A Phase 3 interventional study of Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes and Antenatal steroids administration in Preterm Premature Rupture of Membranes (PPROM), sponsored by The Central and Eastern European Gynecologic Oncology Group. Recruiting at 3 sites in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by The Central and Eastern European Gynecologic Oncology Group · Phase 3, Interventional, and Treatment
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:
Researchers will compare two groups:
Participants will:
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.
Exclusion Criteria:
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 · Drug: Antenatal steroids administration · Drug: Neuroprotection · Drug: antibiotic prophylaxis
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
Drug: Antenatal steroids administration · Drug: Neuroprotection · Drug: antibiotic prophylaxis · Drug: Antibiotics administration
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.
Also known as: amniocentesis
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
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.
Antibiotics - Group B Streptococcus (GBS) prophylaxis + macrolides, always at admission.
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).
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.
Time frame: From enrollment to the delivery (0-98 days).
Latency to birth
Time frame: Measured in days from pPROM to birth (0-98 days).
Incidence of chorioamnionitis and funisitis
Diagnosed during pregnancy based on clinical criteria or postpartum based on histological examination of placenta and umbilical cord.
Time frame: From the enrollment to the delivery (0-98 days).
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
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.
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
Time frame: From the birth to 6-months postpartum.
Microbiome in mother and newborn
Microbiome sequencing based on the bucal and rectal swabs.
Time frame: Samples collected immediatelly after delivery.
Plan to share: Undecided — Only IPD used in the results publication
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Preterm Premature Rupture of the Membranes
The Central and Eastern European Gynecologic Oncology Group