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

25. April 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

320

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Arzneimittel: 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.
Experimental: 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
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical Chorioamnionitis
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intrapartum Maternal Fever
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sarawak General Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Januar 2027

Studienabschluss (Geschätzt)

31. März 2027

Studienanmeldedaten

Zuerst eingereicht

16. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PROMab-2026-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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