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| Name | Class |
|---|---|
| Brno University Hospital | OTHER |
| General University Hospital, Prague | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A: TAilored management | Experimental | 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)
|
|
| ARM B: standard care | Active Comparator | Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the delivery (0-98 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to birth | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome in mother and newborn | Microbiome sequencing based on the bucal and rectal swabs. | Samples collected immediatelly after delivery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katerina Mackova, MD, PhD, PhD | Contact | +420733253563 | katerina.mackova@vfn.cz | |
| Martina Boricnova, PhD | Contact | +420736122654 | martina.borcinova@vfn.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno | Recruiting | Brno | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36098832 | Background | 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. | |
| 33128246 |
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Only IPD used in the results publication
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|
|
| Antenatal steroids administration | Drug |
|
|
| 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 |
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). |
|
| From the enrollment to the delivery (0-98 days). |
| Short-term adverse maternal outcomes | List of short-term adverse maternal outcomes:
| 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:
| From the birth to 6-months postpartum. |
| General University Hospital in Prague | Recruiting | Prague | 128 08 | Czechia |
|
| Institute for Mother and Child Care in Prague - Podolí | Recruiting | Prague | Czechia |
|
| 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. |
| 28257562 | Background | 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. |
| 33164775 | Background | 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. |
| 28544362 | Background | 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. |
| 28050900 | Background | 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. |
| 17205421 | Background | 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. |
| 18177778 | Background | 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. |
| 22000668 | Background | 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. |
| 37155446 | Background | 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. |
| 33121652 | Background | 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. |
| 32080050 | Background | Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700. |
| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
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| ID | Term |
|---|---|
| D000649 | Amniocentesis |
| D000066829 | Neuroprotection |
| D019072 | Antibiotic Prophylaxis |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D011296 | Prenatal Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |
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