CTRI/2024/10/075290招募中不适用
Role of various Cardiotocography characteristics in prediction of fetal acidemia at birth.
Department of Obstetrics and Gynecology,1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年10月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- We intend to study the following parameters of cardiotocography on the study group that is Baseline FHR, Beat to beat variability,Total acceleration area,Total deceleration area,Minimum acceleration depth, Minimum deceleration depth, Maximum deceleration depth, Maximum acceleration depth and correlate to incidence of fetal acidemia.
研究概览
简要总结
- It is a prospective cross sectional study.
- The objectives of the study are
- To assess the relationship between various cardiotocography (CTG) characteristics with cord blood pH level at birth in fetus with abnormal CTG patterns according to FIGO guidelines.
- To derive the prediction model using various CTG characteristics to detect fetal acidemia at birth.
- To assess the correlation between various CTG characteristics with neonatal outcomes.
- Participants will be recruited from in patients presenting to labour ward. A few questions will be asked to collect the socio demographic details and the obstetric details according to proforma. Photographs of the 10 minute suspicious or pathological CTG trace according to FIGO guidelines from last 2 hours CTG trace prior to delivery of the patient in labour ward will be taken and various CTG features like accelerations, acceleration area, decelerations, deceleration area, acceleration to deceleration area ratio, baseline fetal heart rate, variability will be interpretated using strict and unambiguous definitions from FIGO criteria and are used to categorise the CTG recordings into one of the categories normal, suspicious or pathological. The patients having suspicious or pathological CTG trace are recruited. Post delivery of the baby and handing over the baby to pediatrician for post birth care after clamping and cutting the umbilical cord between the two hemostatic clamps, a third clamp is placed on the maternal side of placenta to stabilise the segment of the umbilical cord . Cord arterial blood will be collected from the segment of the umbilical cord for arterial blood gas analysis (ABG) and processed within 10 minutes of collection and correlation of the cord blood pH at birth is made.
- It is standard practice for collection of umbilical cord blood for cord blood pH and does not have any anticipated risks to mother and the baby. The neonates of such mothers will be monitored for requirement of NICU stay. Neonatal outcome will be monitored for neonatal morbidity at discharge or death. A correlation will be made between CTG characteristics and outcome of the neonates. data will be analysed according to statistical methods mentioned and association between abnormal CTG according to FIGO guidelines and strength of association between between CTG characteristics and fetal acidemia determined.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •All consecutive women labouring at ≥ 37 weeks to 41 weeks with a singleton gestation who are admitted in labour ward at department of obstetrics and gynecology, kasturba hospital , with suspicious or pathological CTG pattern (according to FIGO ) atleast 2 hours prior to delivery.
排除标准
- •Patients with gestational age less than 37 week and greater than 41weeks Patients with normal Cardiotocographic(CTG) patterns Pregnancies complicated by congenital anomalies Patients with insufficient CTG recordings less than 10 mins prior to delivery.
- •Maternal infection and fever Elective C section Still birth Patient not willing to consent.
结局指标
主要结局
We intend to study the following parameters of cardiotocography on the study group that is Baseline FHR, Beat to beat variability,Total acceleration area,Total deceleration area,Minimum acceleration depth, Minimum deceleration depth, Maximum deceleration depth, Maximum acceleration depth and correlate to incidence of fetal acidemia.
时间窗: cross sectional study
To derive the prediction model using various CTG characteristics to detect fetal acidemia at birth.
时间窗: cross sectional study
次要结局
- Neonatal outcomes & morbidity like APGAR- 1’, 5’scores, NICU stays in view of morbidities like neonatal encephalopathy, neonatal sepsis, necrotizing enterocolitis.(0, 1 day , 3 days, 7 days)
研究者
DR SAMEERA CHEGU
Kasturba medical college,Manipal
研究点 (1)
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