Term Prelabour Rupture of Membranes Antibiotic Prophylaxis (PROMab) Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Clinical Chorioamnionitis
研究概览
简要总结
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:
- undergo screening and eligibility assessment
- provide written informed consent before randomisation
- be randomly assigned to receive either intravenous ampicillin alone or intravenous ampicillin plus gentamicin
- start study antibiotics at 12 hours after membrane rupture and continue treatment until delivery
- 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
- optionally consent to placental tissue collection for microbiological culture at delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to treatment allocation. Treating clinicians and investigators will not be blinded because of weight-based gentamicin dosing, operational differences between antibiotic regimens, and the requirement for baseline renal function assessment prior to gentamicin administration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ampicillin (Drug)
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
干预措施: Ampicillin + gentamicin (Drug)
结局指标
主要结局
Clinical Chorioamnionitis
时间窗: 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.
次要结局
- Intrapartum Maternal Fever(From admission (diagnosis of PROM) until delivery (72 hours))
- Postpartum Fever During Index Admission(From admission (diagnosis of PROM) until delivery 7 days postpartum)
- Early Postpartum Endometritis During Index Admission(From admission (diagnosis of PROM) until delivery 7 days postpartum)
- Peripartum Infection During Index Admission(From admission (diagnosis of PROM) until delivery 7 days postpartum)
- Postpartum Antibiotic Treatment Exceeding 24 Hours(From admission (diagnosis of PROM) until delivery 7 days postpartum)
- Puerperal Endometritis After Discharge(From discharge until 42 days postpartum.)
- Wound Infection(From delivery until 42 days postpartum.)
- Infection-related Hospitalisation Longer Than 5 Days or Readmission for Infection(From delivery until 42 days postpartum.)
- Culture-proven Early-onset Neonatal Sepsis(Within the first 72 hours of life)
- Neonatal Sepsis Evaluation(From birth till 7 days of life)
- NICU Admission(From birth till 7 days of life)
- Composite Neonatal Adverse Outcome(From birth till 7 days of life)
- Presumed Early-onset Neonatal Sepsis(From birth till 7 days of life.)
- Infection-related Neonatal Hospitalisation Longer Than 5 Days or Readmission(From birth until 42 days of life.)
- Placental Chorioamniotic Tissue Culture(At delivery)
研究者
Jagdeesh Kaur
Obstetrics and Gynaecology Specialist, Maternal-Fetal Medicine Fellow
Sarawak General Hospital