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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05578729
• Other study ID #: YOBU_YETERSENER_131822
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19
• Mask
• Pregnant

Intervention

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.

Locations

Country	Name	City	State
Turkey	Yeter	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs	Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)	30 minutes later, just before the NST was performed.
Primary	Vital signs	Respiratory rate (Respiratory rate per minute was measured)	30 minutes later, just before the NST was performed.
Primary	Vital signs	SpO2 saturation (SpO2 saturation was measured in %)	30 minutes later, just before the NST was performed.
Primary	Vital signs	Pulse (Pulse was measured in beats per minute/bpm)	30 minutes later, just before the NST was performed.
Primary	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	Vital signs	Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)	Just after the NST was finished (after 20 minutes)
Secondary	Vital signs	Respiratory rate (Respiratory rate per minute was measured)	Just after the NST was finished (after 20 minutes)
Secondary	Vital signs	SpO2 saturation (SpO2 saturation was measured in %)	Just after the NST was finished (after 20 minutes)
Secondary	Vital signs	Pulse (Pulse was measured in beats per minute/bpm)	Just after the NST was finished (after 20 minutes)