Preterm ParturationPrePartNCT07869160
Preterm Parturation Study
An observational study of Preterm Parturation and Preterm Premature Rupture of Membranes (PPROM), run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
- What is being tested?
- Fetal ultrasound, blood draw and vaginal swab
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2027to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who have been admitted to the Clinical Department of Obstetrics at the Medical University of Graz for monitoring.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Graz Department of Obstetrics and Gynecology
Graz, Styria, 8010
Herbert Fluhr, +43 316 385 17069, herbert.fluhr@medunigraz.at
About this study
Official title: Preterm Parturation (PrePart) Studie
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.
- Being tested
- Fetal ultrasound, blood draw, vaginal swab
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal ultrasoundOther
Fetal ultrasound (spleen, liver, thymus, heart)
blood drawOther
maternal
blood drawOther
umbilical cord
vaginal swabOther
maternal
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with premature rupture of membranes/preterm parturation <37 weeks of gestation Receives: 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) Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIRS
Interleukin-6 levels above 11 pg/ml and/or histological evidence of funisitis
Measured: During the first week of life of the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm ParturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869160
- Sponsor's protocol ID
- 1420/2025
- Acronym
- PrePart
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Parturation (PrePart) Studie
- ClinicalTrials.gov ID
- NCT07869160
- Acronym / sponsor ID
- PrePart / 1420/2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Fetal ultrasound, Other: blood draw, Other: vaginal swabPatients with premature rupture of membranes/preterm parturation <37 weeks of gestation |
| Control group | – | Other: blood drawPatients with term parturation (37+0 to 41+3 weeks of pregnancy, without premature rupture of membranes/preterm parturation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who have been admitted to the Clinical Department of Obstetrics at the Medical University of Graz for monitoring.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Palliative care plan (neonatal "comfort care")
- Maternal age under 18
- Multiple pregnancy
- Significant fetal genetic abnormalities or malformations
- Underlying maternal (auto)immune conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal ultrasoundFetal ultrasound (spleen, liver, thymus, heart) | Other | Study group |
| blood drawmaternal | Other | Control group, Study group |
| blood drawumbilical cord | Other | Control group, Study group |
| vaginal swabmaternal | Other | Study group |
Primary outcome
FIRS
Time frame: During the first week of life of the newborn
Interleukin-6 levels above 11 pg/ml and/or histological evidence of funisitis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical University of Graz Department of Obstetrics and Gynecology
Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Parturation and Preterm Premature Rupture of Membranes (PPROM), run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIRS (time frame: During the first week of life of the newborn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.