Infection and Adverse Pregnancy Outcome

• Conditions: Preterm Birth
• Interventions: Other: No intervention

• Registration Number: NCT02673216
• Lead Sponsor: Statens Serum Institut

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Primary Completion: 2020-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2200

Inclusion Criteria

• Pregnancy

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal pregnant women	No intervention	Normal pregnant women attending for nuchal translucency scan
Spontaneous abortion	No intervention	Women attending for suspected spontaneous abortion

Primary Outcome Measures

Name	Time	Method
Preterm birth <37 weeks of gestation	37 weeks of gestation

Trial Locations

Locations (1)

Skejby University Hospital; 🇩🇰 Aarhus, Denmark