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Not yet recruitingNCT07869160PrePartUpdated Oct 9, 2026

Preterm Parturation Study

An observational study in Preterm Parturation and Preterm Premature Rupture of Membranes (PPROM), sponsored by Medical University of Graz. Not yet recruiting at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Medical University of Graz · Observational

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
Female
01

Study 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).

Read the 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.

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Conditions studied

  • Preterm Parturation
  • Preterm Premature Rupture of Membranes (PPROM)
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In context

Lead sponsor

Medical University of Graz is the lead sponsor of 470 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women who have been admitted to the Clinical Department of Obstetrics at the Medical University of Graz for monitoring.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    Patients with premature rupture of membranes/preterm parturation \<37 weeks of gestation

    Other: Fetal ultrasound · Other: blood draw · Other: vaginal swab

  • Control group

    Patients with term parturation (37+0 to 41+3 weeks of pregnancy, without premature rupture of membranes/preterm parturation)

    Other: blood draw

Interventions

  • OtherFetal ultrasound

    Fetal ultrasound (spleen, liver, thymus, heart)

  • Otherblood draw

    maternal

  • Otherblood draw

    umbilical cord

  • Othervaginal swab

    maternal

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What researchers measure

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 newborn

Other 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 newborn

  2. Activation of the maternal immune system

    * Ratio of pro- versus antiinflammatory leukocytes * Ratio of pro- versus antiinflammatory cytokines

    Time frame: From enrollment until birth

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Study locations

1 site
  • Medical University of Graz Department of Obstetrics and Gynecology
    Graz, Styria 8010, Austria
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07869160
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jun 2031 (estimated)
Completion
Jun 2031 (estimated)
Last update
Oct 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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