Phase
Condition
Influenza
Covid-19
Corona Virus
Treatment
Exposures
Clinical Study ID
Ages 18-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women aged 18 to 50 years registering for antenatal care (ANC) at Government Medical College Hospital (GMC) Nagpur, India
Estimated Gestational Age at registration <14 weeks based on ultrasound report atthe baseline study visit;
Intends to receive pregnancy, labor and delivery and neonatal care at GMC;
Plans to live within the city limits of Nagpur throughout their pregnancy and laborand delivery to facilitate access to GMC for evaluation of ILI and COVID-19symptoms;
Willing to be contacted two times per week by call or text for ILI/ COVID-19 symptomscreening and return to GMC for evaluation and an NP swab/evaluation if symptoms arereported;
Willing to take temperature with the provided digital thermometer, and maintain asymptom diary after training;
Willing to provide information on pregnancy and neonatal outcomes if care occursoutside GMC;
Willing to permit venous blood draws on at least 4 timepoints --1) Baseline studyvisit, 2)28-34 weeks, 3) 37 weeks - prior to delivery and 4) after delivery;
Willing to permit blood draws if hospitalized at GMC for COVID-19 infection;
Willing to consent to participate in the study
Exclusion
Exclusion Criteria:
Anyone who is deemed to have limited decision-making capacity as defined by BostonUniversity IRB i.e. Substantial impairment of cognitive functions (e.g. attention,comprehension, memory, and intellect), or conditions that might affect theircognitive functions.
Anyone who is deemed to have limited capacity to consent as defined by BostonUniversity Institutional Review Board (IRB) i.e. The ability to provide legallyeffective consent to enroll in a research study (AAHRPP definition).
Study Design
Study Description
Connect with a study center
Government. Medical College Hospital
Nagpur,
IndiaActive - Recruiting
Boston University School of Public Health, Global Health
Boston, Massachusetts 02118
United StatesActive - Recruiting
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