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

Primary Purpose

Covid-19, Pregnant, Fetus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Single surgical mask group, Double surgical mask group, N95 mask group
Sponsored by
Bozok University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid-19

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Yeter

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Single surgical mask group

Double surgical mask group

N95 mask group

Arm Description

Participants wore single surgical masks.

Participants wore double surgical masks.

Participants wore N95 masks.

Outcomes

Primary Outcome Measures

Vital signs
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Vital signs
Respiratory rate (Respiratory rate per minute was measured)
Vital signs
SpO2 saturation (SpO2 saturation was measured in %)
Vital signs
Pulse (Pulse was measured in beats per minute/bpm)
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.

Secondary Outcome Measures

Vital signs
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Vital signs
Respiratory rate (Respiratory rate per minute was measured)
Vital signs
SpO2 saturation (SpO2 saturation was measured in %)
Vital signs
Pulse (Pulse was measured in beats per minute/bpm)

Full Information

First Posted
October 6, 2022
Last Updated
October 11, 2022
Sponsor
Bozok University
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1. Study Identification

Unique Protocol Identification Number
NCT05578729
Brief Title
The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
Official Title
The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozok University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Pregnant, Fetus, Mask

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single surgical mask group
Arm Type
Other
Arm Description
Participants wore single surgical masks.
Arm Title
Double surgical mask group
Arm Type
Other
Arm Description
Participants wore double surgical masks.
Arm Title
N95 mask group
Arm Type
Other
Arm Description
Participants wore N95 masks.
Intervention Type
Behavioral
Intervention Name(s)
Single surgical mask group, Double surgical mask group, N95 mask group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vital signs
Description
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Time Frame
30 minutes later, just before the NST was performed.
Title
Vital signs
Description
Respiratory rate (Respiratory rate per minute was measured)
Time Frame
30 minutes later, just before the NST was performed.
Title
Vital signs
Description
SpO2 saturation (SpO2 saturation was measured in %)
Time Frame
30 minutes later, just before the NST was performed.
Title
Vital signs
Description
Pulse (Pulse was measured in beats per minute/bpm)
Time Frame
30 minutes later, just before the NST was performed.
Title
Non stress test
Description
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.
Time Frame
Just after the NST was finished (after 20 minutes)
Secondary Outcome Measure Information:
Title
Vital signs
Description
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Time Frame
Just after the NST was finished (after 20 minutes)
Title
Vital signs
Description
Respiratory rate (Respiratory rate per minute was measured)
Time Frame
Just after the NST was finished (after 20 minutes)
Title
Vital signs
Description
SpO2 saturation (SpO2 saturation was measured in %)
Time Frame
Just after the NST was finished (after 20 minutes)
Title
Vital signs
Description
Pulse (Pulse was measured in beats per minute/bpm)
Time Frame
Just after the NST was finished (after 20 minutes)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Yeter
City
Yozgat
ZIP/Postal Code
66000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
I WILL SEND THE JOURNAL AFTER I REGISTER HERE.

Learn more about this trial

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

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