Placental changes in women with Gestational Diabetes Mellitus : A cross sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Radiological Examination of Placenta:
研究概览
简要总结
The data will be collected from obstetric cases of gestational diabetes that will be presenting at RMCH. The study subject will be recruited in the study after approval of study of Institutional Ethics committee, RMCH Bareilly. An Informed written consent will be taken from the study participants. All data regarding patient’s name, age, parity, socio-economic status, address, time, date, place and current obstetric history, past obstetric history, past menstrual history, family history and personal history, medical comorbities, ultrasonographical investigation including placental thickness and cord thickness performed in the 3rd trimester of the pregnancy and any investigations if needed and mode of delivery.
Gross examination including placental weight, cord length, site of cord insertion. Histopathological examination including diameter, area, circumference, central thickness, villous immaturity, fibrinoid degeneration and syncytial knots and sprouts. Neonatal birth weight, APGAR score at 1min and 5min, need for NICU admissions, its indications and outcome.
Objectives:
·To study the various gross and histomorphological placental changes in women with gestational diabetes mellitus.
·To study the radiological placental alterations in mothers with gestational diabetes mellitus considering placental thickness and cord thickness.
·To assess foetal outcome in terms of birth weight, APGAR score and need for NICU admission.
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
- •ALL pregnant women with gestational diabetes mellitus who give consent.
排除标准
- •Pregnant women with Type 1 diabetes mellitus.
- •Pregnant women with genetic or drug induced glucose intolerance.
- •Pregnant women with MODY (Maturity onset diabetes of the youth).
结局指标
主要结局
Radiological Examination of Placenta:
时间窗: At 28 weeks period of gestation, at term and post delivery.
Placental thickness
时间窗: At 28 weeks period of gestation, at term and post delivery.
Cord thickness
时间窗: At 28 weeks period of gestation, at term and post delivery.
Gross Examination of Placenta
时间窗: At 28 weeks period of gestation, at term and post delivery.
Placental weight
时间窗: At 28 weeks period of gestation, at term and post delivery.
Cord length
时间窗: At 28 weeks period of gestation, at term and post delivery.
Cord insertion site
时间窗: At 28 weeks period of gestation, at term and post delivery.
Histopathological Examination of Placenta:
时间窗: At 28 weeks period of gestation, at term and post delivery.
Diameter
时间窗: At 28 weeks period of gestation, at term and post delivery.
Area
时间窗: At 28 weeks period of gestation, at term and post delivery.
Circumference
时间窗: At 28 weeks period of gestation, at term and post delivery.
Central thickness
时间窗: At 28 weeks period of gestation, at term and post delivery.
Villous immaturity
时间窗: At 28 weeks period of gestation, at term and post delivery.
Fibrinoid degeneration
时间窗: At 28 weeks period of gestation, at term and post delivery.
Syncytial knots or Peinatal Outcome:
时间窗: At 28 weeks period of gestation, at term and post delivery.
Fetal weight
时间窗: At 28 weeks period of gestation, at term and post delivery.
APGAR Score 1min/5min
时间窗: At 28 weeks period of gestation, at term and post delivery.
NICU admission
时间窗: At 28 weeks period of gestation, at term and post delivery.
sprouts
时间窗: At 28 weeks period of gestation, at term and post delivery.
次要结局
- Outdoor patient visit followed by duration of stay during delivery.(1 week after delivery.)
研究者
Dr. Nipunika Singh
Rohilkhand Medical College and Hospital , Pilibhit Bypass Road,Bareilly