Effects of Antenatal Exercises on Clinical Outcomes in Pregnant Females With Gestational Diabetes Mellitus: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Glucose level
研究概览
简要总结
Gestational diabetes mellitus (GDM) GDM is the most common complication that affects the health of the child and mother during pregnancy. Objectives was to determine the effects of Antenatal exercises on glucose levels, mode of delivery and APGAR Score in females with gestational diabetes mellitus.
This Randomized controlled trial study was conducted on N= 72 pregnant females at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore after Ethical approval of synopsis from institutional Review Board of the University of Lahore . The data was entered and analyzed using SPSS Version 24. .
详细描述
Gestational diabetes mellitus (GDM) is defined as glucose intolerance resulting in hyperglycemia of variable severity with onset during pregnancy. During pregnancy, GDM is the most common complication occurs and it affects the health of the child and mother.
This study aim was to investigate the effect of antenatal exercise on clinical outcomes in pregnant females with gestational diabetes mellitus.
Study Design: Randomized controlled trial. Settings: It was conducted at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore.
Sample Size:
The calculated sample size is 30 in each group using APGAR scale as outcome measure. After adding 20% drop out the sample size will become 30+6 = 36 in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcomes accessor donot know the type of intervention given to patient not during evaluation or data record
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Panel patients who are covered under medical facility provided by the company
- •Booked cases
- •Participant's Borg scale score 6 to 14
- •Age 20-35 years
- •20-24 weeks of gestation
- •Diagnosed case of GDM
- •Primigravida
- •BMI does not exceed 40 kg/m²
排除标准
- •Females diagnosed with vascular complications (Preeclampsia, hemolysis etc.)
- •Uncontrolled diabetes mellitus
- •Autonomic dysfunction /Peripheral neuropathy (Damage to the nerves outside of the brain and spinal cord which effect sensations)
- •Nephropathy or retinopathy (Damage to the small blood vessels of kidneys and eyes)
- •Twins fetus
- •Placenta Previa (placenta partially or totally covers the mother's cervix)
- •Fetal anomalies
- •Female choice for caesarean section
- •Intrauterine growth retardation (fetal complication)
- •Short cervix length
- •Antepartum hemorrhage (bleeding from the genital tract)
结局指标
主要结局
Glucose level
时间窗: 4 months
Effect of antenatal exercise on glucose level was measured by test beta HbAc1 performed by gynecology department before delivery
mode of delivery
时间窗: 4 months
effect of antenatal exercise on type of delivery was studied as it was normal vaginal or caesarian section
APGAR Score
时间窗: 4 months
effect of antenatal exercise on APGAR score was studied which describe fetal health after delivery
次要结局
未报告次要终点