Infection and Adverse Pregnancy Outcome

NCT ID: NCT02673216

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spontaneous abortion

Women attending for suspected spontaneous abortion

No intervention

Intervention Type OTHER

Normal pregnant women

Normal pregnant women attending for nuchal translucency scan

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnancy

Exclusion Criteria

* None
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital Skejby

OTHER

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorgen S Jensen, DMedSci, PhD

Role: PRINCIPAL_INVESTIGATOR

Statens Serum Institut

Locations

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Skejby University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-116-14

Identifier Type: -

Identifier Source: org_study_id

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