The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19

Conditions
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Covid-19, Pregnant, Fetus, Mask

Intervention / Treatment
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* Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 19 years or older Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy Being followed on an outpatient basis Exclusion Criteria: Having a multiple pregnancy Having a systemic, psychiatric disease or psychological problem (thyroid, heart, schizophrenia, etc.) Being in the category of risky pregnancies (Preeclampsia, gestational diabetes, etc.) Smoking Having alcohol and substance use Never done NST before Having an identified risk factor in the fetus Having barriers to communication Being a foreign national Being in contact with, or having, or suspected of having COVID-19 and previously had COVID-19.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single surgical mask group<br>Participants wore single surgical masks. | Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group<br>* 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.<br>|
| Other: Double surgical mask group<br>Participants wore double surgical masks. | Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group<br>* 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.<br>|
| Other: N95 mask group<br>Participants wore N95 masks. | Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg) | 30 minutes later, just before the NST was performed. | 
| Vital signs | Respiratory rate (Respiratory rate per minute was measured) | 30 minutes later, just before the NST was performed. | 
| Vital signs | SpO2 saturation (SpO2 saturation was measured in %) | 30 minutes later, just before the NST was performed. | 
| Vital signs | Pulse (Pulse was measured in beats per minute/bpm) | 30 minutes later, just before the NST was performed. | 
| Non stress test | 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. | Just after the NST was finished (after 20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg) | Just after the NST was finished (after 20 minutes) | 
| Vital signs | Respiratory rate (Respiratory rate per minute was measured) | Just after the NST was finished (after 20 minutes) | 
| Vital signs | SpO2 saturation (SpO2 saturation was measured in %) | Just after the NST was finished (after 20 minutes) | 
| Vital signs | Pulse (Pulse was measured in beats per minute/bpm) | Just after the NST was finished (after 20 minutes) |