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临床试验/CTRI/2025/03/082994
CTRI/2025/03/082994尚未招募不适用

Maternal and Fetal outcome in pregnancies complicated by portal hypertension. An observational study.

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
To assess the maternal and fetal outcomes in pregnancies complicated by portal hypertension

研究概览

简要总结

Pregnant women with a diagnosis of portal hypertension, based on a history of GI bleed, jaundice, and ascites, presence of varices on endoscopy, presence of collaterals in spleno-portal axis and dilated portal vein, i.e., more than 13 mm on Doppler ultrasound8, will be identified from the admission records of the labour ward, antenatal wards, HDU, and the Obstetric Intensive Care Unit. Details of those who had undergone a portosystemic shunt surgery with/without splenectomy for portal hypertension and its complications will be recorded. The cause of portal hypertension will be recorded as – Cirrhotic or Non-cirrhotic. The non-cirrhotic will be further categorized into NCPF and EHPVO.  If the cause of cirrhosis is known that also will be collected.

Demographic details including age during pregnancy, parity, age at the time of diagnosis, clinical details such as etiology of portal hypertension, duration and course of the disease and management including medication, endoscopic findings, details of endoscopic or open surgery, sclerotherapy and the treatment received during pregnancy will be recorded. Medical complications like hematemesis, any massive bleed, anemia, severe thrombocytopenia, need for blood products, or any decompensation of hepatic function (clinical and/ or biochemical), obstetric complications during pregnancy including abortions, antepartum hemorrhage, hypertensive disorder of pregnancy and fetal growth restriction; the timing and mode of delivery, any peripartum complications such as postpartum hemorrhage, and the neonatal outcomes like birth weight, neonatal intensive care unit (NICU) admissions and deaths will be collected and analysed. The details of any complications till discharge form the hospital will be recorded.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Portal hypertension diagnosed before or during pregnancy, irrespective of the cause.

排除标准

  • Age < 18 years.

结局指标

主要结局

To assess the maternal and fetal outcomes in pregnancies complicated by portal hypertension

时间窗: Outcomes are assessed after delivery.

次要结局

  • 1. To compare the pregnancy outcome in women with cirrhotic, non-cirrhotic portal fibrosis (NCPF) & extrahepatic portal vein obstruction (EHPVO).(2. To assess the risk factors associated with variceal bleeding during pregnancies, among women with portal hypertension.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bodicherla Bhuvana Sai

JIPMER

研究点 (1)

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