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临床试验/NCT07382869
NCT07382869尚未招募不适用

Impact of Diet and Physical Activity Based Nurse Led Interventions on Maternal Outcome and Neonatal Outcomes in Women With Gestational Diabetes Mellitus (GDM): A Randomized Controlled Trial

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Maternal glycemic control assessed by HbA1c (%)

研究概览

简要总结

Gestational Diabetes Mellitus (GDM) is a growing maternal health concern associated with adverse neonatal outcomes such as macrosomia and shoulder dystocia, often aggravated by poor dietary habits and physical inactivity during pregnancy. This randomized controlled study aims to evaluate the effectiveness of structured nursing interventions focusing on diet and physical activity in improving maternal glycemic control and reducing neonatal complications. A total of 66 pregnant women diagnosed with GDM will be selected through purposive sampling and randomly allocated into intervention and control groups using the lottery method. The intervention group will receive individualized dietary counselling, pregnancy-appropriate physical activity guidance, and regular nursing follow-up, while the control group will continue with routine antenatal care. Maternal outcomes, including fasting blood glucose and HbA1c levels, will be measured at baseline and follow-up visits. Neonatal outcomes such as macrosomia, mode of delivery, and shoulder dystocia will be documented at birth. Data will be collected using structured tools and analysed using SPSS, with independent t-tests and chi-square tests applied. The study anticipates that structured nursing interventions will significantly improve glycaemic control and reduce adverse neonatal outcomes, supporting the integration of evidence-based nursing care into routine GDM management.

详细描述

Gestational Diabetes Mellitus (GDM) is a growing concern in maternal health, often leading to complications like macrosomia and shoulder dystocia that affect neonatal outcomes. Poor dietary habits and sedentary lifestyles during pregnancy further worsen glycemic control in women with GDM. This study aims to evaluate the impact of structured nursing interventions focused on diet and physical activity on maternal blood sugar levels and neonatal outcomes, particularly macrosomia and shoulder dystocia. The research will test the hypothesis that diet and physical activity-based nursing interventions significantly improve glycemic control and reduce the risk of adverse neonatal outcomes compared to routine prenatal care. The main objectives are to assess changes in maternal fasting blood glucose and HbA1c levels and to evaluate the incidence of macrosomia and shoulder dystocia in neonates. This randomized controlled study will be conducted among 66 pregnant women diagnosed with GDM. Participants will be selected using purposive sampling and assigned to either the intervention group or control group using lottery methods. The intervention group will receive personalized nursing support, including diet education, physical activity guidance tailored for pregnancy, and regular follow-up, while the control group will continue with standard antenatal care. Maternal parameters such as fasting blood glucose, and HbA1c levels will be recorded at baseline and during follow-up visits.

Neonatal outcomes, including macrosomia, mode of delivery, and presence of shoulder dystocia, will be documented at delivery. All data will be collected by the researcher using structured data collection tools. Statistical analysis will be performed using SPSS. Descriptive statistics will summarize demographics and baseline data. Independent t-tests will compare glycaemic outcomes; chi-square tests will be used to compare neonatal outcomes. The anticipated outcome is that diet and physical activity-based nursing interventions will lead to improved maternal glycaemic control and significantly reduce neonatal complications. This study may offer evidence supporting the integration of structured nursing care into routine gestational diabetes mellitus management and this also contribute toward the betterment in terms of maternal and neonatal outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged 18-40 years
  • Diagnosed with GDM in the indexed pregnancy
  • Singleton pregnancy. Pregnant women with gravida 02.

排除标准

  • Pre-existing diabetes mellitus (Type 1 or Type 2)
  • Multiple pregnancies (twins, triplets, etc.)
  • Women with history of Pregnancy induced hypertension. (PIH)
  • History of chronic medical conditions (renal disease, cardiac disorders, epilepsy)
  • Psychiatric illness or cognitive impairment that may affect participation

研究组 & 干预措施

Control Arm: Standard Care

No Intervention

Participants in the control group will receive standard care.

Experimental group

Experimental

Experimental group will receive nurse led intervention including diet,arm chair exercise and walk.

干预措施: Arm chair exercise, Walk, Diet plan will be given to experimental group. (Other)

结局指标

主要结局

Maternal glycemic control assessed by HbA1c (%)

时间窗: Baseline (at enrollment: 24-28 weeks gestation) to 36-38 weeks gestation

Change in maternal glycemic control measured by glycated hemoglobin (HbA1c, %) using standardized laboratory blood assays from baseline (at enrollment) to 36-38 weeks of gestation.

Fasting plasma glucose (mg/dL)

时间窗: Baseline (24-28 weeks gestation) to 36-38 weeks gestation

Change in fasting plasma glucose levels (mg/dL) measured using a fasting venous blood sample at baseline and at 36-38 weeks of gestation.

次要结局

  • Mode of delivery(Mode of delivery (vaginal or cesarean section) recorded from hospital obstetric records at the time of childbirth.)
  • Neonatal birth weight (grams)(Neonatal birth weight (grams) measured within the first hour after birth using a calibrated neonatal weighing scale.)
  • Neonatal Apgar score(Apgar score assessed at 1 and 5 minutes after delivery using the standard Apgar scoring system.)
  • Neonatal complications(Incidence of neonatal complications, including shoulder dystocia and neonatal hypoglycemia, assessed through standard clinical examination and review of neonatal medical records within 48 hours after birth.)
  • Secondary Outcome Measure 5(Description: Maternal weight change measured in kilograms (kg) from enrollment to delivery using routine antenatal weight records.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kausar Ghulam Muhammad

MSN Student

University of Health Sciences Lahore

研究点 (1)

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