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

2026년 4월 25일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

320

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 말레이시아
    • Sarawak
      • Kuching, Sarawak, 말레이시아, 93586
        • Sarawak General Hospital
        • 연락하다:
        • 연락하다:
          • Yan Hian Voon, Medical Degree
          • 전화번호: +6 0162317072
          • 이메일: vhaxyn@gmail.com
      • Miri, Sarawak, 말레이시아, 98000
        • Miri Hospital
        • 연락하다:
      • Sarikei, Sarawak, 말레이시아, 96100
        • Sarikei Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
의약품: 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.
실험적: 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
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical Chorioamnionitis
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Intrapartum Maternal Fever
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sarawak General Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 1월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2026년 4월 16일

QC 기준을 충족하는 최초 제출

2026년 4월 25일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 25일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PROMab-2026-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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