Prediction of pregnancy outcome in preeclampsia using optic nerve sheath diameter.
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
- Correlation of pregnancy outcome in preeclampsia with optic nerve sheath diameter
研究概览
简要总结
Pre-eclampsia, affecting 2–8% of pregnancies worldwide, is a major cause of maternal and perinatal complications.Early risk identification enables timely diagnosis, early intervention and better management which can reduce associated morbidity and mortality. Therefore, prediction models are being studied to help early identification and timely intervention for an optimal feto-maternal outcome. There is an ongoing quest to look for an economical yet effective alternative.In hypertensive disorders of pregnancy, particularly preeclampsia and eclampsia, raised intracranial pressure (ICP) can occur due to cerebral oedema, leading to potential complications like intracranial hemorrhage and seizures. Its clinically difficult to detect early cerebral edema and raises ICP.
There is a need of some bedside noninvasive, safe method of detection. OPTIC NERVE SHEATH DIAMETER measured by ultrasound can be an important device for prediction of raised ICP with the added
benefit of it being a bedside/ point of care test.
OPTIC NERVE SHEATH DIAMETER has been utilized in various neurological complications. Pré-eclampsia is a complex condition which affects the multiple organ systems, including the central nervous system.
Based on this background, this study is designed to study the pregnancy outcome in women with preeclampsia using optic nerve sheath diameter.
AIM(S) & OBJECTIVE(S)
AIM: To predict the pregnancy outcomes in women with preeclampsia using optic nerve sheath diameter
OBJECTIVE:
To measure and correlate the optic nerve sheath diameter with the pregnancy outcome in women with preeclampsia.
MATERIAL AND METHODS
This study will be conducted in the Department of Obstetrics and Gynecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi.
Type of study: Prospective observational study
Duration of study:18months
Study setting: Department of Obstetrics and Gynecology, and Department of Radiodiagnosis
Vardhman Mahavir Medical College and Safdarjung Hospital,
New Delhi
Study population: All antenatal women meeting the eligibility criteria Inclusion criteria:
- Singleton Pregnancy with period of gestation>28 weeks with preeclampsia
Exclusion criteria:
-
Known neurological disorders (eg epilepsy, intracranial space-occupying lesion, trauma, hydrocephalus)
-
Ocular disease affecting optic nerve (optic neuritis, orbital cellulitis, glaucoma)
-
Chronic renal disease / chronic liver disease not related to pre-eclampsia
-
Long-term Magnesium therapy or diuretics
-
Multiple pregnancy
-
Fetal anomalies
METHODOLOGY
This study titled “PREDICTION OF PREGNANCY OUTCOME IN PRE ECLAMPSIA
USING OPTIC NERVE SHEATH DIAMETER” is a prospective observational study that will be performed on 200 participants over 18 months duration in the Dept of Obstetrics and Gynaecology, VMMC and SJH, New Delhi. All pregnant women will be screened for eligibility as per inclusion and exclusion criteria of the study. Informed consent will be taken. Data collection as per the study performa will be done, the management will be done as per the departmental protocol.
Measurement of –All enrolled women will be followed and pregnancy outcome will be noted in terms of adverse materno-fetal outcomes.
Definition of adverse outcome:
1-Maternal:
• Progression to eclampsia
• ICU admission
• Abruption
• Neurological complications
• Maternal mortality
2-Fetal:
• Preterm birth
• Perinatal mortality
Optic nerve sheath diameter measurement will be done once the patient is planned for termination of pregnancy using ultrasonography machine: ESAOTE S.P. A model: MylabX75 with linear probe of frequency between 4-15MHz.The patients will be placed in the supine position, with their eyes closed and head in the neutral position elevated to 30 degrees. The transducer will be gently placed on the temporal region of the upper eyelid and slightly tilted caudally and medially until an image of the orbit was obtained on the axial axis, showing the entry point of the optic nerve into the ocular globe. The image will be taken until cross-sectional measurement of the optic nerve sheath 3 mm from its entry into the ocular globe. The procedure will be performed three times on each eye, with the final value recorded in millimeters corresponding to the mean of all the measurements. All women will be followed till delivery and pregnancy outcome will be recorded as defined above.
OUTCOMES:
-
Correlation of pregnancy outcome in preeclampsia with optic nerve sheath diameter.
-
Sensitivity, specificity, predictive value and cut-off of optic nerve sheath diameter for predicting adverse pregnancy outcomes in preeclampsia.
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
- •Antenatal women with POG more than 28 weeks with preeclampsia.
排除标准
- •Known neurological disorders (eg epilepsy, intracranial space-occupying lesion, trauma, hydrocephalus)
- •Ocular disease affecting optic nerve (optic neuritis, orbital cellulitis, glaucoma)
- •Chronic renal disease / chronic liver disease not related to pre-eclampsia
- •Long-term Magnesium therapy or diuretics
- •Multiple pregnancy
- •Fetal anomalies.
结局指标
主要结局
Correlation of pregnancy outcome in preeclampsia with optic nerve sheath diameter
时间窗: baseline,24 hours
diameter.
时间窗: baseline,24 hours
次要结局
- Sensitivity, specificity, predictive value & cut-off of Optic Nerve Sheath diameter for predicting adverse pregnancy outcomes in preeclampsia.
研究者
Dr Divya Pandey
VMMC and Safdarjung Hospital
