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PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes (PROMab)

25. dubna 2026 aktualizováno: Jagdeesh Kaur, Sarawak General Hospital

Term Prelabour Rupture of Membranes Antibiotic Prophylaxis (PROMab) Trial

The goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged 18 years or older with singleton, cephalic, term pregnancies and confirmed prelabour rupture of membranes. The main questions it aims to answer are:

Does ampicillin plus gentamicin reduce the incidence of clinical chorioamnionitis compared with ampicillin alone? Does ampicillin plus gentamicin improve maternal infectious outcomes and neonatal infection-related outcomes compared with ampicillin alone?

Researchers will compare ampicillin alone with ampicillin plus gentamicin to see whether broader antibiotic coverage reduces maternal and neonatal infectious morbidity.

Participants will:

  1. undergo screening and eligibility assessment
  2. provide written informed consent before randomisation
  3. be randomly assigned to receive either intravenous ampicillin alone or intravenous ampicillin plus gentamicin
  4. start study antibiotics at 12 hours after membrane rupture and continue treatment until delivery
  5. undergo routine maternal and fetal monitoring during labour and delivery have maternal and neonatal outcomes assessed during hospital stay and up to 42 days postpartum, including telephone follow-up at Day 14 and Day 42
  6. optionally consent to placental tissue collection for microbiological culture at delivery

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

320

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Malajsie
    • Sarawak
      • Kuching, Sarawak, Malajsie, 93586
        • Sarawak General Hospital
        • Kontakt:
        • Kontakt:
          • Yan Hian Voon, Medical Degree
          • Telefonní číslo: +6 0162317072
          • E-mail: vhaxyn@gmail.com
      • Miri, Sarawak, Malajsie, 98000
        • Miri Hospital
        • Kontakt:
      • Sarikei, Sarawak, Malajsie, 96100
        • Sarikei Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 18 years or older
  • Singleton pregnancy
  • Cephalic (vertex) presentation
  • Term gestation of 37+0 weeks or more based on obstetric dating
  • Confirmed prelabour rupture of membranes
  • Duration of prelabour rupture of membranes 12 hours or less at the time of enrolment
  • Unknown or negative Group B Streptococcus status in the current pregnancy
  • Clear amniotic fluid at presentation
  • Afebrile with no clinical signs of intra-amniotic infection at admission
  • Able to provide written informed consent
  • Planned delivery at a participating study hospital

Exclusion Criteria:

  • Preterm prelabour rupture of membranes before 37+0 weeks
  • Fever of 38.0°C or higher, maternal tachycardia, uterine tenderness, purulent discharge, or other clinical suspicion of infection at admission
  • Antibiotics already initiated in the current episode of care for any reason
  • Receipt of systemic antibiotics in the past 7 days
  • Meconium-stained liquor at presentation
  • Contraindication to vaginal delivery, including malpresentation, major placenta praevia, maternal refusal of trial of labour after caesarean, or known absolute indication for elective lower segment caesarean section
  • Known Group B Streptococcus colonisation in the current pregnancy, including positive rectovaginal swab or bacteriuria
  • Abnormal cardiotocography on admission requiring expedited delivery
  • Allergy or contraindication to penicillin or aminoglycosides
  • Renal impairment defined as creatinine clearance less than 30 mL/min
  • Known renal disease
  • Known ototoxicity risk or vestibular/cochlear disorders
  • Unknown timing of prelabour rupture of membranes
  • Multiple gestation
  • Major fetal anomaly

