Outcome of "Patient Empowerment" in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 459
- 试验地点
- 6
- 主要终点
- Number of Participants with adverse maternal pregnancy outcome
研究概览
简要总结
This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person.
详细描述
Procedure of Study (Including methods of intervention, measurement, estimation etc.):
Screen positive GDM patients will be recruited according to inclusion and exclusion criteria. After taking consent they will be registered for study purpose. According to computer generated randomization the health centres will be allocated and single method of management either patient empowerment or conventional method will be adopted for the whole cluster of the respective health centre. The intervention group will only receive the "Patient Empowerment' package.
The patients of intervention group, along with antenatal check-up, will go through the first session of the empowerment package on the first day of recruitment. Then they will be evaluated through structured questions to know their level of perception/ understanding and retention about the diabetes and its management. Those who will perform to get at least 80% out of 100 will be recognized as empowered. Who fail to achieve that they will be called for next seating. Patients unwilling to go through the process or failed to achieve the targeted score within three seating will be excluded. Those who fulfilled the target, they will be advised to follow the calorie and diet distribution schedule. They will be advised to return back 2 days later, with the blood sugar chart (6 times per day) by SMBG (Self-monitoring of blood glucose). The respondents will get the materials like measuring cup, hand manuals on diabetes, glucometer and chart for record keeping.
After evaluating the sugar chart, if they are found poor performer they will be counselled and trained further and will have to come back again after two days. At the same time patient's satisfaction will be assessed with LIKERT scale. Frequency of further visit will depend on patient's performance.
All the respondents from both groups are supposed to come for ANC at least at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery; frequency of the visit may be more if necessary. For Conventional (non- intervention) group at least 2 to 3 times blood sugar level should be checked within the follow up period. Then all the pertinent variables will be recorded, analyzed as per study objective and outcome, to evaluate the effectiveness of patient empowerment in the management of GDM.
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
At the end of the study, the outcome will be assessed by blinded.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Screen positive GDM cases, who have not been managed for diabetes by any means
- •Gestational age from18 weeks to 36 weeks
排除标准
- •Known history of diabetes before pregnancy
- •Women with twin or multiple pregnancies
结局指标
主要结局
Number of Participants with adverse maternal pregnancy outcome
时间窗: Monthly from enrolment day up to 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation up to delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery
Maternal pregnancy outcome are antenatal infection, Preeclampsia, polyhydramnios, Ante and post partum Haemorrhage, Puerperal sepsis. Maternal death.
Number of Participants with adverse foetal outcome
时间窗: During delivery, After delivery- within 24 hours
Adverse foetal outcome include prematurity, Birth injury, Birth asphyxia, Perinatal death, NICU admission macrosomia (≥ 4 kg) at term, hypoglycaemia (≤ 2.5 mmol/l)
Number of Participants with adequate glycaemic control
时间窗: Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery
Adequate glycaemic control include (a) 80% of blood glucose reading of the month with in normal range. (b) No requirement of insulin or pharmacological agents to manage GDM,
Number of Participants with adverse maternal pregnancy outcome
时间窗: Monthly from enrolment day up to 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation up to delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery
Maternal pregnancy outcome are antenatal infection, Preeclampsia, polyhydramnios, Ante and post partum Haemorrhage, Puerperal sepsis. Maternal death.
Number of Participants with adverse foetal outcome
时间窗: During delivery, After delivery- within 24 hours
Adverse foetal outcome include prematurity, Birth injury, Birth asphyxia, Perinatal death, NICU admission macrosomia (≥ 4 kg) at term, hypoglycaemia (≤ 2.5 mmol/l)
Number of Participants with adequate glycaemic control
时间窗: Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery
Adequate glycaemic control include (a) 80% of blood glucose reading of the month with in normal range. (b) No requirement of insulin or pharmacological agents to manage GDM,
次要结局
- Maternal satisfaction(Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery)
研究者
Tabassum Parveen
Member
Public Health Foundation of Bangladesh