No registrations found.
ID
Source
Brief title
Health condition
hypertensive disorders of pregnancy (HDP), threatened preterm birth (TPB), preterm premature rupture of membranes (PPROM), vaginal blood loss
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate the effect of routine obstetric medications on maternal PPG features in complicated pregnancies, with specific focus on heart rate variability.
Secondary outcome
Investigate PPG features of women who deliver preterm.
Investigate the PPG features throughout different stages of delivery (compared to CTG data)
Investigate differences in PPG features between normotensive and hypertensive subjects.
Investigate PPG features at 6 weeks postpartum.
Background summary
This is a longitudinal, observational study. Participants will be pregnant women admitted to the maternity wards who will receive routine obstetric medications. The outcomes will be long-term, continuous photoplethysmography (PPG) and corresponding accelerometer data. These data will be acquired with a wrist-worn PPG device, similar to a smart-watch. This device is a CE-marked non-medical device. From these PPG, data features can be derived, for example heart rate (variability). Henceforth these will be referred to as PPG features.
The study will have two phases. In phase 1, data will be gathered during the subject's stay in the maternity ward. An in-patient comparison of the PPG features will be done between the epoch before and after drug administration. Upon discharge, the subjects will be invited to participate in phase 2 of the study, which takes place at 6 weeks postpartum. In phase 2, they will wear the wrist-worn PPG device for a full day. Data from the patients' electronic medical records (gathered as part of standard care) will be used to minimize confounding effects in data analysis and interpret the results.
Participating in this study has no effect on the treatment plan or clinical care of the subjects.
Study objective
Antenatal corticosteroids (a routine obstetric medication) reduces variability in maternal heart rate.
Study design
Niet-WMO ruling received: December 2019. Start of study: January/February 2020. End of study: December 2020.
Inclusion criteria
- Aged 18 years and above
- Gestational age 23 5/7 to 33 6/7 weeks upon admission
- Yet to receive second dose of antenatal corticosteroids
- Proficient in Dutch or English
Exclusion criteria
- History of cardiovascular disease, specifically severe arrhythmia and congenital heart disease
- Cushing’s disease
- Known allergies for hard plastic (like in sport watches) or elastic band material.
- Presence of wounds, injuries or infectious diseases on the skin where the wrist-wearable device will be placed.
- Tattoo on top of wrist (where sensor should be placed)
- No space to place the device (as judged by the health care practitioner placing the device)
- Dexamethasone is given as antenatal corticosteroid instead of Betamethasone
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8204 |
| Other | METC Máxima MC : N19.112 |