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Ampicillin Alone
Participants randomized to this arm will receive intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. If clinical chorioamnionitis develops, study prophylaxis will be discontinued and therapeutic antibiotics will be started according to local hospital protocol.
Lék: Ampicillin
Intravenous ampicillin 2 g stat, followed by 1 g every 4 hours, initiated at 12 hours after prelabour rupture of membranes and continued until delivery.
Experimentální: Ampicillin Plus Gentamicin
Participants randomized to this arm will receive intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher. If clinical chorioamnionitis develops, study prophylaxis will be discontinued and therapeutic antibiotics will be started according to local hospital protocol
Lék: Ampicillin + gentamicin
Intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinical Chorioamnionitis
Časové okno: From admission (diagnosis of PROM) until delivery (72 hours)
Incidence of clinical chorioamnionitis, defined as maternal temperature ≥39.0°C once, or maternal temperature 38.0-38.9°C plus at least one of the following: leukocytosis >15,000/mm³, purulent cervical or vaginal discharge, fetal tachycardia (baseline fetal heart rate >160 bpm for ≥10 minutes), or malodorous liquor.
From admission (diagnosis of PROM) until delivery (72 hours)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Intrapartum Maternal Fever
Časové okno: From admission (diagnosis of PROM) until delivery (72 hours)
Incidence of intrapartum maternal fever, defined as axillary temperature ≥38.0°C on a single reading, or ≥37.5°C on two readings at least 1 hour apart during labour.
From admission (diagnosis of PROM) until delivery (72 hours)
Postpartum Fever During Index Admission
Časové okno: From admission (diagnosis of PROM) until delivery 7 days postpartum
Incidence of postpartum fever, defined as axillary temperature ≥38.0°C recorded at any time after delivery until discharge during the index hospital admission.
From admission (diagnosis of PROM) until delivery 7 days postpartum
Early Postpartum Endometritis During Index Admission
Časové okno: From admission (diagnosis of PROM) until delivery 7 days postpartum
Incidence of early postpartum endometritis diagnosed during the index hospital admission, defined as axillary temperature ≥38.0°C in the absence of an alternative identifiable cause and at least one associated clinical feature, including uterine tenderness, purulent or foul-smelling lochia, maternal tachycardia, or lower abdominal or uterine pain.
From admission (diagnosis of PROM) until delivery 7 days postpartum
Peripartum Infection During Index Admission
Časové okno: From admission (diagnosis of PROM) until delivery 7 days postpartum
Incidence of peripartum infection, defined as the occurrence of clinical chorioamnionitis and/or early postpartum endometritis during the same hospital admission.
From admission (diagnosis of PROM) until delivery 7 days postpartum
Postpartum Antibiotic Treatment Exceeding 24 Hours
Časové okno: From admission (diagnosis of PROM) until delivery 7 days postpartum
Incidence of systemic antibiotic therapy continued for more than 24 hours after delivery during the index hospital admission for suspected or confirmed infection, excluding routine single-dose perioperative prophylaxis for caesarean section.
From admission (diagnosis of PROM) until delivery 7 days postpartum
Puerperal Endometritis After Discharge
Časové okno: From discharge until 42 days postpartum.
Incidence of puerperal endometritis diagnosed after hospital discharge and up to 42 days postpartum, based on clinical documentation and/or requirement for antibiotic treatment for endometritis.
From discharge until 42 days postpartum.
Wound Infection
Časové okno: From delivery until 42 days postpartum.
Incidence of wound infection involving the caesarean section wound and/or perineal wound or episiotomy within 42 days postpartum, as evidenced by clinical diagnosis and/or treatment such as antibiotics, wound drainage, opening, or debridement.
From delivery until 42 days postpartum.
Infection-related Hospitalisation Longer Than 5 Days or Readmission for Infection
Časové okno: From delivery until 42 days postpartum.
Incidence of infection-related hospitalisation longer than 5 days during the index admission and/or hospital readmission within 42 days postpartum with a primary diagnosis of infection and/or requiring systemic antibiotic therapy
From delivery until 42 days postpartum.
Culture-proven Early-onset Neonatal Sepsis
Časové okno: Within the first 72 hours of life
Incidence of culture-proven early-onset neonatal sepsis, defined as isolation of a pathogenic organism from blood and/or cerebrospinal fluid culture, with clinical features consistent with infection.
Within the first 72 hours of life
Neonatal Sepsis Evaluation
Časové okno: From birth till 7 days of life
Incidence of neonatal sepsis evaluation, defined as performance of a neonatal septic work-up including one or more of the following: blood culture, full blood count, or other investigations performed as part of routine neonatal sepsis assessment.
From birth till 7 days of life
NICU Admission
Časové okno: From birth till 7 days of life
Incidence of admission to the neonatal intensive care unit at any time during the neonatal hospital stay, for any indication.
From birth till 7 days of life
Composite Neonatal Adverse Outcome
Časové okno: From birth till 7 days of life
Incidence of a composite neonatal adverse outcome defined as the occurrence of one or more of the following: requirement for ventilator support, tachypnoea with or without oxygen supplementation persisting beyond 6 hours of life, temperature instability requiring clinical intervention, or requirement for second-line antibiotics.
From birth till 7 days of life
Presumed Early-onset Neonatal Sepsis
Časové okno: From birth till 7 days of life.
Incidence of presumed early-onset neonatal sepsis, defined as culture-negative infants who receive at least 5 days of intravenous antibiotics based on clinical assessment, with or without supportive laboratory findings, as determined by the neonatal team.
From birth till 7 days of life.
Infection-related Neonatal Hospitalisation Longer Than 5 Days or Readmission
Časové okno: From birth until 42 days of life.
Incidence of neonatal hospitalisation longer than 5 days primarily attributed to suspected or confirmed infection and/or readmission within 42 days of life with a primary diagnosis of infection and/or requiring intravenous antibiotic therapy.
From birth until 42 days of life.
Placental Chorioamniotic Tissue Culture
Časové okno: At delivery
Placental chorioamniotic tissue culture results obtained at delivery and categorized into predefined microbiological groups, including Enterobacteriaceae, Group B Streptococcus, anaerobes, Enterococcus faecalis, and negative cultures.
At delivery

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sarawak General Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

31. ledna 2027

Dokončení studie (Odhadovaný)

31. března 2027

Termíny zápisu do studia

První předloženo

16. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PROMab-2026-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared because there is currently no formal data-sharing plan or repository arrangement for this investigator-initiated study.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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