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

Not Applicable

Completed

• Conditions: Pregnant; Covid-19; Fetus; Mask
• Interventions: Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group

• Registration Number: NCT05578729
• Lead Sponsor: Bozok University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N95 mask group	Single surgical mask group, Double surgical mask group, N95 mask group	Participants wore N95 masks.
Double surgical mask group	Single surgical mask group, Double surgical mask group, N95 mask group	Participants wore double surgical masks.
Single surgical mask group	Single surgical mask group, Double surgical mask group, N95 mask group	Participants wore single surgical masks.

Primary Outcome Measures

Name	Time	Method
Vital signs	30 minutes later, just before the NST was performed.	Pulse (Pulse was measured in beats per minute/bpm)
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 Outcome Measures

Name	Time	Method
Vital signs	Just after the NST was finished (after 20 minutes)	Pulse (Pulse was measured in beats per minute/bpm)

Trial Locations

Locations (1)

Yeter; 🇹🇷 Yozgat, Turkey