TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden (TAILORED-PROM)

June 16, 2026 updated by: David Cibula, The Central and Eastern European Gynecologic Oncology Group

Prospective Randomized Controlled Trial to Evaluate if Tailored Antibiotic and Steroid Therapy Based on the Interleukin-6 (IL-6) Value in Amniotic Fluid Obtained by Amniocentesis in Patients With Premature Rupture of Membranes is Associated With Pregnancy Prolongation Compared to Standard Management.

The goal of this clinical trial is to learn whether tailoring antibiotic and steroid treatment based on a lab result (interleukin-6, or IL-6) from amniotic fluid can help safely prolong pregnancy in people with preterm premature rupture of membranes (pPROM). This condition means the water breaks too early, before 37 weeks of pregnancy, which increases the risk of infection and early birth.

The main questions the study aims to answer are:

  1. Can using IL-6 levels to guide treatment help the pregnancy last more than 7 days after pPROM?
  2. Can this approach improve health outcomes for both the parent and the baby?

Researchers will compare two groups:

  1. A tailored treatment group, where IL-6 levels from amniotic fluid help decide when to give steroids and antibiotics.
  2. A standard care group, where everyone receives the same treatment right after diagnosis.

Participants will:

  • Be screened to confirm pPROM and eligibility.
  • Be randomly assigned to one of the two groups.
  • Receive regular check-ups and monitoring in the hospital until delivery.
  • In the tailored group, have weekly amniocentesis (a safe procedure to collect amniotic fluid) if needed.

The study includes follow-up for 6 months after birth to track both the baby's and parent's health.

This research may help doctors better time treatments, reduce unnecessary use of medications, and improve outcomes for families facing pPROM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia
        • Recruiting
        • University Hospital Brno
        • Contact:
      • Prague, Czechia, 128 08
        • Recruiting
        • General University Hospital in Prague
        • Contact:
      • Prague, Czechia
        • Recruiting
        • Institute for Mother and Child Care in Prague - Podolí
        • Contact:
          • Hynek Heřman, MD, Ph.D., LL.M., MHA
          • Phone Number: +420296511111
          • Email: info@upmd.eu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • pPPROM Confirmed by Amnisure test1 and/or clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic fluid during sterile speculum examination)
  • Weeks of pregnancy 22+03 - 33+64
  • Singleton pregnancy
  • Signed informed consent form (ICF)
  • Completely uncomplicated pregnancy until the occurrence of pPROM

Exclusion Criteria:

  • active labour (uterine activity leading to cervical dilatation greater than 4 cm)
  • Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress
  • Multiple pregnancy
  • Pregnancy with chromosomal or severe morphological abnormality
  • Signs of chorioamnionitis at the admission (clinical and/or laboratory)
  • Patients with severe immunological compromise (immunodeficient)
  • Patients with an oncological disease/immunosuppression
  • Patients with an active drug abuse
  • Non-compliant patients
  • Any contraindication according to the valid SmPC for the administered product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM A: TAilored management

No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital)

  • Based on the amniotic fluid IL-6 results:
  • IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids.
  • IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR
Procedure: Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes

In Arm A, Amniocentesis will be performed once a week until delivery, with a maximum of seven procedures per patient. If the pregnancy continues beyond this period, follow-up will proceed without further amniocentesis.

  • If IL-6 ≥ 2600:
  • steroids and initial broad spectrum ABX will be administered,
  • rotation of ABX according to cultures and PCR.
  • If steroids already administered, a second course can be administered prior to 34+0 if at least 7 days have passed after the previous course.
Other Names:
  • amniocentesis
Drug: Antenatal steroids administration
  1. Clinical and/or laboratory signs of chorioamnionitis will result in an intervention consisting of the course of antenatal steroids (if not already administered, or as a single course prior 34+0 if at least 7 days have passed after the previous course), initial broad spectrum antibiotics, or delivery, depending on the week of pregnancy and clinical status.
  2. Uterine activity with progression of vaginal finding will result in course of antenatal steroids (if not already administered, or as a single course prior 34+0 if at least 7 days have passed after the previous course) and tocolysis
Drug: Neuroprotection
In patients with imminent preterm birth prior 32+0 week of pregnancy, foetal neuroprotection will be administered consisting of MgSO4 in an intravenous loading dose of 4 g (administered slowly over 20-30 min), followed by a 1 g per hour maintenance dose. This regimen should continue until birth but should be stopped after 24 h if undelivered.
Drug: antibiotic prophylaxis
Antibiotics - Group B Streptococcus (GBS) prophylaxis + macrolides, always at admission.
Active Comparator: ARM B: standard care
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
Drug: Antenatal steroids administration
  1. Clinical and/or laboratory signs of chorioamnionitis will result in an intervention consisting of the course of antenatal steroids (if not already administered, or as a single course prior 34+0 if at least 7 days have passed after the previous course), initial broad spectrum antibiotics, or delivery, depending on the week of pregnancy and clinical status.
  2. Uterine activity with progression of vaginal finding will result in course of antenatal steroids (if not already administered, or as a single course prior 34+0 if at least 7 days have passed after the previous course) and tocolysis
Drug: Neuroprotection
In patients with imminent preterm birth prior 32+0 week of pregnancy, foetal neuroprotection will be administered consisting of MgSO4 in an intravenous loading dose of 4 g (administered slowly over 20-30 min), followed by a 1 g per hour maintenance dose. This regimen should continue until birth but should be stopped after 24 h if undelivered.
Drug: antibiotic prophylaxis
Antibiotics - Group B Streptococcus (GBS) prophylaxis + macrolides, always at admission.
Drug: Antibiotics administration
  1. GBS prophylaxis + macrolides: Penicillin G (benzylpenicillin) 5mil IU IV initially and then 2-3 IU (dose adjusted to body weight) IV every 4h twice, then every 6h + Clarithromycin 500mg po every 12h for 7-10 days or till delivery.
  2. Initial broad spectrum ABX: Ampicillin/sulbactam 3g IV every 6 hours + Gentamicin 5 mg/kg IV (<60 kg 240 mg, 61-80 kg 320 mg, >80 kg 400 mg) every 24h for 5-7 days according to the clinical state.

