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NCT02673216 Clinical Trial

Infection and Adverse Pregnancy Outcome

Preterm Birth Clinical Trial

Official title:
Infection and Adverse Pregnancy Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02673216
Other study ID # 1-10-72-116-14
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2015
Est. completion date December 2023

Study information
Verified date May 2021
Source Statens Serum Institut
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2200
Est. completion date December 2023
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Pregnancy Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention

Locations
Country Name City State
Denmark Skejby University Hospital Aarhus

Sponsors (2)
Lead Sponsor Collaborator
Statens Serum Institut Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preterm birth <37 weeks of gestation 37 weeks of gestation
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