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Infection and Adverse Pregnancy Outcome

NCT02673216 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2021-05-10

No results posted yet for this study

Summary

Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. The investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV) subclasses, to vaginal fluid inflammation markers, and to the presence of novel Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.

Conditions

Interventions

OTHER

No intervention

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    collaborator OTHER

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Jorgen S Jensen, DMedSci, PhD · Statens Serum Institut

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02673216 on ClinicalTrials.gov