Randomization of Oxytocin, Oxytocin+Intrauterine Misoprostol and Carbetocin During C-section
Randomized Controlled Comparison of Blood Loss in Patients Who Received Oxytocin Infusion, Oxytocin Infusion, and Intrauterine Misoprostol and Carbetocin During Cesarean Delivery
調査の概要
詳細な説明
Our prospective, randomized controlled study was conducted at the Department of Obstetrics and Gynecology of Bezmialem University Hospital between July and November 2021. The study protocol was approved by the Ethical Committee of the Medical Faculty of Bezmialem University. Written informed consent was obtained from all patients. We included a total of 156 women between 18 and 40 years of age who underwent a primary cesarean section or old 1 cesarean section under spinal anesthesia at term single pregnancy with an American Society of Anesthesiology physical status of I or II. This trial was designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
The patients included in this study were randomly divided into three groups by random allocation using a computer-generated random number. Group I: Oxytocin(Synpitan forte®; Deva Pharma, Istanbul, Turkey) (n = 52 )( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord). Group II: (n =52) oxytocin plus intrauterine misoprostol (Synpitan forte®; Deva Pharma, Istanbul, Turkey) (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III: (n =52) 100-mg carbetocin (Synpitan forte®; Deva Pharma, Istanbul, Turkey) was intravenously administered immediately after birth of the baby. All surgeries were performed by the same team of two surgeons.. The collected data were age, prepregnancy body mass index (BMI), gravida, parity, indication of cesarean section, gestational age at birth, Apgar scores at 1 and 5 min, birth weight, neonatal intensive care unit (NICU) admission, the preoperative hemoglobin and hematocrit concentrations, the change in the hemoglobin and hematocrit concentrations (difference between preoperative and postoperative levels), operating time, intraoperative blood loss.
In this study, the investigators aimed to compare the efficacy of oxytocin, misoprostol and carbetocin in preventing uterine blood loss during cesarean section.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Istanbul、七面鳥
- Bezmialem Vakif University
-
-
Istanbulk
-
Istanbul、Istanbulk、七面鳥
- Bezmialem Vakif University
-
-
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:
- Single pregnancy greater than 37 weeks
- Pregnant women between the ages of 18-40 Volunteer
Exclusion Criteria:
- Clinical diagnosis of Gestational diabetes
- Clinical diagnosis of Gestational hypertension
- Clinical diagnosis of preeclampsia
- Clinical diagnosis of Placenta previa,
- Clinical diagnosis of abruptio placenta
- Conditions that cause excessive distention of the uterus (multiple pregnancies, severe polyhydramnios, fetal macrosomia, large fibroids displacing the cavity) Thrombophilia disorders, anticoagulation therapy History of major abdominal surgery
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:カルベトシン
出産直後にカルベトシン100mgを静脈内投与
|
Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord).
Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity.
Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
他の名前:
|
|
実験的:オキシトシングループ
20 IU を 500 mL の通常の 0.9 % 塩化ナトリウム溶液に溶解し、毎時 125 mL の速度で注入するオキシトシン注入は、臍帯をクランプした直後に投与されました。
|
Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord).
Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity.
Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
他の名前:
|
|
実験的:Oxytocin+Intrauterine Misoprostol
The oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity
|
Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord).
Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity.
Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
他の名前:
|
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 |
|---|---|---|
|
Hemogram status
時間枠:Postoperative 8th hour
|
Postoperative hemogram status
|
Postoperative 8th hour
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Transfusion
時間枠:Postoperative 24th hour
|
Number of patients needing Blood Transfusion
|
Postoperative 24th hour
|
協力者と研究者
捜査官
- スタディチェア:Gurkan Kıran, MD、Bezmialem Vakif University
出版物と役立つリンク
一般刊行物
- Ibrahim ZM, Sayed Ahmed WA, Abd El-Hamid EM, Taha OT, Elbahie AM. Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section. Hypertens Pregnancy. 2020 Aug;39(3):319-325. doi: 10.1080/10641955.2020.1768268. Epub 2020 May 18.
- Takmaz T, Ozcan P, Sevket O, Karasu AFG, Islek SH, Halici BNA. Less Blood Loss by Earlier Oxytocin Infusion in Cesarean Sections? A Randomized Controlled Trial. Z Geburtshilfe Neonatol. 2020 Oct;224(5):275-280. doi: 10.1055/a-1108-2017. Epub 2020 Mar 2.
- Bahadur A, Khoiwal K, Bhattacharya N, Chaturvedi J, Kumari R. The effect of intrauterine misoprostol on blood loss during caesarean section. J Obstet Gynaecol. 2019 Aug;39(6):753-756. doi: 10.1080/01443615.2019.1581743. Epub 2019 Apr 22.
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
追加の関連 MeSH 用語
その他の研究ID番号
- 20.5.2021-E.16677
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。