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临床试验/CTRI/2024/02/062994
CTRI/2024/02/062994已完成不适用

Estimation of fetal weight in term singleton pregnancy by various clinical methods and its correlation with actual birth weight

Dr Monika Dinkar1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2024年2月26日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
385
试验地点
1
主要终点
1.To compare the difference in mean percentage error in estimation of fetal weight against actual weight, between clinical and USG methods.

研究概览

简要总结

This study was undertaken to evaluate the accuracy of various clinical methods for fetal weight estimation in comparison with the actual birth weight and secondarily compare the accuracy with ultrasound-based Hadlock’s formula, given the critical role of fetal weight in obstetric decision-making and the limited availability of ultrasound in resource-constrained settings. A prospective observational study was conducted on 385 term singleton pregnancies (37–40 weeks) with cephalic presentation and no complicating fetal or maternal conditions. Estimated fetal weights were calculated using Johnson’s, Dare’s, and Kongnyuy-Mbu’s clinical formulas, as well as Hadlock’s ultrasound method, and compared with actual birth weight post-delivery.

The actual mean birth weight was 3117.02 ± 323.89 g. Hadlock’s method demonstrated the highest accuracy (mean absolute percentage error [APE]: 5.60 ± 4.97%) and the strongest correlation with actual weight (ICC = 0.72). Among clinical methods, Kongnyuy-Mbu’s formula performed best (APE: 5.89 ± 5.41%, ICC = 0.77), followed by Dare’s and Johnson’s. All methods showed significant correlation with actual birth weight (p < 0.001). Within ±10% of actual birth weight, Kongnyuy-Mbu’s (83.4%) and Hadlock’s (83.1%) methods were most accurate. Bland-Altman analysis confirmed good agreement across all methods.

The findings affirm that while ultrasound remains the gold standard, clinical methods—especially Kongnyuy-Mbu’s—can serve as reliable and practical alternatives in settings lacking ultrasound access, offering substantial clinical utility for fetal weight estimation in routine antenatal care.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Singleton pregnancy
  • Cephalic presentation
  • Live foetus
  • Gestational age 37-40 weeks
  • Agrees to follow-up weekly (at 36 weeks and onwards).

排除标准

  • Multiple gestation
  • Anomalous foetus
  • Non- cephalic presentation
  • Intrauterine foetal death
  • Presence of coexisting fibroids, ovarian cysts
  • Already diagnosed liquor abnormalities.

结局指标

主要结局

1.To compare the difference in mean percentage error in estimation of fetal weight against actual weight, between clinical and USG methods.

时间窗: At the time of recruitment

2. To assess the accuracy and degree of correlation of estimated fetal weight by clinical methods with actual birth weight in term pregnancy.

时间窗: At the time of recruitment

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Dr Monika Dinkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Monika Dinkar

Kasturba Medical College

研究点 (1)

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