ISRCTN74746075已完成未知
Accuracy of a rapid intrapartum test for maternal group B streptococcal colonisation and its potential to reduce antibiotic usage in mothers with risk factors
Queen Mary, University of London (QMUL)0 个研究点目标入组 1,625 人开始时间: 2015年4月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,625
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35027057/ (added 18/01/2022) 2022 Funder report results in https://pubmed.ncbi.nlm.nih.gov/35195519/ (added 24/02/2022)
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 26/04/2018:
- •Presence of one or more of the following risk factors will define inclusion of the mother and baby into the study:
- •1. Previous baby with early or late onset neonatal GBS disease as reported by the mother and documented in the maternal notes.
- •2. GBS bacteriuria during current pregnancy, as documented in the maternal notes, irrelevant of whether the GBS bacteriuria was treated at the time of diagnosis with antibiotics.
- •3. GBS colonisation of the vagina and/or rectum (determined from a vaginal/rectal swab) in current pregnancy, as documented in the maternal notes.
- •4. Preterm labour (<37 weeks’ gestation), with intact membranes or rupture of membranes of any duration, whether suspected, diagnosed or established.
- •5. Maternal pyrexia (>38°C) observed at any point in labour, including clinically suspected/confirmed chorioamnionitis
- •Previous inclusion criteria:
- •Presence of one or more of the following risk factors will define inclusion of the mother and baby into the study:
- •1. The mother has delivered a previous baby who developed neonatal GBS disease (early or later onset), as reported by the mother and documented in the maternal notes
- •2. GBS bacteriuria during the current pregnancy, as documented in the maternal notes, irrelevant of whether the GBS bacteriuria was treated at the time of diagnosis with antibiotics
- •3. GBS colonisation of the vagina and/or the rectum (determined from a recto/vaginal swab) in current pregnancy, as documented in the maternal notes
- •4. Maternal pyrexia (>38°C) observed at any point in labour, or clinically suspected/confirmed chorioamnionitis
- •5. Preterm labour with prelabour rupture of membranes of any duration
- •6. Preterm labour if there is suspected or confirmed intrapartum rupture of membranes lasting more than 18 hours
排除标准
- •Current participant exclusion criteria as of 01/05/2018:
- •Those who do not have any of the risk factors associated with an increased risk of being colonised by GBS
- •Previous participant exclusion criteria as of 26/04/2018:
- •1. Aged under 16 years
- •2. Women in labour at a gestation age of <24 weeks
- •3. Women who, on arrival at the maternity unit, are already in second stage labour or who are likely to deliver their baby imminently
- •4. Women whose baby is known to have died in utero or who has a congenital anomaly incompatible with survival at birth
- •5. Women having an elective Caesarean delivery, which will be performed even if presenting in labour
- •Previous participant exclusion criteria:
- •Those who do not present with any of the risk factors associated with an increased risk of being colonised by GBS
研究者
相似试验
已完成
不适用
Screening programme for pre-eclampsiaSpecialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicinePregnancy and ChildbirthPre-eclampsiaISRCTN83611527Delegated to University College London Comprehensive Clinical Trials Unit (UCL CCTU) by Kings College London16,747
已完成
不适用
Evaluating screening strategies for identifying undiagnosed COPD in Brazil: a Breathe Well projectISRCTN11377960ABC Medical School1,201
已完成
不适用
Intrapartum Rapid GBS Testing in Patients Presenting With Threatened Preterm LaborGroup B StreptococcusNCT02511444MemorialCare Health System342
已完成
不适用
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)Term LabourNCT03409146GE Healthcare80
已完成
不适用
Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.Pregnancy RelatedDiagnosticEmergenciesPelvic PainMetrorrhagiaNCT03250884Rennes University Hospital200