Preterm Parturation Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical University of Graz
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Palliative care plan (neonatal "comfort care")
Maternal age under 18
Multiple pregnancy
Significant fetal genetic abnormalities or malformations
Trial population
Pregnant women who have been admitted to the Clinical Department of Obstetrics at the Medical University of Graz for monitoring.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fetal ultrasound
Other interventionFetal ultrasound (spleen, liver, thymus, heart)
blood draw
Other interventionmaternal
blood draw
Other interventionumbilical cord
vaginal swab
Other interventionmaternal
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Study group3 interventions
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
FIRS
Interleukin-6 levels above 11 pg/ml and/or histological evidence of funisitis
Time frame
During the first week of life of the newbornOther outcomes
1
Activation status of the neonatal immune system
* Ratio of pro- versus antiinflammatory leukocytes * Ratio of pro- versus antiinflammatory cytokines
Time frame
During the first week of life of the newborn2
Activation of the maternal immune system
* Ratio of pro- versus antiinflammatory leukocytes * Ratio of pro- versus antiinflammatory cytokines
Time frame
From enrollment until birthSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: