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

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.

Study Overview

• Status: Completed
• Conditions: Covid-19; Pregnant; Mask; Fetus
• Intervention / Treatment: Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yozgat, Turkey, 66000
    • Yeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single surgical mask group; Participants wore single surgical masks.	Behavioral: Single 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.
Other: Double surgical mask group; Participants wore double surgical masks.	Behavioral: Single 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.
Other: N95 mask group; Participants wore N95 masks.	Behavioral: Single 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Bozok University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: YOBU_YETERŞENER_131822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I WILL SEND THE JOURNAL AFTER I REGISTER HERE.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No