NCT02673216

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

5.3 years

First QC Date

January 27, 2016

Last Update Submit

May 6, 2021

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Preterm birth <37 weeks of gestation

    37 weeks of gestation

Study Arms (2)

Spontaneous abortion

Women attending for suspected spontaneous abortion

Other: No intervention

Normal pregnant women

Normal pregnant women attending for nuchal translucency scan

Other: No intervention

Interventions

No interventionOTHER
Normal pregnant womenSpontaneous abortion

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women attending for antenatal care or with spontaneous miscarriage

You may qualify if:

  • Pregnancy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skejby University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Vaginal Swabs

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jorgen S Jensen, DMedSci, PhD

    Statens Serum Institut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 3, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2023

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)