跳至主要内容
临床试验/CTRI/2024/06/068803
CTRI/2024/06/068803尚未招募不适用

Comparative study of fetal weight estimation by clinical methods and ultrasound and its correlation with the actual birth weight

Datta Meghe Institute of higher education and research1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6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
200
试验地点
1
主要终点
method in predicting fetal weight and provide insights into their clinical utility in a tertiary

研究概览

简要总结

Accurate estimation of fetal weight is of key importance in the Obstetrician’s  decision-making process in the antepartum and intrapartum management of pregnancy, along with gestational age and adequacy of maternal pelvis, to decide the management of labor and mode of delivery. Accurate estimates are essential, since abnormal fetal growth may be associated with perinatal and maternal risk.

Both low and excessive weights at delivery are associated with an increased risk of newborn complications during labour and puerperium.

Delivery of a macrosomic fetus is associated with prolonged labor and various delivery traumas, including shoulder dystocia, brachial plexus injuries and intrapartum asphyxia, as well as increased maternal risks such as birth canal injuries and postpartum hemorrhage.

World Health Organization (WHO) has recommended that newborns with birth weight less than 2500 grams may be considered to fall in low birth weight categories carrying relatively higher risk of perinatal and neonatal morbidity and mortality. About 80% of neonatal death and 50% of infant deaths occur among these group. These infants are more prone to develop recurrent infection, malnutrition, diabetes, hypertension and neuro developmental handicaps in their life time. Hence low birth weight is an important risk factor for adverse outcome in later life. Therefore estimation of fetal birth weight in intra uterine period happens to be of greater significance in early detection of intra uterine growth restriction and prevention of prematurity.

Management of diabetic pregnancy, vaginal birth after a previous caesarean section, and intrapartum management of foetuses presenting by the breech will be greatly influenced by estimated fetal weight.

Clinical methods of fetal weight estimation like Johnson’s formula and Insler’s formula can be used to predict expected fetal weight in low resource settings. Ultrasound is also used for estimation of expected fetal weight . But, it is not easily available in all places offering obstetric care, especially in low resource settings. Fetal weight estimation using ultrasound needs training, expertise and an expensive equipment. In such circumstances clinical methods of estimating fetal weight can aid in obstetric decision making.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Live fetus 2.Term pregnancy (Gestational age of 37-40 weeks) 3.Singleton pregnancy 4.Cephalic presentation 5.Known last menstrual period or ultrasound scan with confirmed expected date of delivery.

排除标准

  • 1.Multiple gestation 2.Non- cephalic presentation 3.Intrauterine fetal death 4.Presence of coexisting fibroids or adnexal masses 5.Already diagnosed liquor abnormalities 6.known fetal malformation 7.obesity.

结局指标

主要结局

method in predicting fetal weight and provide insights into their clinical utility in a tertiary

时间窗: The study shall be conducted between 37 to 40 weeks of pregnancy

The primary outcome of this study is to compare the estimated fetal weight obtained from

时间窗: The study shall be conducted between 37 to 40 weeks of pregnancy

clinical methods (Johnson’s formula, Insler’s formula, and McDonald’s measurement of

时间窗: The study shall be conducted between 37 to 40 weeks of pregnancy

symphysio-fundal height) and ultrasound (using Hadlock’s formula) with the actual birth

时间窗: The study shall be conducted between 37 to 40 weeks of pregnancy

weight of the neonate. This comparison will assess the accuracy and reliability of each

时间窗: The study shall be conducted between 37 to 40 weeks of pregnancy

care hospital setting in Central India.

时间窗: The study shall be conducted between 37 to 40 weeks of pregnancy

次要结局

  • accuracy of fetal weight estimation(correlation coefficients)

研究者

发起方
Datta Meghe Institute of higher education and research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Lakkireddy Vaishnavi

Datta Meghe institute of higher education and research

研究点 (1)

Loading locations...

相似试验