跳至主要内容
临床试验/CTRI/2026/03/106092
CTRI/2026/03/106092Not Applicable不适用

Evaluation Of Predictive Accuracy and Clinical Utility of Phosphorylated Insulin Like Growth Factor Binding Protein-1 In Suspected Preterm labor.

JAWHARLAL NEHRU MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月28日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
60
试验地点
1

研究概览

简要总结

Preterm labor is a major contributor to neonatal illness and mortality, particularly in developing countries. Women presenting with symptoms of threatened preterm labor often require hospitalization and treatment; however, many do not deliver preterm. This results in unnecessary interventions, increased healthcare costs, and psychological stress.

Phosphorylated insulin-like growth factor binding protein-1 (phIGFBP-1) is a biochemical marker released from the decidua when separation of fetal membranes begins prior to labor. Its detection in cervical secretions may help identify women at true risk of imminent preterm delivery.

The present study aims to evaluate the predictive accuracy and clinical utility of bedside phIGFBP-1 testing in pregnant women between 28 and 37 weeks of gestation presenting with symptoms of threatened preterm labor and intact membranes. Participants will be tested using a rapid immunoassay kit and followed to determine delivery outcomes, particularly delivery within seven days of testing.

The findings of this study may help determine whether phIGFBP-1 can serve as a reliable tool to guide clinical decision-making, reduce unnecessary hospital admissions and interventions, and improve maternal and neonatal outcomes in a tertiary care setting.

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 women between gestational age between 28 weeks to 37 weeks Presenting with symptoms of threatened preterm labor(i.e regular uterine contractions occurring every 10ish or more frequent, pelvic pressure, low dull backache, vaginal spotting, feeling of abdominal tightening) intact membranes at the time of testing Cervical dilatation less tha 3cm on initial assessment Willingness to provide informed consent.

排除标准

  • Ruptured membranes( Confirmed or suspected premature rupture of membranes) Active vaginal bleeding or placenta previa Cervical dilatation greaterthan 3 cm or established labor Known fetal anomalies or Intrauterine fetal demise Any condition requiring immediate delivery( e.g. severe preeclampsia, fetal distress) Unwillingness to provide consent.

研究者

发起方
JAWHARLAL NEHRU MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr TANISHQA DEEPAK KADU

JAWAHARLAL NEHRU MEDICAL COLLEGE

研究点 (1)

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