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Infection and Adverse Pregnancy Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673216
Recruitment Status : Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Preterm Birth Other: No intervention

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Study Type : Observational
Actual Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Infection and Adverse Pregnancy Outcome
Study Start Date : March 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Preterm birth <37 weeks of gestation [ Time Frame: 37 weeks of gestation ]

Biospecimen Retention:   Samples With DNA
Serum Vaginal Swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women attending for antenatal care or with spontaneous miscarriage
Criteria

Inclusion Criteria:

  • Pregnancy

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673216


Locations
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Denmark
Skejby University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
Statens Serum Institut
Aarhus University Hospital Skejby
Investigators
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Principal Investigator: Jorgen S Jensen, DMedSci, PhD Statens Serum Institut
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Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT02673216    
Other Study ID Numbers: 1-10-72-116-14
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications