Correlation of single deepest vertical pocket of amniotic fluid and amniotic fluid index at term with foetal outcome
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postpartum admission to neonatal intensive care unit
研究概览
简要总结
Amniotic fluid assessment plays a crucial role in managing pregnancy, with various techniques available to evaluate amniotic fluid volume. Among these techniques, the single deepest vertical pocket (SDVP) measurement and amniotic fluid index (AFI) are commonly used in clinical practice. However, there is limited evidence comparing the predictive value of these two methods for fetal outcomes in term pregnancies. This study aims to compare SDVP measurement with AFI in term pregnancy and assess their correlation with fetal outcomes, particularly the need for neonatal intensive care unit (NICU) admission.
Material and Methods: This randomized controlled trial will be conducted at the Department of Obstetrics & Gynecology, AVBRH, DMIHER, over two years. 150-term pregnant women will be enrolled and randomly allocated to the SDVP or the AFI measurement group. Demographic data, obstetric history, and baseline characteristics will be collected at enrollment. Based on their allocated group, participants will undergo ultrasound examinations to measure SDVP or AFI. Followup will occur throughout pregnancy, labor, and postpartum, with neonatal outcomes assessed, including Apgar scores and NICU admission. Statistical analysis will involve descriptive statistics, inferential statistics, and multivariable regression analysis to assess the association between the allocated intervention and fetal outcomes.
Expected Outcome: We anticipate the study will provide valuable insights into the comparative effectiveness of SDVP measurement and AFI in predicting fetal outcomes in term pregnancies. We hypothesize that SDVP measurement may offer comparable or superior predictive value compared to AFI for identifying pregnancies at increased risk of adverse fetal outcomes, such as NICU admission. The findings of this study may have implications for clinical practice by informing obstetricians and healthcare providers about the optimal method for amniotic fluid assessment in term pregnancies, ultimately improving perinatal care and neonatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •At term pregnant women with gestational age of 37 to 40 weeks with amniotic fluid assessment done in last 7 days
- •Singleton pregnancy with cephalic presentation
- •Confirmed period of gestation by an ultrasound scan performed in first trimester of pregnancy Â
- •Intact membranes without rupture on admission to labour room
- •Those patients who are willing to get enrolled in the study.
排除标准
- •Patients with previous Cesarean section.
- •History of gestational hypertension and/or diabetes mellitus, multiple gestation, premature rupture of the membranes, placenta previa or any other placental anomaly, polyhydramnios, bad obstetrical history, antepartum haemorrhage
- •Structural or chromosomal foetal malformation, intrauterine growth restriction, intrauterine foetal death, RH incompatibility.
结局指标
主要结局
Postpartum admission to neonatal intensive care unit
时间窗: Admission will be done at the time of admission. The study will be carried for a period of 2 years.
次要结局
- 1. Apgar score at birth and at 5 minutes(2. Incidence of oligohydramnios)
研究者
Shefali Singh
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha