Infection and Adverse Pregnancy Outcome

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02673216

Enrollment

2200

Registered

2016-02-03

Start date

2015-09-30

Completion date

2023-12-31

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Brief 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.

Interventions

OTHERNo intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Pregnancy

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Preterm birth <37 weeks of gestation	37 weeks of gestation

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026