TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden
NCT ID: NCT07107477
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
138 participants
INTERVENTIONAL
2025-05-01
2028-05-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
ARM B: standard care
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weeks of pregnancy 22+03 - 33+64
* Singleton pregnancy
* Signed informed consent form (ICF)
* Completely uncomplicated pregnancy until the occurrence of pPROM
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital Brno
UNKNOWN
General University Hospital, Prague
OTHER
The Central and Eastern European Gynecologic Oncology Group
OTHER
Responsible Party
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David Cibula
Prof. Dr.
Locations
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University Hospital Brno
Brno, , Czechia
General University Hospital in Prague
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Nielsen VG, Andersen JB. [Acid secretion in patients with duodenal ulcer. Comparison of medical and surgical patients]. Ugeskr Laeger. 1970 Dec 3;132(49):2337-40. No abstract available. Danish.
Martins E Silva J. [Perspectives and clinical importance of hemorrheology--influence of erythrocyte deformability]. Acta Med Port. 1984 Apr-May;5(4-5):151-3. No abstract available. Portuguese.
Jen YM, Hendry JH. The distribution of colony-forming cells in the kidney. Cell Prolif. 1993 May;26(3):263-9. doi: 10.1111/j.1365-2184.1993.tb00024.x.
Jammet H, Dousset M. [Role of 2 international agencies (U.S.C.E.A.R. and I.C.R.P.) in radiologic protection]. Rev Epidemiol Sante Publique. 1982;30(2):265-73. No abstract available. French.
Hurme M. Both interleukin 1 and tumor necrosis factor enhance thymocyte proliferation. Eur J Immunol. 1988 Aug;18(8):1303-6. doi: 10.1002/eji.1830180824.
Goodrich JA, Sylvester R. Marketing EAPs: issues and prospects. J Ambul Care Mark. 1992;5(1):197-207. No abstract available.
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.
Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
Other Identifiers
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TAILORED-PROM 2024-520237-77-0
Identifier Type: -
Identifier Source: org_study_id
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