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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

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

320

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • マレーシア
    • Sarawak
      • Kuching、Sarawak、マレーシア、93586
        • Sarawak General Hospital
        • コンタクト：
        • コンタクト：
          • Yan Hian Voon, Medical Degree
          • 電話番号：+6 0162317072
          • メール：vhaxyn@gmail.com
      • Miri、Sarawak、マレーシア、98000
        • Miri Hospital
        • コンタクト：
      • Sarikei、Sarawak、マレーシア、96100
        • Sarikei Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
薬：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.
実験的：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
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Clinical Chorioamnionitis
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Intrapartum Maternal Fever
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sarawak General Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年1月31日

研究の完了 (推定)

2027年3月31日

試験登録日

最初に提出

2026年4月16日

QC基準を満たした最初の提出物

2026年4月25日

最初の投稿 (実際)

2026年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月4日

QC基準を満たした最後の更新が送信されました

2026年4月25日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PROMab-2026-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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