Infection and Adverse Pregnancy Outcome

Statens Serum Institut

Status: Unknown

Conditions: Preterm Birth

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02673216

1-10-72-116-14

Details and patient eligibility

About

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.

Enrollment: 2,200 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnancy

Exclusion criteria

• None

Trial design

2,200 participants in 2 patient groups

Spontaneous abortion

Description:

Women attending for suspected spontaneous abortion

Treatment:

Other: No intervention

Normal pregnant women

Description:

Normal pregnant women attending for nuchal translucency scan

Treatment:

Other: No intervention