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

NCT05578729 | Completed

• 1 other identifier: YOBU_YETERŞENER_131822
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19; Pregnant; Fetus; Mask

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Vital signs

  Just after the NST was finished (after 20 minutes)

• Vital signs

  Just after the NST was finished (after 20 minutes)

• Vital signs

  Just after the NST was finished (after 20 minutes)

• Vital signs

  Just after the NST was finished (after 20 minutes)

Study Arms (3)

Single surgical mask group

OTHER

Participants wore single surgical masks.

Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group

Double surgical mask group

OTHER

Participants wore double surgical masks.

Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group

N95 mask group

OTHER

Participants wore N95 masks.

Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group

Interventions

Single surgical mask group, Double surgical mask group, N95 mask group BEHAVIORAL

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.

Double surgical mask group; N95 mask group; Single surgical mask group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being 19 years or older
• Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy
• Being followed on an outpatient basis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Yeter

Yozgat, 66000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 13, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

TU (1)