138
Participants
Start Date
May 1, 2025
Primary Completion Date
September 1, 2027
Study Completion Date
May 1, 2028
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."
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"
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.
antibiotic prophylaxis
Antibiotics - Group B Streptococcus (GBS) prophylaxis + macrolides, always at admission.
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)."
NOT_YET_RECRUITING
University Hospital Brno, Brno
RECRUITING
General University Hospital in Prague, Prague
University Hospital Brno
UNKNOWN
General University Hospital, Prague
OTHER
The Central and Eastern European Gynecologic Oncology Group
OTHER