Health in Pregnancy

• Research type

  Research Study

• Full title

  Health in Pregnancy , A pilot study observing the health parameters of pregnant women.

• IRAS ID

  233138

• Contact name

  Christoph Lees

• Contact email

  Christoph.Lees@nhs.net

• Sponsor organisation

  Imperial College Joint Research Compliance Office

• Duration of Study in the UK

  1 years, 5 months, 19 days

• Research summary

  The primary objective of the study is to examine the feasibility of the pregnancy health tool as a home monitoring solution for pregnant women to collect additional data for their healthcare professionals. The secondary objective includes investigation of whether the pregnancy health tool can reassure and reduce anxiety of pregnant women by improving insight into health data. It is envisioned to see a trajectory from similar studies undertaken to observe most changes occur in the first trimester.

  The Pregnancy health tool consists of:
  • Blood pressure monitor (CE-marked)
  • Digital weight scale (CE-marked)
  • Health Watch (CE-marked)which will enable monitoring of physical activity and sleep duration.
  • Mobile application (Philips prototype)
  • Healthcare professional dashboard (Philips prototype)
  - Healthcare online tool- EFM feedback to allow electronic questionaires
  - Laptop to access questionnaires and dashboard remotely
  - Non- invasive cardiovascular studies
  - Lifestyle health questionnaires offered at three intervals over the pregnancy
  - Entry and exit questionnaires in the form of semi-structured interviews

  The study is a feasibility study :

  20 Pregnant women will be given pregnancy health tools to monitor lifestyle activities including physical activity, mental health by completing questionnaires namely Edinburgh Postnatal Depression Scale, International physical activity questionnaire and the Spiel Berger State-Trait Anxiety Inventory/ General anxiety scale.

  There will also be an appointment offered for cardiovascular studies which will completed by non invasive ultrasound to measure carotid and femoral pulse wave velocity and aortic augmentation index.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  18/LO/1101

• Date of REC Opinion

  2 Aug 2018

• REC opinion

  Further Information Favourable Opinion