Role of transvaginal cervical length and amniotic fluid index in the prediction of latency period in preterm premature rupture of membranes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To study the role of transvaginal cervical length and amniotic fluid index in patients with PPROM between 28 weeks to 36+6 weeks in predicting the delivery latency period
研究概览
简要总结
Patients presenting with preterm premature rupture of membranes (PPROM) between 28 weeks to 36+6 weeks of gestation fulfilling the inclusion and exclusion criteria will be enrolled in the study after taking written informed consent. All the women after admission will be subjected to detailed history including demographic information, maternal parameters like parity, maternal age at the time of admission, gestational age at the time of presentation, obstetric history, menstrual history, past history and family history will be documented. Gestational age will be calculated by last menstrual period or early trimester scan. General physical examination, systemic examination and per abdomen examination will be performed which includes assessment of fundal height, lie of the fetus and presentation of the fetus. We will also assess for contractions, abdominal tenderness and localisation of fetal heart using stethoscope. PPROM will be clinically confirmed by performing a sterile per speculum examination under all aseptic condition (presence of amniotic fluid coming out through cervical os will be noted) and using Litmus paper to check the pH of cervicovaginal secretions. Routine investigations will be done at the time of admission in all subjects which includes haemoglobin, total leukocyte count (TLC), differential leukocyte count(DLC), C-reactive protein(CRP), urine routine microscopy , urine culture sensitivity and a high vaginal swab will be taken .A transabdominal ultrasound will be done in all subjects at the time of admission for determining cardiac activity, fetal biometry, estimated fetal weight, placental localization and liquor. For estimation of amniotic fluid index, abdomen is divided into four compartments and each of the deep cord free vertical pockets of liquor is taken and sum up. After emptying the bladder, transvaginal ultrasound will be done to measure cervical length. Transvaginal cervical length (TVCL) measurement will be done by placing the callipers between external and internal cervical os. All the admitted patients will be put on expectant management, which includes administration of antibiotics and corticosteroids. Maternal and fetal monitoring will be done as per protocol which includes monitoring of signs and symptoms of sepsis, pulse rate, temperature, offensive vaginal discharge, uterine tenderness, fetal heart rate monitoring. Total leucocyte count (TLC), differential leucocyte count (DLC) and C-reactive protein(CRP) will be monitored after every 72 hours till delivery and once after delivery also. Serial USG measurement of amniotic fluid index (AFI) will be done after every 72 hours for better fetal outcome. For the purpose of analysis, each parameter will be divided into mainly two groups that is latency ≤ 7 days and > 7 days , amniotic fluid index (AFI) < 5cms and > 5 cms and transvaginal cervical length (TVCL) < 3 cms and > 3 cms. The primary endpoint will be prediction of delivery latency period based on the admission values of transvaginal cervical length (TVCL) and amniotic fluid index (AFI) in cases with preterm premature rupture of membranes. OUTCOME MEASURES : By taking the admission values of transvaginal cervical length and amniotic fluid index into account in patients with preterm premature rupture of membranes between 28 weeks to 36+6 weeks, we will predict the delivery latency period. Following the delivery of the baby, maternal and neonatal outcomes will be studied. Both mother and baby will be followed up till their stay in the hospital.
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
- •A singleton pregnancy of gestational age between 28 weeks to 36+6 weeks with preterm premature rupture of membranes (PPROM) presenting with less than 72 hours of leaking.
排除标准
- •1 Those in active labor 2 Women with chorioamnionitis 3 Multifetal pregnancy 4 Malpresentation 5 Antepartum hemorrhage 6 Cervical cerclage operation 7 Congenital uterine malformation, previous uterine scar 8 Severe fetal growth restriction 9 Patients requiring immediate termination of pregnancy such as severe pre-eclampsia, eclampsia and NYHA grade 3 and 4 cardiac disease.
结局指标
主要结局
To study the role of transvaginal cervical length and amniotic fluid index in patients with PPROM between 28 weeks to 36+6 weeks in predicting the delivery latency period
时间窗: Baseline and after 3-5 days
次要结局
- To study the maternal and neonatal outcomes in patients with PPROM between 28 weeks to 36+6 weeks.(After 3-5 days)
研究者
Dr Prachi Juneja
Government medical college and hospital ,sector 32 ,Chandigarh
