Critical evaluation of 3 hour GTT in predicting adverse pregnancy outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- To assess the diagnostic accuracy of 3-hour GTT in identifying Gestational Diabetes Mellitus, To evaluate association between abnormal 3hour GTT results and adverse pregnancy outcomes such
研究概览
简要总结
Recruitment and Enrolment-Eligible participants will be identified during routine antenatal visits
between 24 and 28 weeks of gestation. They will be provided with detailed information about the study,
including its purpose, procedures, risks, and benefits. Written informed consent will be obtained from those
who agree to participate, Baseline Data Collection-At enrolment, the following baseline information will be recorded using a
structured questionnaire and medical records. Maternal demographic data (age, parity,). Medical and obstetric
history (previous GDM, hypertension, etc.), Family history of diabetes, Body mass index (BMI), Blood pressure,
Any concurrent medications or comorbidities, 3-Hour OGTT Procedure-Participants will be instructed to fast overnight (8–12 hours). On arrival, a
fasting venous blood sample will be collected. Participants will then consume a 75g glucose solution(depending on national guidelines). Blood samples will be drawn at 1 hour, 2 hours, after glucose intake. All samples will be analysed using standardized laboratory methods to ensure consistency.
Antenatal Follow-up-Participants will continue with routine antenatal visits. Study investigators will
monitor: -Compliance with GDM management. Any maternal complications (e.g., preeclampsia,
polyhydramnios, infections). Ultrasound findings (fetal growth, amniotic fluid index, etc.). Delivery and
Outcome Data Collection. At delivery, data will be collected from hospital records including: Mode of delivery
(normal, assisted, caesarean). Gestational age at delivery. Maternal complications during labour and
postpartum
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women aged 18 years and above attending antenatal care, Singleton pregnancy confirmed by ultrasound, Gestational age between 24 to 28 weeks, Undergoing 3-hour OGTT as a routine antenatal screening.
排除标准
- •Multiple gestations, Maternal age below 18, Pre-existing Diabetes Mellitus, Inability to provide informed consent or participate in follow-up assessments,Gestational age outside the range of 24 to 28 weeks at the time of GTT, known Chronic kidney disease, Cushing’s syndrome, Uncontrolled thyroid disorders, Plan to deliver outside the study centre.
结局指标
主要结局
To assess the diagnostic accuracy of 3-hour GTT in identifying Gestational Diabetes Mellitus, To evaluate association between abnormal 3hour GTT results and adverse pregnancy outcomes such
时间窗: To assess the diagnostic accuracy of 3-hour GTT in identifying Gestational Diabetes Mellitus, To evaluate association between abnormal 3hour GTT results and adverse pregnancy outcomes such | as Macrosomia, preterm birth, preeclampsia, caesarean delivery, To compare the pregnancy outcomes of women to normal OGTT results to those of abnormal results, To investigate maternal characteristics (e.g.- BMI, Family history) that may influence 3-hour GTT and adverse pregnancy outcomes, To explore neonatal outcomes such as NICU admission, Respiratory distress in relation to maternal GTT results
as Macrosomia, preterm birth, preeclampsia, caesarean delivery, To compare the pregnancy outcomes of women to normal OGTT results to those of abnormal results, To investigate maternal characteristics (e.g.- BMI, Family history) that may influence 3-hour GTT and adverse pregnancy outcomes, To explore neonatal outcomes such as NICU admission, Respiratory distress in relation to maternal GTT results
时间窗: To assess the diagnostic accuracy of 3-hour GTT in identifying Gestational Diabetes Mellitus, To evaluate association between abnormal 3hour GTT results and adverse pregnancy outcomes such | as Macrosomia, preterm birth, preeclampsia, caesarean delivery, To compare the pregnancy outcomes of women to normal OGTT results to those of abnormal results, To investigate maternal characteristics (e.g.- BMI, Family history) that may influence 3-hour GTT and adverse pregnancy outcomes, To explore neonatal outcomes such as NICU admission, Respiratory distress in relation to maternal GTT results
次要结局
未报告次要终点
研究者
Dr Akshaya Suresh
Kasturba Medical College, Manipal