Vaginal Misoprostol to Improve the Neonatal Respiratory Outcome
Vaginal Misoprostol Before Elective Cesarean Section to Improve Neonatal Respiratory Outcomes . Randomized Controlled Clinical Study
Project summary:
Objective: To test the hypothesis that administration of vaginal Misoprostol before elective cesarean section will improve the neonatal respiratory outcomes in late preterm and early term neonates through induction of catecholamine surge.
Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two hundred and ninety two women will be randomly allocated to receive either 50 micrograms of Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or receive nothing (control group; n = 146) .
Main outcome measure: Apgar score at 1 and 5 minutes.
調査の概要
詳細な説明
Methodology: After a written informed consent obtained, women who are fitting the inclusion criteria will be randomly allocated using sealed, coded, opaque and sequentially numbered envelopes containing computer generated random numbers into either the study group or the control group. For the study group the enrolled women will receive 50 microgram misoprostol vaginally within 60 minutes before CS. For the control group mothers enrolled will receive nothing.
Observation and data collection: Cardiotocographic monitoring will be undertaken after maternal misoprostol administration to detect any evidence of uterine hyperstimulation and fetal distress.
Ritodrine IV will be used as a tocolytic agent in case of uterine tachysystole. 100 mg of ritodrine will be added to 500 ml of 0.5% dextrose, the solution will be administered as following:
5 drops / minute in the 1st 10 minutes. 10 drops / minute in the next 10 minutes then 15 drops / minute . The clinician should adjust the infusion rate so that the pulse rate doesn't exceed 120b/min and lung bases are free of crepitations.
The surgical and anesthetic teams will be in a state of complete readiness for the ECS from the time of maternal misoprostol administration after enrollment. Details on maternal fluid-electrolyte status during ECS will be recorded as maternal fluid overload is reported to be associated with respiratory distress in the newborn. (SinghiS,Chookang E;1984) blood loss during and 1 hour after the operation will be estimated.
Maternal data: Patient name, hospital number, age, parity, gestational age, any medical disorder and indication of CS.
Neonatal observations: delivery room care details will be noted, neonatal heart rate, respiratory rate, and signs of respiratory distress- for example, grunting, chest wall retractions, nasal flaring- will be recorded hourly in the postnatal ward for eight hours and once only at 24 hours of age after delivery. Management of a neonate with respiratory distress (defined as respiratory rate at rest.60/min and/or signs of respiratory distress) will be left to the neonatal team. Severity of illness, provisional and final diagnosis, and outcome (death/discharge home/transfer to other hospital) will be recorded if any neonate would be admitted to the neonatal intensive care unit for respiratory distress.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ahmed Makhlouf, Professor
- 電話番号：0882414616
- メール：amakhloufsalama@yahoo.com
研究場所
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Assiut、エジプト
- 募集
- women health center,Assiut university
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コンタクト：
- Ahmed Makhlouf, Professor
- 電話番号：0882414616
- メール：amakhloufsalama@yahoo.com
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
All pregnant women who are planned for elective (planned& pre labor) cesarean section at 34 -37 weeks gestation.
Exclusion Criteria:
- Pregnancies with known fetal malformation/s or chromosomal aberrations.
- Presence of absolute contraindication for use of misoprostol.(i.e known hypersensitivity to the drug)
- Women before 34 and after 37 weeks gestation .
- Non reassuring cardiotocogram immediately before recruitment.
- multiple pregnancies.
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：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：study group
For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS
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他の名前：
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介入なし：control group
For the control group mothers enrolled will receive nothing.
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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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1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.
時間枠：During the first 24 hours of life.
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The number of neonates who need Neonatal Intensive Care Unit admission in each study group
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During the first 24 hours of life.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ahmed Makhlouf, professor、women health center,Assiut university,Assiut,Egypt
出版物と役立つリンク
一般刊行物
- Motaze NV, Mbuagbaw L, Young T. Prostaglandins before caesarean section for preventing neonatal respiratory distress. Cochrane Database Syst Rev. 2013 Nov 11;(11):CD010087. doi: 10.1002/14651858.CD010087.pub2.
- Singh M, Patole S, Rane A, Naidoo D, Buettner P. Maternal intravaginal prostaglandin E2 gel before elective caesarean section at term to induce catecholamine surge in cord blood: randomised, placebo controlled study. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F131-5. doi: 10.1136/adc.2002.025957.
- Hansen AK, Wisborg K, Uldbjerg N, Henriksen TB. Risk of respiratory morbidity in term infants delivered by elective caesarean section: cohort study. BMJ. 2008 Jan 12;336(7635):85-7. doi: 10.1136/bmj.39405.539282.BE. Epub 2007 Dec 11.
- Yang JY, Fang LJ, Tsou Yau KI. Labor pain before elective cesarean section reduces neonatal respiratory distress. Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi. 1997 Jan-Feb;38(1):38-43.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
- assiut university women health
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
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