Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section. (SDvMD)
Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section in Mulago Hospital. A Randomized Clinical Trial.
調査の概要
詳細な説明
This is going to be an open label randomized controlled clinical trial that will involve 174 mothers delivered by elective cesarean section in Mulago National Referral hospital ward 5B antenatal and post natal wards.
Mulago hospital is at the apex of a 6 tier health system and is the largest public hospital with 31,400 deliveries annually 26.14% by cesarean section and of these 5.6% are elective cesarean sections.
Simple randomization was done where 174 cards were numbered 1-174 {(87 labelled Single Dose (SD) and 87 labelled Multiple Dose (MD)} inserted in an envelop shuffled and then the mother was allowed to pick a card randomly. This was done by the research assistant who reviewed the mother again in theater to ascertain if they still met the eligibility before the intervention was done.
Method This will be an open label single center superiority randomized clinical trial involving 174 eligible participants (87 in each arm) who will have delivered by elective cesarean section in Mulago hospital. They will be randomly allocated into two arms. One arm will receive single dose IV ceftriaxone 2g and metronidazole 500mg 30-60 minutes before the operation and the second arm will receive IV ceftraixone 1g with 500 mg of metronidazole during the operation and continue for 72 hours and discharged with oral antibiotics.
The mothers will be reviewed twice daily for evidence of infection. Their vitals (BP, Pulse, Temperature and respiratory rate), state of the wound and uterus, amount color and smell of the lochia during the first 2-3 post operative days. Both arms will have a 14 day follow up where they will come back for review on the 7th and 14th post operative day.
Objective:
The general objective is to compare the incidence of post operative infections among mothers that receive single dose pre operative Ceftriaxone and metronidazole compared to multiple doses at delivery by elective cesarean section in Mulago National Referral Hospital. at 14 day post operative.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Kampala、ウガンダ、00256
- Mulago National Refferal Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Antenatal mothers who have an indication for elective cesarean section in New Mulago hospital.
Exclusion Criteria:
- Mothers who have a history of allergy to any of the drugs in the study, Mother with visible infection at any site or elevated body temperature before going to theatre, Those with rapture of membranes, Mothers who went into labor, Mother who has had use of antibiotics in the last 7 days, WHO Clinical HIV stage III and IV and mothers who do not consent to the study.
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Single dose antibiotic
2g of intra venous Ceftriaxone and 500 mgs Intra venous metronidazole is administered to the mothers as a Single dose pre-operative30-60 minutes before surgery.
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Single dose arm receive 2g of IV Ceftriaxone and 500 mgs ofIntra venous Metronidazole given to the mothers 30-60 minutes pre operative.
他の名前：
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アクティブコンパレータ：multiple dose antibiotic.
Multiple doses of IV Ceftriaxone 1g and metronidazole 500mgs given to the mother during surgery there after Ceftriaxone 1g every day for 3 days and IV metronidazole 500 mgs every 8 hours for 3 days.
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Multiple dose arm receive 1 g of IV Cetriaxone plus 500 mgs during surgery and there after IV ceftriaxone once a day for 3 days and IV Metronidazole 500mgs during surgery and there after every 8 hours for 3 days.
他の名前：
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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 |
|---|---|---|
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Post operative wound infections
時間枠：14 days
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Compare for incidence of post operative wound infection among mothers that receive single dose versus multiple dose antibiotics
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14 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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clinical endometritis
時間枠：14 days
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Compare the incidence of clinical endometritis among mothers that receive single versus multiple dose antibiotics
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14 days
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febrile morbidity
時間枠：14 days
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compare the incidence of post operative febrile morbidity among mothers that receive single versus multiple doses
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14 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Mugisa Alex Gideon, MBChB.、Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology
- スタディディレクター：Paul Kiondo, MD, MMeD,PhD、Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology
- スタディディレクター：Imelda Namagembe, MD, MMeD, MPH、Mulago National Referral Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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