Prospective observational study for prediction of pre-eclampsia at 11 to 14 weeks of gestation using mean arterial pressure, uterine artery doppler and pregnancy-associated plasma protien-A.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Increased chances of development of pre-eclampsia are seen with PAPP-A values less than 0.5 MOM at 11 to 14 weeks,High mean arterial pressure increases the risk of pre-eclampsia, Abnormal uterine artery pulsatility index values have higher risk for development of pre-eclampsia.
研究概览
简要总结
Primary objective of this study is prediction of development of pre-eclampsia (early or late onset) at 11 to 14 weeks of gestation using mean arterial pressure, uterine artery pulsatility index and PAPP-A
Secondary objective of this study is prediction of severity of pre-eclampsia, early or late onset pre-eclampsia, fetal growth restriction, neonatal complications.
The study is a single center prospective observational study. The study will be conducted in the outpatient and inpatient departments of obstetrics and gynecology in Bhaktivedanta hospital, Mira Road east, Thane. The study duration is 2 Year. The study will be conducted among pregnant females who visited the outpatient department (OPD) or admitted to the inpatient department (IPD) of obstetrics and gynecology department in Bhakti Vedanta hospital, Mira Road east, Thane. The study participants will be recruited based on the inclusion criteria. First 96 pregnant women will be recruited as per the inclusion criteria at 11 to 14 weeks of gestation. A Detailed informed consent will be taken. Data will be collected from the history taking, general examination findings, routine investigations and current case records of pregnant women who are getting registered. Details will be obtained starting from the Antenatal visit at 11 to 14 weeks till the patient is delivered in our institute.
Mean arterial pressure >106 mmhg will be considered a predictive factor for pre-eclampsia and other complications like FGR.
Serum PAPP-A values <0.5 MOM will be considered as a predictor for development of pre-eclampsia
Uterine artery pulsatility index >95th centile for that gestational age will be used to predict pre-eclampsia in recruited subjects.Data analysis will be done using the SPSS (Statistical package for the social science) version 23 for window. A probability value of 0.05 was accepted as the level of statistical significance. Sample size for this study is 96 cases.
The primary outcome for this study is increased chances of development of pre-eclampsia are seen with PAPP-A values < 0.5 MOM at 11 to 14 weeks, high mean arterial pressure increases the risk of pre-eclampsia, abnormal uterine artery pulsatility index values have higher risk for development of pre-eclampsia.
Thesecondary outcome for this study is assessment of severity of pre-eclampsia, association of the time of development of pre-eclampsia, correlation of fetal growth restriction with low PAPP-A values and high uterine artery pulsatility index, evaluation of neonatal complications such as apgar score, birth weight and requirement of nicu admission in patients of pre-eclampsia.
The inclusion criteria includes Pregnant females of age 18 to 45 years who are registered and planning to deliver at bhakti Vedanta hospital and willing for regular antenatal visits and willing to participate in study.
The exclusion criteria includes patients with fetal chromosomal abnormality, patients diagnosed with multifetal pregnancy, patients having chronic hypertension or diagnosed with pre-eclampsia in previous pregnancy, patients having renal disease, obesity (BMI>30), autoimmune disorder like SLE, not willing to participate in study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant females of age 18 to 45 years who are registered and planning to deliver at bhakti Vedanta hospital and willing for regular antenatal visits.
- •Willing to participate in study.
排除标准
- •Patients with fetal chromosomal abnormality.
- •Patients diagnosed with multifetal pregnancy.
- •Patients having chronic hypertension or diagnosed with pre-eclampsia in previous pregnancy.
- •Patients having renal disease obesity (BMI more than 40) Autoimmune disorder like SLE Not willing to participate in study.
结局指标
主要结局
Increased chances of development of pre-eclampsia are seen with PAPP-A values less than 0.5 MOM at 11 to 14 weeks,High mean arterial pressure increases the risk of pre-eclampsia, Abnormal uterine artery pulsatility index values have higher risk for development of pre-eclampsia.
时间窗: at 11 to 14 weeks, at 20 to 34 weeks, at the time of delivery
次要结局
- Assessment of severity of pre-eclampsia using PAPP-A, mean arterial pressure and uterine artery pulsatility index values,Association of the time of development of pre-eclampsia i.e., early or late onset with PAPP-A values, mean arterial pressure and uterine artery pulsatility index,Correlation of fetal growth restriction with low PAPP-A values and high uterine artery pulsatility index,Evaluation of neonatal complications such as apgar score, birth weight and requirement of nicu admission in patients of pre-eclampsia
研究者
Dr Gargee Sharma
BhaktiVedanta Hospital and Research Institute
