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Preterm Premature Rupture of Membranes (PPROM)Phase 3TAILORED-PROMNCT07107477

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

A Phase 3 study testing Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes, Antenatal steroids administration and Neuroprotection in people with Preterm Premature Rupture of Membranes (PPROM), run by The Central and Eastern European Gynecologic Oncology Group at 3 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes, Antenatal steroids administration and Neuroprotection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
3 sitesCzechia
Study dates
1 May 2025to 1 May 2028
Phase
Phase 3
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

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Katerina Mackova, MD, PhD, PhD contact

+420733253563

katerina.mackova@vfn.cz

Martina Boricnova, PhD contact

+420736122654

martina.borcinova@vfn.cz

Czechia3 sites, 3 recruiting

  • University Hospital Brno

    Brno

    Lukas Hruban, Ass. Prof., +420532233961, Hruban.Lukas@fnbrno.cz

    Recruiting

  • General University Hospital in Prague

    Prague, 128 08

    Martina Borčinová, 736122654, martina.borcinova@vfn.cz

    Recruiting

  • Institute for Mother and Child Care in Prague - Podolí

    Prague

    Hynek Heřman, MD, Ph.D., LL.M., MHA, +420296511111, info@upmd.eu

    Recruiting

Other trials in Czechia

About this study

Official title: 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:

Read more
  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.

Being tested
Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes, Antenatal steroids administration, Neuroprotection, antibiotic prophylaxis, Antibiotics administration
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.

  • Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranesProcedure or surgery

    Also called amniocentesis

    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.

  • Antenatal steroids administrationDrug

    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

  • NeuroprotectionDrug

    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.

  • antibiotic prophylaxisDrug

    Antibiotics - Group B Streptococcus (GBS) prophylaxis + macrolides, always at admission.

  • Antibiotics administrationDrug

    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).

Study groups in NCT07107477
Study groupRoleWhat they receive
ARM A: TAilored managementExperimentalNo 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
Receives: 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; Drug: Antenatal steroids administration; Drug: Neuroprotection; Drug: antibiotic prophylaxis
ARM B: standard careActive comparatorAntenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
Receives: Drug: Antenatal steroids administration; Drug: Neuroprotection; Drug: antibiotic prophylaxis; Drug: Antibiotics administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The latency of pregnancy of more than 7 days from premature rupture of membranes to delivery

    Latency ˃ 7d is an outcome traditionally used in trials studying pPROM and PTB.

    Measured: From enrollment to the delivery (0-98 days).

Secondary outcomes (4)

  1. Latency to birth

    Measured: Measured in days from pPROM to birth (0-98 days).

  2. Incidence of chorioamnionitis and funisitis

    Diagnosed during pregnancy based on clinical criteria or postpartum based on histological examination of placenta and umbilical cord.

    Measured: From the enrollment to the delivery (0-98 days).

  3. Short-term adverse maternal outcomes

    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

    Measured: From the enrollment to the 6 weeks postpartum. Time from enrollment to delivery is 0-14 weeks. Time frame ranges from 0-20 weeks.

  4. Short-term neonatal outcomes

    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

    Measured: From the birth to 6-months postpartum.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start1 May 2025
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07107477
Sponsor's protocol ID
TAILORED-PROM 2024-520237-77-0
Acronym
TAILORED-PROM
Status last verified
Jun 2026
First submitted
22 Jul 2025
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Only IPD used in the results publication

Publications

  • Brun R, Girsberger J, Rothenbuhler M, Argyle C, Hutmacher J, Haslinger C, Leeners B. Wearable sensors for prediction of intraamniotic infection in women with preterm premature rupture of membranes: a prospective proof of principle study. Arch Gynecol Obstet. 2023 Nov;308(5):1447-1456. doi: 10.1007/s00404-022-06753-4. Epub 2022 Sep 13.

    PubMed 36098832

  • Visser GHA, Thommesen T, Di Renzo GC, Nassar AH, Spitalnik SL; FIGO Committee for Safe Motherhood, Newborn Health. FIGO/ICM guidelines for preventing Rhesus disease: A call to action. Int J Gynaecol Obstet. 2021 Feb;152(2):144-147. doi: 10.1002/ijgo.13459. Epub 2021 Jan 9.

    PubMed 33128246

  • Bond DM, Middleton P, Levett KM, van der Ham DP, Crowther CA, Buchanan SL, Morris J. Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome. Cochrane Database Syst Rev. 2017 Mar 3;3(3):CD004735. doi: 10.1002/14651858.CD004735.pub4.

    PubMed 28257562

  • Jung E, Romero R, Yeo L, Diaz-Primera R, Marin-Concha J, Para R, Lopez AM, Pacora P, Gomez-Lopez N, Yoon BH, Kim CJ, Berry SM, Hsu CD. The fetal inflammatory response syndrome: the origins of a concept, pathophysiology, diagnosis, and obstetrical implications. Semin Fetal Neonatal Med. 2020 Aug;25(4):101146. doi: 10.1016/j.siny.2020.101146. Epub 2020 Oct 23.

    PubMed 33164775

  • Romero R, Chaemsaithong P, Chaiyasit N, Docheva N, Dong Z, Kim CJ, Kim YM, Kim JS, Qureshi F, Jacques SM, Yoon BH, Chaiworapongsa T, Yeo L, Hassan SS, Erez O, Korzeniewski SJ. CXCL10 and IL-6: Markers of two different forms of intra-amniotic inflammation in preterm labor. Am J Reprod Immunol. 2017 Jul;78(1):e12685. doi: 10.1111/aji.12685. Epub 2017 May 19.

    PubMed 28544362

  • Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.

    PubMed 28050900

  • Romero R, Espinoza J, Goncalves LF, Kusanovic JP, Friel L, Hassan S. The role of inflammation and infection in preterm birth. Semin Reprod Med. 2007 Jan;25(1):21-39. doi: 10.1055/s-2006-956773.

    PubMed 17205421

  • Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.

    PubMed 18177778

  • Mercer BM, Crouse DT, Goldenberg RL, Miodovnik M, Mapp DC, Meis PJ, Dombrowski MP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The antibiotic treatment of PPROM study: systemic maternal and fetal markers and perinatal outcomes. Am J Obstet Gynecol. 2012 Feb;206(2):145.e1-9. doi: 10.1016/j.ajog.2011.08.028. Epub 2011 Sep 8.

    PubMed 22000668

  • Garg A, Jaiswal A. Evaluation and Management of Premature Rupture of Membranes: A Review Article. Cureus. 2023 Mar 24;15(3):e36615. doi: 10.7759/cureus.36615. eCollection 2023 Mar.

    PubMed 37155446

  • Boettcher LB, Clark EAS. Neonatal and Childhood Outcomes Following Preterm Premature Rupture of Membranes. Obstet Gynecol Clin North Am. 2020 Dec;47(4):671-680. doi: 10.1016/j.ogc.2020.09.001. Epub 2020 Oct 7.

    PubMed 33121652

  • Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

    PubMed 32080050

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes, Antenatal steroids administration and Neuroprotection in people with Preterm Premature Rupture of Membranes (PPROM), run by The Central and Eastern European Gynecologic Oncology Group at 3 sites in Czechia.

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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Katerina Mackova, MD, PhD, PhD (+420733253563, katerina.mackova@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07107477, which also lists 12 linked publications.

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 18 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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