Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT01904669
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2013-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Study of Fertility and Early Pregnancy (PEEPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number enrolled', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Completeness of data collection', 'timeFrame': 'Following 9-21 months of data collection', 'description': 'Percentage of the study that the participant completed: baseline questionnaire (Y/N); daily trying to conceive journals (%); weekly pregnancy journals (%); and delivery information (%).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fertility', 'Infertility', 'Pregnancy', 'Conception', 'Behavioral', 'Lifestyle', 'Preconception Care', "Women's Health", 'Abortion, Spontaneous', 'Cohort Studies', 'Epidemiology', 'Internet'], 'conditions': ['Fertility', 'Infertility', 'Pregnancy', 'Abortion, Spontaneous']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://peeps.osumc.edu', 'label': 'PEEPS website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment with women completing daily journals for up to 12 months while trying to conceive and weekly through pregnancy if it occurs.', 'detailedDescription': 'There is a dearth of knowledge regarding the role that preconception health plays in fertility and early pregnancy loss. Classical methods of conducting prospective pregnancy studies with preconception enrollment to answer these questions are time-consuming in terms of recruitment efforts and expensive to carry out. The purpose of this project is to assess the feasibility of conducting an Internet-based prospective pregnancy study with preconception enrollment in the United States using the gold standard data collection approach of daily diaries during the trying to conceive period. We will accomplish this by enrolling 200 females of reproductive age who attempting to conceive and following them for up to 12 months and through pregnancy for those who become pregnant. Feasibility will be assessed by measuring: the number of women who screen eligible, the number of women who enroll, and compliance with journal use over time. We will also estimate the incidence of infertility, pregnancy and pregnancy loss as well as compare the demographics of women who enroll to the demographics of women who participate in community-based prospective pregnancy studies with preconception enrollment. The data from this project will be used to assess the feasibility of launching a larger prospective pregnancy study that is appropriately powered to examine the impact of preconceptional lifestyle factors on the incidence of infertility and early pregnancy loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We are looking for women ages 18-44 who are planning a pregnancy and have been trying to conceive for \\<3 months. Women must have reliable daily access to the Internet. The woman and her male partner may not have any known fertility problems.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Ages 18-44\n* In a stable relationship\n* Sexually active with a male partner\n* Reliable daily access to the Internet\n\nExclusion Criteria:\n\n* Woman or her partner has a known fertility problem\n* Trying to conceive for three or more months.'}, 'identificationModule': {'nctId': 'NCT01904669', 'acronym': 'PEEPS', 'briefTitle': 'Internet-based Study of Fertility and Early Pregnancy (PEEPS)', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Prospective Evaluation of the Elements of Pregnancy Study', 'orgStudyIdInfo': {'id': '2012H0128'}, 'secondaryIdInfos': [{'id': '1R03HD073504-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03HD073504-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women who are trying to conceive', 'description': 'Women ages 18-44 without a history of fertility problems who are in a stable relationship with a male partner who have regular access to the Internet and have been trying to conceive \\<3 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University College of Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Courtney D.Lynch, PhD MPH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Courtney D.Lynch, PhD MPH', 'investigatorAffiliation': 'Ohio State University'}}}}