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Trial record 9 of 13 for:    infant health | Recruiting, Not yet recruiting, Available Studies | nichd [Lead] | NIH

PregSource: Crowdsourcing to Understand Pregnancy (PregSource)

This study is not yet open for participant recruitment.
Verified August 2017 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02577536
First Posted: October 16, 2015
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
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.

Condition Intervention
Pregnancy Pregnancy Complications Morning Sickness Diabetes, Gestational Placenta Diseases Birth Weight Other: No Interventions

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PregSource: Crowdsourcing to Understand Pregnancy, Observations of Daily Living From Pregnant Women

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Number of women delivering at each gestational week [ Time Frame: Up to 44 weeks gestational age ]
    Gestational age at pregnancy end date


Secondary Outcome Measures:
  • Birthweight of baby [ Time Frame: At delivery ]
    Birthweight of babies born >20 weeks gestational age

  • Maternal weight gain in pregnancy by gestational age [ Time Frame: Up to 44 weeks gestational age ]
    Maternal weight gain in pregnancy by gestational age

  • Number of women without pregnancy complications [ Time Frame: Up to 44 weeks gestational age ]
    Pregnancy complications including: gestational diabetes, preeclampsia, placenta previa, etc.)

  • Number of live births [ Time Frame: At birth ]
    Number of infants born alive


Estimated Enrollment: 100000
Anticipated Study Start Date: September 15, 2017
Estimated Study Completion Date: September 15, 2021
Estimated Primary Completion Date: September 15, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 All Subjects
No interventions
Other: No Interventions
No Interventions will be conducted under this study.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All pregnancy women 18 years of age or older.
Criteria

Inclusion Criteria:

  • Women who are pregnant

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577536


Contacts
Contact: Stephanie Wilson Archer, MA 301-496-0430 PregSource@nih.gov
Contact: Sujata Bardhan, PhD (301) 496-1383 sujata.bardhan@nih.gov

Locations
United States, Maryland
National Institute of Child Health and Human Development Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: Caroline C Signore, MD    301-496-5577    signorec@mail.nih.gov   
Contact: Stephanie Wilson Archer, MA    301-496-0430    archerst@mail.nih.gov   
Sub-Investigator: Sujata Bardhan, PhD         
Sub-Investigator: Lisa Kaeser, JD         
Sub-Investigator: Melissa Parisi, MD PhD         
Sub-Investigator: Debbie Jae, MS         
Sub-Investigator: Vanessa Rangel Miller, MS CGC MBA         
Sub-Investigator: Jud Rhode         
Sub-Investigator: Albert Carrasco         
Sub-Investigator: Scott Clarke         
Sub-Investigator: Jan Laibe         
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Caroline C Signore, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Melissa Parisi, MD PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT02577536     History of Changes
Obsolete Identifiers: NCT02659969
Other Study ID Numbers: PregSource
First Submitted: October 5, 2015
First Posted: October 16, 2015
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be deposited into the NICHD data repository.

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Pregnancy outcome
Neonatal outcome
Birth weight
Weight gain
Physical disability

Additional relevant MeSH terms:
Birth Weight
Pregnancy Complications
Diabetes, Gestational
Morning Sickness
Placenta Diseases
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vomiting
Signs and Symptoms, Digestive