A single centre prospective observational study aimed at evaluating fetomaternal outcome in meconium stained liquor and identifying maternal factors associated with meconium stained liquor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of neonatal outcome
研究概览
简要总结
All pregnant women admitted to the labour room of the Department of the Obstetrics and Gynaecology at bhaktivedanta hospital, mumbai during the study period will be screened for eligibility. Those found to have meconium stained amniotic fluid , eithe on spontaneous or artificial rupture of membranes will be enrolled after informed written consent. For each participant , relevant maternal details including age, parity, gestational age and obstetric history will be recorded. The consistency of meconium will be noted and classified as thin or thick. Progress of labour, mode of delivery and any intrapartum interventions or complications will be documented. After delivery , the newborn will be assessed for APGAR scores at 1 and 5 minutes, need for resuscitation, development of meconium aspiration syndrome, NICU admissions and development of perinatal mortality. maternal outcomes such as duration of hospital say, post partum hemorrhage, infections and need for ICU care will be rcorded.All data will be systematically entered into structured case record form.
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.Pregnant women at term with spontaneous or induced labour
- •Presence of meconium stained amniotic fluid noted during labour or at rupture of membranes 3.
排除标准
- •Multiple pregnancies
- •Congenital anomalies detected antenatally or at birth
- •Intrauterine fetal demise
- •Women not consenting to participate.
结局指标
主要结局
Incidence of neonatal outcome
时间窗: Patients will be monitored during the process of labour. | They will be monitored at admission in labour- if membranes have ruptured. | if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially. | Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated. | Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge.
1. meconium aspiration syndrome
时间窗: Patients will be monitored during the process of labour. | They will be monitored at admission in labour- if membranes have ruptured. | if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially. | Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated. | Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge.
2. birth asphyxia
时间窗: Patients will be monitored during the process of labour. | They will be monitored at admission in labour- if membranes have ruptured. | if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially. | Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated. | Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge.
3. NICU admissions
时间窗: Patients will be monitored during the process of labour. | They will be monitored at admission in labour- if membranes have ruptured. | if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially. | Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated. | Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge.
4. Neontal mortality
时间窗: Patients will be monitored during the process of labour. | They will be monitored at admission in labour- if membranes have ruptured. | if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially. | Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated. | Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge.
Maternal outcome such as-puerperal complications
时间窗: Patients will be monitored during the process of labour. | They will be monitored at admission in labour- if membranes have ruptured. | if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially. | Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated. | Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge.
次要结局
- Identification of maternal factors associated with MSL(1. Maternal age)
研究者
DR YOGINI PATIL
Bhaktivedanta Hospital and Research Institute