Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Conditions
Brief summary
In this study (study group) non-invasively measured fetal parameters in pregnant patients with preterm premature rupture of membranes (PPROM) or preterm parturation (cervical dilation before 37+0 weeks of gestation) will be examined for their association with short-term neonatal outcomes as well as with specific hematological and immunological parameters of the newborn. The control group includes pregnant women who are due to give birth around their due date (between 37+0 and 41+3 weeks of gestation, without premature rupture of membranes or preterm parturation).
Detailed description
The focus is on ultrasound assessments of the fetal thymus, spleen, and liver, as well as fetal echocardiography, as potential index parameters for predicting a clinical infection or fetal inflammatory response syndrome (FIRS) in the newborn.
Interventions
OTHERFetal ultrasound
Fetal ultrasound (spleen, liver, thymus, heart)
OTHERblood draw
maternal
OTHERvaginal swab
maternal
Sponsors
Medical University of Graz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Preterm rupture of membranes between 20+0 and 36+6 weeks of gestation * Expectant management with the goal of providing the highest level of neonatal care * Maternal age 18 years or older * Singleton pregnancy
Exclusion criteria
* Palliative care plan (neonatal "comfort care") * Maternal age under 18 * Multiple pregnancy * Significant fetal genetic abnormalities or malformations * Underlying maternal (auto)immune conditions * Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIRS | During the first week of life of the newborn | Interleukin-6 levels above 11 pg/ml and/or histological evidence of funisitis |
Countries
Austria
Outcome results
None listed