Trials / Unknown
UnknownNCT02673216
Infection and Adverse Pregnancy Outcome
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,200 (actual)
- Sponsor
- Statens Serum Institut · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2020-12-01
- Completion
- 2023-12-01
- First posted
- 2016-02-03
- Last updated
- 2021-05-10
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02673216. Inclusion in this directory is not an endorsement.