Pre-hypertension in late pregnancy in mothers with sleep deprivation Pregnancy and Childbirth
Conditions
Interventions
This is an interventional randomized controlled study in which participants will be assigned by a computer (only revealed after the opening of an envelope after mothers consent to participate) into tw
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Blood pressure within suboptimal/pre-hypertension range (systolic 120-139 and/or diastolic 80-89 mmHg) 2. Self-reported sleep of less than 6 hours 3. Gestation 34-36 weeks 4. Age more or equal to 18 years old 5. Singleton pregnancy
Exclusion criteria
Exclusion criteria: 1. Anticipated delivery in the next week 2. Significant visual and/or hearing impairment 3. On antihypertensives for gestational hypertension or chronic hypertension 4. Known sleep disorders: Chronic insomnia, sleep apnoea 5. Known psychiatric disorders: Depression, schizophrenia etc. 6. Known major medical disorders: Diabetic Mellitus type 1 or 2, SLE, thyroid disorders, epilepsy, heart diseases etc. 7. Inability/unwillingness to use an eye mask and earplugs 8. Inability/unwillingness to use ActiGraph wGT3X-BT device 9. BMI >35 10. Active smoker 11. Current alcohol consumption 12. Multipara with co-sleeping child/children 13. Night shift workers 14. Night caretaker of other family members 15. Gross fetal anomalies 16. Intrauterine fetal death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Systolic blood pressure measured using an automated blood pressure machine from recruitment to during the intervention period 2. Diastolic blood pressure measured using an automated blood pressure machine from recruitment to during the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcome: 1. Mean arterial pressure measured using an automated blood pressure machine from recruitment to during the intervention period 2. Pregnancy-induced hypertension (systolic BP = 140 and/or diastolic = 90 mmHg) on 2 occasions at least 4 hours measured using an automated blood pressure machine apart during the intervention period 3. Actigraphy derived-night sleep duration measured using data recorded in the watch app during the intervention period 4. Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at recruitment and at the end of the intervention period 5. Pregnancy outcome measured using data recorded in patient medical notes: 5.1. Labour induction 5.2. Mode of delivery 5.3. Peri-delivery blood loss Neonatal outcome measured using data recorded in patient medical notes after birth: 1. Birth weight 2. Cord arterial blood pH and base excess 3. Health evaluation measured using APGAR scoring at 1 and 5 minutes after birth 4. Neonatal intensive care unit (NICU) admission | — |
Countries
Malaysia
Outcome results
None listed