PregnancyPregSourceNCT02577536
PregSource: Crowdsourcing to Understand Pregnancy
An observational study of Pregnancy and Pregnancy Complications, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
PregSource uses a crowd-sourcing approach, asking pregnant women to enter information regularly and directly about their pregnancies throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Pregnancy Complications, Morning Sickness
- How many people
- 2,359 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 31 Aug 2023
- How long will I take part?
- 6 Months
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnancy women 18 years of age or older.
Who may be able to join
- Women who are pregnant
Who cannot join
- Males
- Women who are not pregnant
- Women under 18 years of age or older than 70 years of age
- Women who are unable to provide consent for themselves, and for whom a parent, legal guardian, or legally authorized representative does not provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development
Bethesda, Maryland, 20892
About this study
Official title: PregSource: Crowdsourcing to Understand Pregnancy, Observations of Daily Living From Pregnant Women
PregSource uses a crowd-sourcing approach, asking pregnant women to enter information regularly and directly about their pregnancies throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants can track their data over time, print out reports to share with their healthcare team, and see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information about pregnancy management, issues, and complications.
More information is available at: https://pregsource.nih.gov
Read the detailed description
The objective of PregSource: Crowdsourcing to Understand Pregnancy (PregSource) is: to better understand the range of physical and emotional experiences and alterations in behavior that women have during pregnancy and after giving birth, the impact of these experiences on women's lives, and the perinatal challenges encountered by special sub-populations of women.
PregSource uses a longitudinal, crowd-sourcing, citizen science approach, asking pregnant women regularly and directly about their pregnancies. Participants enter information throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants will be able to track their pregnancy data over time, print out reports to share with their healthcare team, and view summaries of de-identified data to see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information from partner organizations about pregnancy management, issues, and complications.
Participants may also be a potential pool of recruits for clinical studies. Based on information they enter, eligible women who are interested in participating in clinical studies may be sent contact information about observational or interventional studies. Their contact information will not be shared directly with researchers.
After a critical mass of data is collected, de-identified data will be available to approved researchers for analysis.
If you are pregnant and interested in joining PregSource, please:
- Go to https://pregsource.nih.gov/.
- Select "Join" at the top of the page.
- Complete the questions on the Join page
- Complete the online consent form.
After that you will be asked some information for your account Profile, and you should start receiving/seeing questionnaires to complete on the My Dashboard page. You can also come in as often as you want/need to to complete PregSource's trackers to tell us about your mood, activity level, sleep, morning sickness, and weight gain. We also have a separate tracker for adding any medications, vitamins, and other supplements you may take during your pregnancy.
More information is available at: https://pregsource.nih.gov. If you have any additional questions, please let us know at pregsource@nih.gov.
- Conditions
- Pregnancy, Pregnancy Complications, Morning Sickness, Diabetes, Gestational, Placenta Diseases, Birth Weight
- Being tested
- No Interventions
- Keywords
- Pregnancy outcome, Neonatal outcome, Birth weight, Weight gain, Physical disability
- Medical subject headings
- Pregnancy Complications, Morning Sickness, Diabetes, Gestational, Placenta Diseases, Birth Weight, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No Interventions will be conducted under this study.
| Study group | Role | What they receive |
|---|---|---|
| 1 All Subjects | No interventions Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women delivering at each gestational week
Gestational age at pregnancy end date
Measured: Up to 44 weeks gestational age
Secondary outcomes (4)
Birthweight of baby
Birthweight of babies born >20 weeks gestational age
Measured: At delivery
Maternal weight gain in pregnancy by gestational age
Maternal weight gain in pregnancy by gestational age
Measured: Up to 44 weeks gestational age
Number of women without pregnancy complications
Pregnancy complications including: gestational diabetes, preeclampsia, placenta previa, etc.)
