Covid-19, Fetus, Mask, Pregnant
Conditions
Brief summary
This study was conducted to examine the effects of different masks used by pregnant women on vital signs and non stress test (NST) during the COVID-19. This study was conducted as a single-blind randomized controlled trial. Healthy pregnant women aged 19 years and older, who were followed up on an outpatient basis, and who were in the 37-40th week of pregnancy, were included in the study. The study consisted of a single surgical mask group (n=30), double surgical mask group (n=30), and N95 mask group (n=31). Masks were given to the resting pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30 minutes, the vital signs of the pregnant women were measured just before and after the NST, and the images of the NST traces were taken.
Interventions
BEHAVIORALSingle surgical mask group, Double surgical mask group, N95 mask group
Masks were given to the resting pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30 minutes, the vital signs of the pregnant women were measured just before and after the NST, and the images of the NST traces were taken.
Sponsors
Bozok University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Being 19 years or older 2. Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy 3. Being followed on an outpatient basis
Exclusion criteria
1. Having a multiple pregnancy 2. Having a systemic, psychiatric disease or psychological problem (thyroid, heart, schizophrenia, etc.) 3. Being in the category of risky pregnancies (Preeclampsia, gestational diabetes, etc.) 4. Smoking 5. Having alcohol and substance use 6. Never done NST before 7. Having an identified risk factor in the fetus 8. Having barriers to communication 9. Being a foreign national 10. Being in contact with, or having, or suspected of having COVID-19 and previously had COVID-19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | 30 minutes later, just before the NST was performed. | Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg) |
| Non stress test | Just after the NST was finished (after 20 minutes) | After the NST was finished, the images were taken by numbering the traces. A folder was created containing the NST traces that were imaged. After all the research data were collected, the NST tracing results (fetal heart rate (bpm), variability, acceleration, deceleration, contraction, reactivity, and non-reactivity) were evaluated by a Gynecology and Obstetrics physician who did not know which group the participants were in. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs | Just after the NST was finished (after 20 minutes) | Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg) |
Countries
Turkey (Türkiye)
Outcome results
None listed