跳至主要内容
临床试验/CTRI/2021/04/032988
CTRI/2021/04/032988尚未招募不适用

A Comparative Study Of Selected Outcomes Of Treatment With Ursodeoxycolic Acid (UDCA) Vs UDCA+ Phototherapy In Patients With Intrahepatic Cholestasisof Pregnancy - Randomized Control Trial

Armef Forces Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月25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
40
试验地点
1
主要终点
additional benefit of Phototherapy in treatment of IHCP

研究概览

简要总结

Intrahepatic cholestasis of pregnancy is a reversible form of hormonally triggered cholestasis that typically develops in genetically predisposed individuals in late pregnancy. The aim of treatment is the reduction of serum bile acid levels in order to prolong pregnancy and reduce both fetal risks and maternal symptoms. Ursodeoxycholic acid (UDCA) not only reduces maternal pruritus but to also improves fetal prognosis.Both narrowband (NBUVB) and broadband (BBUVB) ultraviolet B light phototherapy are considered safe options in pregnancy. Phototherapy to the skin with ultraviolet (UV) light B is used by some clinicians to treat the pruritus of cholestasis. UVB has been variably helpful in IHCP.

My aim is to compare the selected outcomes of treatment with URSODEOXYCHOLIC ACID (UDCA) vs UDCA+PHOTOTHERAPY in patients with Intrahepatic Cholestasis of Pregnancy

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • All ANC cases with IHCP.

排除标准

  • Women with pruritic skin diseases and other liver pathologies wh are already on treatment for IHCP Lethal fetal anomalies.

结局指标

主要结局

additional benefit of Phototherapy in treatment of IHCP

时间窗: at baseline and weekly till delivery

次要结局

  • 5D Pruritus Scale for assessment of Pruritus(Lab Parameters)

研究者

发起方
Armef Forces Medical College
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验