Tranexamic Acid Versus Misoprostol to Reduce Blood Loss During and After Cesarean Section
Comparison of the Effect of Tranexamic Acid Versus Misoprostol on Blood Loss During and After Cesarean Section
Brief Summary
The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment.
The main questions the study aims to answer are:
- Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section?
- Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol?
Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians.
Participants will:
i. Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery.
ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery.
iii. Have blood loss measured during the operation and for 2 hours after surgery.
iv. Have the duration of the operation recorded as part of the study.
The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.
調査の概要
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
-
-
Punjab Province
-
Multan、Punjab Province、パキスタン、60000
- Medicare Hospital (Pvt) Limited
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 37 to 42 weeks of gestation
- Planned cesarean section
Exclusion Criteria:
- Women with pre-eclampsia
- Chronic hypertension
- Multiple pregnancies
- Preterm or postdate pregnancy
- Previous cesarean section
- Gestational diabetes
- Fetal macrosomia
- History of bleeding / clotting disorder
- On anti-coagulation heparin / warfarin therapy
- Non-reassuring cardiotocograph or poor progress of labor
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：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 |
|---|---|
|
実験的：Intravenous Tranexamic Acid
Participants will receive intravenous tranexamic acid
|
1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section
|
|
アクティブコンパレータ：Rectal Misoprostol
Participants will receive rectal Misoprostol
|
1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section
|
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 |
|---|---|---|
|
Reduction in Hemoglobin
時間枠：Baseline at enrollment and postoperative within 2 hours
|
Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).
|
Baseline at enrollment and postoperative within 2 hours
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Blood Loss
時間枠：From the start of cesarean section to postoperatively until two hours
|
Total blood loss will be measured as the sum of blood collected in the suction container during surgery and blood absorbed by pre-weighed surgical gauze and sanitary pads (1 g = 1 mL) from the start of surgery until 2 hours after cesarean section.
|
From the start of cesarean section to postoperatively until two hours
|
協力者と研究者
捜査官
- スタディチェア：Shahid I Rao, FCPS、Medicare Hospital (Pvt) Limited
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
その他の研究ID番号
- U1111-1343-7865
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?
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
米国FDA規制機器製品の研究
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。