ISRCTN20131893已完成未知
Randomised controlled trial on the use of synthetic osmotic cervical dilator in induction of labour in comparison to dinoprostone vaginal insert
Birmingham Women’s and Children’s NHS Foundation Trust0 个研究点目标入组 674 人开始时间: 2017年6月2日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 674
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 05/11/2020:
- •1. Women >16 years of age
- •2. Able to provide informed consent
- •3. Singleton pregnancy
- •4. Indication for IoL
- •5. Pregnancy =37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan)
- •6. Living fetus with vertex presentation
- •7. Intact membranes
- •Previous inclusion criteria:
- •1. Women aged 16 years and over
- •2. Understanding and capable to provide informed consent
- •3. Singleton pregnancy
- •4. Indication for IoL
- •5. Pregnancy =37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan at 11-14 weeks)
- •6. Living fetus with vertex presentation
- •7. Intact membranes
- •8. Bishop Score =6 points
排除标准
- •Current exclusion criteria as of 05/11/2020:
- •1. Women already receiving oxytocin
- •2. Diagnosis of fulminant preeclampsia/eclampsia
- •3. Contraindication to Dinoprostone or Dilapan
- •4. If Dinoprostone for loL is non-compliant with local policy
- •5. Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour
- •Previous exclusion criteria:
- •1. Contraindication for vaginal delivery (i.e., placenta previa)
- •2. When labour has already started (defined as regular painful contractions)
- •3. When oxytocin is being administered
- •4. Fulminant preeclampsia/eclampsia
- •5. Clinical signs of uterine, cervical, vaginal or vulval infection (except Group B Streptococcal colonisation)
- •6. Known allergy or contraindication to drug or device ingredients
- •7. Previous uterine body/midline/classical caesarean section (EXCEPT lower segment caesarean section)
- •8. More than one previous caesarean section
- •9. Known uterine abnormality
- •10. Suspected fetal hypoxia (i.e., CTG recording evaluated as abnormal prior to pre-induction initiation)
- •11. Unstable lie
- •12. Active antepartum haemorrhage at the time of induction
- •13. Four or more full-term deliveries
- •14. Known fetal anomalies
研究者
相似试验
进行中（未招募）
1 期
A randomised controlled trial of a Synthetic Osmotic cervical dilator for induction of Labour in comparison to dinoprostone Vaginal insErt:the SOLVE trialInduction of LabourMedDRA version: 20.0Level: PTClassification code 10000154Term: Abnormal labour affecting foetusSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.0Level: LLTClassification code 10054386Term: Fetal heart rate disorderSystem Organ Class: 100000004849MedDRA version: 20.0Level: PTClassification code 10046790Term: Uterine hypertonusSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.0Level: PTClassification code 10013442Term: Disseminated intravascular coagulationSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: PTClassification code 10046820Term: Uterine ruptureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 20.0Level: PTClassification code 10002198Term: Anaphylactic reactionSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: LLTClassification code 10018162Term: Genital oedema femaleSystem Organ Class: 100000004872MedDRA version: 20.0Level: LLTClassification code 10001971Term: Amniotic fluid embolismSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.0Level: LLTClassification code 10028816Term: Nausea and vomitingSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: PTClassification code 10012735Term: DiarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: LLTClassification code 10016492Term: Fetal distress syndromeSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsEUCTR2016-004726-42-GBBirmingham Women's Hospital860
招募中
不适用
on drug interventions to reduce breathlessness in patients with Chronic Obstructive Pulmonary Disease (Emphysema)chronic obstructive pulmonary disease (COPD)BreathlessnessRespiratory - Chronic obstructive pulmonary diseaseACTRN12617000499381Westmead Hospital94
已完成
不适用
A randomised controlled trial for the effect of symptom feedback on help-seeking for mental health issues.Help-seekingMental health issuesPublic Health - Health promotion/educationMental Health - Other mental health disordersACTRN12614000324617The Centre for Mental Health Research, The Australian National University3,372
已完成
不适用
A prospective randomized controlled trial of simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization of upper gastrointestinal endoscopypper gastrointestinal diseasesEndoscopyUpper gastrointestinal diseasesVisualisationTCTR20190501002Faculty of medicine128
招募中
4 期
Randomized controlled clinical trial for the efficacy and safety of Kaihoujian inhalation for acute laryngitisacute laryngitisITMCTR1900002675Wangjing Hospital, China Academy of Chinese Medical Sciences