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临床试验/CTRI/2025/11/097515
CTRI/2025/11/097515尚未招募不适用

Correlation of onset of preeclampsia in hypertensive disorders in pregnancy, admitted for delivery by FOGSI HDP-Gestosis score in a tertiary care hospital: a case control study

Manoj TP1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
• To assess the correlation using FOGSI[Federation of Obstetrics and Gynecological societies of India] HDP-Gestosis score for development of preeclampsia in patients with hypertensive disorders in pregnancy versus normotensive women.

研究概览

简要总结

HDPGestosis score is a simplified dynamic feasible quantification of maternal clinical risk factors for effective screening of Hypertensive Disorders in Pregnancy HDP gestosis score is a high risk scoring system score 1 to 3 for the development of preeclampsia

Hypertensive disorders in pregnancy are the spectrum of disorders ranging from already existing chronic hypertension in the index pregnancy to complex multisystem disorder like preeclampsia leading to the complications like eclampsia HELLP syndrome Acute renal failure Pulmonary edema Stroke and Left ventricular failure Severe preeclampsia and these complications are the major causes of maternal and perinatal morbidity and mortality Among all maternal deaths 19 percent of deaths are due to hypertension in pregnancy despite the phenomenal numbers of patients seeking hospital based delivery care substantial gap is identified in the quality of care executed

Primary objective

To assess the correlation using FOGSI Federation of Obstetrics and Gynecological societies of India HDP Gestosis score for development of preeclampsia in patients with hypertensive disorders in pregnancy versus normotensive women

Secondary objective

To evaluate the fetomaternal outcomes in Hypertensive diseases in pregnancy HDP

Inclusion Criteria

·       Antenatal women presenting with hypertensive disorders in pregnancy with blood pressure recordings more than or equal to 140 by 90 mmHg at the time of admission for delivery or those already on antihypertensive medications with or without controlled blood pressure 140 by 90 mmHg will be included as cases upon admission

·       At the same time antenatal women with normal Blood Pressure admitted for delivery will be  taken as controls

·       Patients who are willing to give consents will be included

 Exclusion Criteria

·       Any women admitted for delivery in the labor room and are not willing to give consent

 Data collection procedure

·       Permission from the institutional ethics committee and the university clearance will be taken

·       Meeting and the rapport building with the study participants

·       200 women with Hypertensive disorders in pregnancy whose BP readings are more than or equal to 140 by 90 mmHg admitted in labor room for delivery will be enrolled as cases into the study and 200 women admitting and delivering during same period and found to have normal BP readings will be enrolled as controls

·       The patients are provided with the study information sheet and consent form and will be explained about the relevant details about the study in a language best understood by them

·       Informed written consent will be obtained after explaining about the purpose nature and process of the study and then data collection will be started

·       The detailed history and through physical and obstetric examination along with the relevant investigations will be done risk factors if any will be noted

·       The information pertaining to the study such as age parity gravida residence family history and BMI details will be obtained from the patients

·       Routine antenatal investigations will be collected from the patients by their case records Apart from the routine antenatal investigations this study necessitates serum lipid profile for scoring hence the sample for the lipid profile will be collected

·       History of pre gestational and gestational diabetes mellitus chronic hypertension mental disease chronic kidney disease history of HDP in previous pregnancy and history of diagnosed autoimmune disease like SLE or APLA syndrome MAP thrombophilia will be collected during their admission to the labor room for delivery

·       Antenatal and intranatal details will be noted

·       Maternal and fetal monitoring will be performed as per standard guidelines

Maternal and fetal outcomes in terms of morbidity and mortality will be noted

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Antenatal women diagnosed with hypertensive disorders in pregnancy whether presenting with blood pressure readings more than or equal to 140 by 90 mmHg at the time of admission for delivery or those already on antihypertensive medications with controlled blood pressure less than 140 by 90 mmHg will be included as cases upon admission to the labor room Antenatal women with normal Blood Pressure admitted for delivery will be taken as controls Patients who are willing to give consents will be included.

排除标准

  • Any women admitted for delivery in the labor room and are not willing to give consent.

结局指标

主要结局

• To assess the correlation using FOGSI[Federation of Obstetrics and Gynecological societies of India] HDP-Gestosis score for development of preeclampsia in patients with hypertensive disorders in pregnancy versus normotensive women.

时间窗: 28 weeks to 42 weeks

次要结局

  • • To evaluate the feto-maternal outcomes in Hypertensive diseases in pregnancy (HDP).(28 weeks to 42 weeks)

研究者

发起方
Manoj TP
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Manoj TP

Jawaharlal Nehru Medical College, Belagavi

研究点 (1)

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