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NCT Number: NCT07107477

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

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.

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Key information

Conditions

Preterm Premature Rupture of Membranes (PPROM) Preterm Premature Rupture of the Membranes

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Brno, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Antenatal steroids administration

Drug
  • 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.
  • 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

Neuroprotection

Drug

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 Prophylaxis

Drug

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

Antibiotics administration

Drug
  • 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.
  • 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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Latency to birth

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

  2. 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.

  3. 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:

    • mortality
    • infection complication: sepsis, endometritis, wound infection, endometritis
    • postpartum haemorrhage
    • postpartum hysterectomy
    • admission to the maternal intensive care unit
    • unplanned operative procedure after delivery (dilation and curettage, laparoscopy, or laparotomy)
    • injury requiring repair
    • uterine rupture
    • haemorrhage of >1000 mL
    • transfusion
    • acute renal insufficiency
    • venous thromboembolism
    • pulmonary embolism
    • readmission to the hospital within 6 weeks

  4. Short-term neonatal outcomes

    Time frame: From the birth to 6-months postpartum.

    List of short-term neonatal outcomes:

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

Other outcomes

  1. Microbiome in mother and newborn

    Time frame: Samples collected immediatelly after delivery.

    Microbiome sequencing based on the bucal and rectal swabs.

Study contacts

Contact information is provided by the study sponsor or research team.

Katerina Mackova, MD, PhD, PhD

CONTACT

[email protected]

+420733253563

Martina Boricnova, PhD

CONTACT

[email protected]

+420736122654

Sponsors and collaborators

Lead sponsor

The Central and Eastern European Gynecologic Oncology Group

Other

Collaborators

  • Brno University Hospital
  • General University Hospital, Prague

Registry information

Official study 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.

Acronym: TAILORED-PROM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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