Measured: Up to 44 weeks gestational age
Number of live births
Number of infants born alive
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start25 Sep 2017
- Primary completion31 Oct 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 2,359 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Caroline C Signore, MD, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Melissa Parisi, MD PhD, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577536
- Sponsor's protocol ID
- PregSource
- Acronym
- PregSource
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2015
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be deposited into the NICHD data repository.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PregSource: Crowdsourcing to Understand Pregnancy, Observations of Daily Living From Pregnant Women
- ClinicalTrials.gov ID
- NCT02577536
- Acronym / sponsor ID
- PregSource / PregSource
- Conditions
- Pregnancy, Pregnancy Complications, Morning Sickness, Diabetes, Gestational, Placenta Diseases, Birth Weight
- Keywords
- Pregnancy outcome, Neonatal outcome, Birth weight, Weight gain, Physical disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,359 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 16 Oct 2015 (estimated)
- 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.
PregSource uses a crowd-sourcing approach, asking pregnant women to enter information regularly and directly about their pregnancies throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants can track their data over time, print out reports to share with their healthcare team, and see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information about pregnancy management, issues, and complications.
More information is available at: https://pregsource.nih.gov
Detailed description
The objective of PregSource: Crowdsourcing to Understand Pregnancy (PregSource) is: to better understand the range of physical and emotional experiences and alterations in behavior that women have during pregnancy and after giving birth, the impact of these experiences on women's lives, and the perinatal challenges encountered by special sub-populations of women.
PregSource uses a longitudinal, crowd-sourcing, citizen science approach, asking pregnant women regularly and directly about their pregnancies. Participants enter information throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants will be able to track their pregnancy data over time, print out reports to share with their healthcare team, and view summaries of de-identified data to see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information from partner organizations about pregnancy management, issues, and complications.
Participants may also be a potential pool of recruits for clinical studies. Based on information they enter, eligible women who are interested in participating in clinical studies may be sent contact information about observational or interventional studies. Their contact information will not be shared directly with researchers.
After a critical mass of data is collected, de-identified data will be available to approved researchers for analysis.
If you are pregnant and interested in joining PregSource, please:
- Go to https://pregsource.nih.gov/.
- Select "Join" at the top of the page.
- Complete the questions on the Join page
- Complete the online consent form.
After that you will be asked some information for your account Profile, and you should start receiving/seeing questionnaires to complete on the My Dashboard page. You can also come in as often as you want/need to to complete PregSource's trackers to tell us about your mood, activity level, sleep, morning sickness, and weight gain. We also have a separate tracker for adding any medications, vitamins, and other supplements you may take during your pregnancy.
More information is available at: https://pregsource.nih.gov. If you have any additional questions, please let us know at pregsource@nih.gov.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 All Subjects | – | Other: No InterventionsNo interventions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnancy women 18 years of age or older.
Key inclusion criteria (1 listed)
- Women who are pregnant
Key exclusion criteria (4 listed)
- Males
- Women who are not pregnant
- Women under 18 years of age or older than 70 years of age
- Women who are unable to provide consent for themselves, and for whom a parent, legal guardian, or legally authorized representative does not provide consent
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 |
|---|---|---|
| No InterventionsNo Interventions will be conducted under this study. | Other | 1 All Subjects |
Primary outcome
Number of women delivering at each gestational week
Time frame: Up to 44 weeks gestational age
Gestational age at pregnancy end date
4 secondary outcomes
Birthweight of baby
Time frame: At delivery
Maternal weight gain in pregnancy by gestational age
Time frame: Up to 44 weeks gestational age
Number of women without pregnancy complications
Time frame: Up to 44 weeks gestational age
Number of live births
Time frame: At birth
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 7 May 2024.
- PregSource home pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be deposited into the NICHD data repository.
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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.
Caroline C Signore, MD principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Melissa Parisi, MD PhD principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Pregnancy and Pregnancy Complications, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 1 inclusion and 4 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 7 May 2024. 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?
Number of women delivering at each gestational week (time frame: Up to 44 weeks gestational age). 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 7 May 2024.