Frequency of Performing Umbilical Artery Doppler in the Third Trimester in High Risk Pregnancy A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Neonatal admission to r intensive care unit within the first 24 hours
研究概览
简要总结
The aim of the current study was to produce a high quality evidence on the best frequency of performing umbilical artery Doppler for high risk pregnant women in the third trimester.
详细描述
Nowadays, high risk pregnancy forms a significant increasing proportion of any pregnant population, according to some authors up to 50% of all pregnancies would have the label of high risk pregnancies.
At present, it is recommended that high risk pregnancies, thought to be at risk of placental insufficiency should be monitored with Doppler studies of the umbilical artery. Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of intrauterine growth restriction.
The purpose of umbilical artery Doppler surveillance is to predict fetal academia thereby allowing timely delivery prior to irreversible end-organ damage and intrauterine fetal death.
According to a Cochrane Pregnancy and Childbirth Group's systematic review and meta-analysis, in which Published and unpublished randomised and quasi-randomised trials evaluating the effects of one or more described antenatal fetal surveillance regimens were searched, the optimal frequency of umbilical artery Doppler surveillance is unclear.
Our randomized controlled study was conducted on patients with high risk pregnancies at their third trimester who attended Ain Shams University Maternity Hospital. A total of 292 high risk pregnant women fulfilling the inclusion criteria were selected by random sampling and divided between two groups with 146 patients in each group. Group I underwent Doppler every other week and Group II underwent Doppler once weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding of the patients or staff in this study is not generally feasible. However, the measured outcomes in this study are objective and are unlikely to be biased by lack of blinding.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •I-Singleton pregnancy. II-In the third trimester (starting from 28 weeks of gestation till the time of delivery), Gestational age will be determined by the date of the last menstrual period and early ultrasound.
- •III-Patient considered as high-risk pregnancies will be included in this study.
- •The following will be considered as high-risk status:
- •Previous obstetric history of preeclampsia or eclampsia, abruptio placenta, intra-uterine growth restriction or still birth.
- •Pre-existing medical disorders like:
- •Pregestational diabetes (Ang et al., 2006)
- •Renal diseases (such as nephrotic syndrome, chronic renal failure, renal transplant and hemodialysis) (Divon and Ferber, 2012).
- •Autoimmune diseases (such as systemic lupus erythromatosis and rheumatoid arthritis) (Divon and Ferber, 2012).
- •Acquired thrombophilias (such as antiphospholipid syndrome). On the other hand, inherited thrombophilias (such as protein C or S deficiency) are not associated with IUGR (Reeves and Galan, 2012).
- •Chronic maternal hypoxemia due to pulmonary disease (such as uncontrolled asthma, chronic obstructive pulmonary disease and cystic fibrosis), cardiac disease (such as cyanotic heart disease) or hematologic disorders (such as severe anemia, sickle cell anemia and β-thalassemia) (Baschat et al., 2012).
- •Current preeclampsia or pregnancy-induced hypertension (PIH). PIH is diagnosed in women whose blood pressure reaches 140/90 mm Hg or greater for the first time after midpregnancy, but proteinuria is not identified. Preeclampsia is best described as pregnancy-specific syndrome that can affect virtually every organ system.It is much more than simply gestational hypertension with proteinuria (Cunningham et al, 2010).
- •IV- Obtaining valid informed consent to participate in the study
排除标准
- •I-Patients with congenital anomaly of the fetus. As this will affect fetal outcome with no effect of Doppler changes.
- •II- Patients with multiple gestations. As they have different growth pattern. III- Patients with unconfirmed Gestational age due to lack of sure reliable date and absent early trimesteric scan. As we cannot diagnose small for gestational age without sure date.
- •IV- Withdrawal of consent.
研究组 & 干预措施
Bi-Weekly Umbilical Artery Doppler
will undergo Doppler every other week
干预措施: Umbilical artery Doppler (Diagnostic Test)
Weekly Umbilical Artery Doppler
will undergo Doppler every week
干预措施: Umbilical artery Doppler (Diagnostic Test)
结局指标
主要结局
Neonatal admission to r intensive care unit within the first 24 hours
时间窗: first 24 hours of life
Neonatal admission to special care and/or intensive care unit within the first 24 hours
次要结局
- Apgar score less than seven at five minutes(5 minutes)
- Induction of labour(24 hours)
- Stillbirth(at delivery)
- Neonatal death(28 days)
- Fetal acidosis(at delivery)
- Preterm labour(37 weeks)
- Gestational age at birth(28 weeks)
- Infant respiratory distress syndrome(24 hours)
- Hypoxic ischaemic encephalopathy(96 hours)
- Intraventricular haemorrage(96 hours)
- Necrotizing enterocolitis(96 hours)
研究者
Mohamed Hamed Salama
Lecturer of Obstetrics and Gynaecology
Ain Shams University