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

2026年4月25日 更新者：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

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

320

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 马来西亚
    • Sarawak
      • Kuching、Sarawak、马来西亚、93586
        • Sarawak General Hospital
        • 接触：
        • 接触：
          • Yan Hian Voon, Medical Degree
          • 电话号码：+6 0162317072
          • 邮箱：vhaxyn@gmail.com
      • Miri、Sarawak、马来西亚、98000
      • Sarikei、Sarawak、马来西亚、96100
        • Sarikei Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
药品：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.
实验性的：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
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Clinical Chorioamnionitis
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Intrapartum Maternal Fever
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sarawak General Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年4月25日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月25日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PROMab-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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