APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorShanghai General Hospital, China

About this trial

Adverse pregnancy outcomes (APOs) are a collection of conditions that have short-term and long-term effects of complications related to pregnancy and childbirth on pregnant women and their fetuses, including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, large for gestational age, among others. Nearly 30% of all women experience an adverse pregnancy outcome during their reproductive years. Although, respiratory viral infections with epidemic and pandemic potential pose an omnipresent threat to public health, research focusing specifically on the maternal-infant population remains relatively scarce.

Studies conducted in USA found that among pregnant women infected with influenza, the proportion of those with gestational hypertension or diabetes was higher than in pregnant women without influenza infection (13.9% vs. 11.1%).

Research on the impact of respiratory viral infections on perinatal outcomes in China is limited, and we aim to establish of a large-scale, retroprospective maternal-child cohorts. This cohort study will systematically collect longitudinal data (e.g., detailed clinical history, timing of infection/vaccination, complication of pregnancy, and APOs) to assess the risk of respiratory viral infections to APOs, as well as facilitate multidisciplinary research.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female;

Age 20 to 45 years old;

Physician-diagnosed acute respiratory viral infection occurring within 6 months before pregnancy and/or at <24 weeks of gestation.

Disqualifiers

Pregestational T1D or T2D;

Long-term use of immunosuppressants or glucocorticoids;

Diseases that severely affect immune or metabolic function (e.g., HIV, SLE, rheumatoid arthritis);

Severe mental illness or cognitive impairment;

Trial population

Women who are planning to conceive or pregnant women.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,440 Participants
are grouped into 2 trial groups
Group A: Respiratory viral infections cohort
Group B: Control cohort

Trial outcomes

Primary outcomes

1

incidence of gestational diabetes mallitus

incidence of gestational diabetes mallitus according to International Association of Diabetes and Pregnancy Study Groups consensus if any one of the plasma glucose values is met or exceeded during a 75g oral glucose tolerance test (OGTT) at 20 to 28 gestational weeks.

Time frame
28 weeks of gestation

Secondary outcomes

1

incidence of preterm birth

incidence of any births that occur before 37 completed weeks of gestation

Time frame
37 gestational weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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