NCT00259519终止不适用
Effects of Intentional Delivery After Preterm and Prelabor Rupture of Membranes Between 32 and 35 Weeks of Gestation: A Multicentre Randomized and Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 152
- 试验地点
- 19
- 主要终点
- Length of Stay in hospital
研究概览
简要总结
Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.
The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated with PPROM-related complications without increasing the morbidity associated with a shortened pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with recent PPROM between 31 weeks + 6 days and 35 weeks + 6 days (estimated gestational age based on an ultrasound examination before 18 weeks of gestation), not in labour 24 hours after admission*, will be considered eligible for the study provided the following inclusion criteria (*For patients transferred from a remote level 2 centre to one of the participating sites within the first hours after PPROM, the onset of the 24-hour screening period will be the time of admission in the centre of origin. Patients in Group A will be given their first dose of antenatal steroids before the transfer)
- •Single and otherwise uncomplicated pregnancy
- •Recent history (less than 48 hours) of leaking with the two followings within 24 hours after primary medical assessment: Documentation of fluid from the vagina and Positive Fern test, or positive Nitrazine test, or Positive ACTIM PROM test
- •Antenatal steroids course initiated after the rupture for women with PPROM between 31 + 6 and 33 + 6 weeks
- •Normal fetal heart rate trace using an external ultrasound transducer
- •Written informed consent obtained before inclusion and randomization
排除标准
- •Multiple pregnancy
- •HIV positive mother
- •Active HSV cervical lesions
- •Major fetal anomaly on ultrasound examination performed after admission
- •Intrauterine growth restriction estimated on ultrasound below the 5th percentile or preeclampsia
- •Placenta abruption present at the time of the diagnosis of PPROM or occurring within the first 24 hours after rupture
- •Clinical chorioamnionitis existing before or at the time of the diagnosis of PPROM or developing within the first 24 hours after rupture
- •Non-reassuring fetal testing present at the time of the diagnosis of PPROM or occurring within the first 24 hours after the rupture. It implies that expected criteria for standard fetal assessment parameters have not been met, including the Non-Stress test and the Biophysical profile Score. This will be diagnosed at the discretion of the attending physician.
- •More generally, any maternal or fetal reason for an immediate delivery, either existing at admission or occurring within the 24 hours after admission.
- •Mother refusal or inability to provide consent
结局指标
主要结局
Length of Stay in hospital
时间窗: time between birth and readiness for discharge
次要结局
- MAIN Score (Morbidity Assessment Index for Newborns)(From birth to discharge)
- Early Onset Neonatal Sepsis(from birth to discharge)
- Clinical and Histological Chorioamnionitis(from birth to discharge)
- Antepartum Length of stay(From diagnosis to delivery)
- C-Section(delivery)
研究者
研究点 (19)
Loading locations...
相似试验
Unknown
1 期
Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-PyrimethamineMalariaNCT03599596University College Hospital, Ibadan136
已完成
3 期
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm DeliveryPreterm BirthNCT01004029AMAG Pharmaceuticals, Inc.1,740
已完成
不适用
Health and Wellness After Preterm BirthPreterm BirthHealth Care UtilizationTobacco UseContraceptive UsageWeight, BirthDepressionNCT05756634Children's Hospital of Philadelphia67
已完成
不适用
The Twin Birth Study: A Trial Comparing Planned Vaginal Birth to Elective Caesarean Section of TwinsTwin PregnancyNCT00187369Sunnybrook Health Sciences Centre2,804
终止
不适用
Routine Early vs Delayed Amniotomy for Preterm Pregnancies: A Randomized Open Label TrialLabor, PrematureNCT03682822The University of Texas Health Science Center, Houston104