome kit and is theirs to keep after study end.
• Participants directly control what the study team can and cannot see with respect to FitBit usage, and names and other identifying information are not associated with the watch. 

Temperature: Participants in the survey+testing cohort will be asked to regularly take their temperature (at least twice a week and if feeling unwell) using a study provided thermometer.. 

• A thermometer will be included in the participant's welcome kit and is theirs to keep after study end.
• Participants report the occurrence of any fevers at or above 100.4F and if they occur with or without a cough or sore throat via weekly check-in surveys sent by email. These surveys also capture if any person in their household has had a positive COVID-19 test.
• ​​If a participant experiences a fever at or above 100.4F, they are advised to contact their health provider as it could be suggestive of illness requiring medical follow-up. If you are unable to contact your provider and you have questions or concerns about your health or that of your baby, please contact HOPE study staff ([email protected]) who will work with study physicians to answer any questions you may have.  ​

Blood pressure: Participants in the survey+testing cohort will be asked to use an in-home blood pressure monitor and will be asked to take their blood pressure at least twice  a week. It is important that all participants (and all pregnant people) understand the importance of knowing their blood pressure during pregnancy.

• The study will provide participants with a blood pressure monitor at no cost. 
• Participants report the occurrence of any blood pressures at or above 120/80mm via weekly check in surveys sent by email. 
• ​​If a participant experiences a blood pressure measurement that is at or above 120/80 mm, they are advised to contact their health provider as this could be suggestive of illness requiring medical follow-up. If you are unable to contact your provider and you have questions or concerns about your health or that of your baby, please contact HOPE study staff ([email protected]) who will work with study physicians to answer any questions you may have.  ​

Pulse oximetry: Participants in the survey+testing cohort will be asked to use an in-home pulse oximetry measurement device and will be asked to take a measurement at least twice per week and if feeling unwell.

• The study will provide participants with a pulse oximeter at no cost
• Participants report the occurrence of a pulse oximetry measurement below 95% via weekly check in surveys sent by email. 
• ​If a participant experiences a pulse oximetry measurement below 95%, they are advised to contact their health provider as this could be suggestive of illness requiring medical follow-up. If you are unable to contact your provider and you have questions or concerns about your health or that of your baby, please contact HOPE study staff ([email protected]) who will work with study physicians to answer any questions you may have.  ​

Currently, you can enroll in the survey-only study cohort regardless of where you live or get care. 

PLEASE NOTE, the information below with respect to compensation ended with enrollments through October 2022. While compensation to participate in the study is not currently available, investigators are working to bring in grants and donations to allow this once again. 

Survey-Only Cohort - Compensation (enrollees through October 2022):

• There are no costs to participants.
• Participants living California who qualify for the study are able to request compensation for surveys submitted for each study time period in which they are enrolled.
• If participants qualify and have requested compensation, they can elect to receive $25 per survey per collection time period enrolled ($175 maximum). This includes up to seven study surveys including once during each trimester (depending on when they were enrolled), at 6-8 weeks after delivery, and at around their baby’s 6-month, 12-month and 18-month birthday.
• Compensation is by electronic gift card and will be sent within 10 business days of survey completion (generally sent within just a few days). To receive compensation this address must be in the specific geographies where compensation is allowed.
• If funding is secured to compensate study participants in other geographic areas, study investigators will notify participants living in those areas and ask if they would like to receive compensation for participation. All participants may be invited to enroll in other studies with compensation.
• Participants will receive quarterly newsletters about emerging research on COVID-19, pregnancy and infant health, and about study progress.
• Participants may be asked if they want to engage in an interview about study experience for which they would be compensated at a rate of $50/hour.

Survey+Testing Cohort - Compensation (enrollees through October 2022):

Women and birthing persons in the survey+testing cohort receive up to $400 in gift cards, a Fitbit watch, a thermometer, an in-home blood pressure monitor, and a pulse oximeter. Enrollment will begin with women and birthing persons receiving care in the San Francisco Bay Area including in the following counties: San Francisco, Marin, Contra Costa, Alameda, Santa Clara and San Mateo with expansion to other geographies across California, the US, and globally as other funds are identified.

• These participants can elect to receive $25 for each survey completed in the first, second, or third trimesters and at 6-8 weeks, 6-months, 12-months, and 18-months after birth ($175 total if enrolled in the first trimester and return all surveys).
• These participants can also elect to receive $50 after a biospecimen collection visit is complete between 15-20 weeks of pregnancy (done via in-home laboratory visit or by visiting the lab), $50 after they mail in their specimens 6-8 weeks postpartum. Participants can elect to receive an additional $25 for each microbiome collection kit returned (15-20 weeks of pregnancy and 6-8 weeks postpartum, $50 total). For participants delivering at UCSF, they can also elect to receive $50 for collection of blood (mom and umbilical cord), and a placental sample), and $25 for optional microbiome collections (a vaginal swab, first baby poop  (total compensation for biospecimen collections if all returned (where baby delivered at UCSF) = $225, $400 total if all surveys are returned and enrolled in the first trimester with complete biospecimen collections.
• Participants in this study arm also receive quarterly newsletters and may be asked if they want to engage in an interview about their study experience for which they would be compensated at a rate of $50/hour.