NCT07869160

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Jan 2027

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

October 9, 2026

Status Verified

November 1, 2025

Enrollment Period

4.4 years

First QC Date

June 16, 2026

Last Update Submit

October 6, 2026

Conditions

Preterm ParturationPreterm Premature Rupture of Membranes (PPROM)

Outcome Measures

Primary Outcomes (1)

  • FIRS

    Interleukin-6 levels above 11 pg/ml and/or histological evidence of funisitis

    During the first week of life of the newborn

Other Outcomes (2)

  • Activation status of the neonatal immune system

    During the first week of life of the newborn

  • Activation of the maternal immune system

    From enrollment until birth

Study Arms (2)

Study group

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

Other: Fetal ultrasoundOther: blood drawOther: 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

Fetal ultrasoundOTHER

Fetal ultrasound (spleen, liver, thymus, heart)

Study group
blood drawOTHER

maternal

Control groupStudy group
vaginal swabOTHER

maternal

Study group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz Department of Obstetrics and Gynecology

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

October 9, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

October 9, 2026

Record last verified: 2025-11

Locations

AU(1)