Comments:

Alternative ABX in patients with allergy to PCN/AMP: Vancomycin 1g IV every 12 h or Clindamycin 600-900g IV every 8h taking antibiotic sensitivity into account.

Before administering the third dose of gentamicin, its serum level should be determined (at a level >4 umol/l, the dose must be reduced).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The latency of pregnancy of more than 7 days from premature rupture of membranes to delivery
Time Frame: From enrollment to the delivery (0-98 days).
Latency ˃ 7d is an outcome traditionally used in trials studying pPROM and PTB.
From enrollment to the delivery (0-98 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latency to birth
Time Frame: Measured in days from pPROM to birth (0-98 days).
Measured in days from pPROM to birth (0-98 days).
Incidence of chorioamnionitis and funisitis
Time Frame: From the enrollment to the delivery (0-98 days).
Diagnosed during pregnancy based on clinical criteria or postpartum based on histological examination of placenta and umbilical cord.
From the enrollment to the delivery (0-98 days).
Short-term adverse maternal outcomes
Time Frame: From the enrollment to the 6 weeks postpartum. Time from enrollment to delivery is 0-14 weeks. Time frame ranges from 0-20 weeks.

List of short-term adverse maternal outcomes:

  1. mortality
  2. infection complication: sepsis, endometritis, wound infection, endometritis
  3. postpartum haemorrhage
  4. postpartum hysterectomy
  5. admission to the maternal intensive care unit
  6. unplanned operative procedure after delivery (dilation and curettage, laparoscopy, or laparotomy)
  7. injury requiring repair
  8. uterine rupture
  9. haemorrhage of >1000 mL
  10. transfusion
  11. acute renal insufficiency
  12. venous thromboembolism
  13. pulmonary embolism
  14. readmission to the hospital within 6 weeks
From the enrollment to the 6 weeks postpartum. Time from enrollment to delivery is 0-14 weeks. Time frame ranges from 0-20 weeks.
Short-term neonatal outcomes
Time Frame: From the birth to 6-months postpartum.

List of short-term neonatal outcomes:

  1. mortality
  2. gestational week at birth, birth weight and weight percentile
  3. status of antenatal steroids (expired/complete/incomplete)
  4. umbilical cord pH
  5. IL-6 from the umbilical cord
  6. Apgar score at 1 and 5 minutes
  7. need of intubation of the neonate after birth
  8. surfactant application
  9. days on ventilator
  10. the length of non-invasive respiratory support (postmenstrual week)
  11. the need for home oxygen therapy
  12. early pulmonary hypertension with iNO (Inhaled nitric oxide)
  13. patent ductus arteriosus (PDA) over 14 days over 1.5 mm/ ligation/ left ventricular outflow (LVO) over 450 ml/kg/min in 14 days)
  14. intraventricular haemorrhage (IVH) stage III-IV or periventricular leukomalacia (PVL) or other severe injury of brain visible on ultrasound
  15. bronchopulmonary dysplasia (BPD) stage II and III (Jensen)
  16. retinopathy of newborn (ROP) requiring invasive treatment
  17. necrotizing enterocolitis (NEC) with need of surgical so
From the birth to 6-months postpartum.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome in mother and newborn
Time Frame: Samples collected immediatelly after delivery.
Microbiome sequencing based on the bucal and rectal swabs.
Samples collected immediatelly after delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Central and Eastern European Gynecologic Oncology Group

Collaborators

Brno University Hospital
General University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

August 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAILORED-PROM 2024-520237-77-0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Only IPD used in the results publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Premature Rupture of Membranes (PPROM)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe