Development and Validation of phone-based App, SwasthGarbh, for improving antenatal care (ameliorating maternal and fetal health)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- 2.Adherence to iron/folate supplementation as evidenced by hemoglobin levels of women.
研究概览
简要总结
Antenatal care (ANC) is must for preventing complications during pregnancy and to ensure healthy mother/child. We will develop a multi-functional smartphone application ‘SwasthGarbh’ (Healthy Pregnancy) for the assistance of pregnant women regarding all the ANC visits and to keep a record of every clinical test/parameter as well as get reminders for the next/missed ANC visit or medication. It will provide a detailed graphic visualization of the systolic/diastolic BP and weight for an easy overview of all the data. Most importantly, both the woman and doctor will get automatic notification if any parameter(s) crosses normal range or any danger sign is present so that timely medical assistance can be provided. Women will have the freedom to inform the doctor about any problem/symptom she is facing on an SOS basis. On getting this information along with clinical reports (if any), the doctor will be able to advise as well as prescribe medicines in real-time (through notification/call). Moreover, the embedded feature, ANC Assist, will help doctors to automatically calculate the schedule of all ANC visits of any patient. Furthermore, to provide assistance in case of any emergency, the App will also display a map highlighting all the nearby hospitals that can be reached in a short time. In addition, it would be possible to install the App in any language desired by the user. Both patients as well as doctors will be able to avail the benefits of the App free of cost!
After the development of App, it will be installed in smartphones provided to primary health care workers and doctors to conduct a clinical study for demonstrating the utility of the App (towards improvement in Hb levels, increase in number of antenatal visits and decrease in obstetric/medical complications). SwasthGarbh will be of immense help for maintaining maternal/fetal health as well as for preventing complications during pregnancy (especially for millions of pregnant women who are living in rural areas and/or do not have easy access to doctors). It aims to provide real-time medical assistance in case of any emergency. It will be an interactive platform which will significantly promote prenatal care in every part of the world. This will be the first pregnancy App that will provide instantaneous access to doctor’s advice and is clinically endorsed as well as credible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women, age between 18-40 years
- •Period of gestation upto 16 weeks
- •Women giving consent.
排除标准
- •Multiple pregnancy
- •Women with chronic medical disorders
- •Women not attending ANC at AIIMS.
结局指标
主要结局
2.Adherence to iron/folate supplementation as evidenced by hemoglobin levels of women.
时间窗: patients will be recruited before 16 week and followed in pregnancy at 28 week, 32 week and 37 weeks.
1. Adherence to antenatal visits and increase in total number of AN visits.
时间窗: patients will be recruited before 16 week and followed in pregnancy at 28 week, 32 week and 37 weeks.
次要结局
- 1. Compare the number of contact pregnant woman made with health care provider for any health problem, beyond regular antenatal visits.(2.Maternal response to ease of use and usefulness of the App.)