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

Bozok University

Status: Completed

Conditions: Mask; Covid-19; Pregnant; Fetus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05578729

YOBU_YETERŞENER_131822

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

91 participants in 3 patient groups

Single surgical mask group

Other group

Description:

Participants wore single surgical masks.

Treatment:

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

Double surgical mask group

Other group

Description:

Participants wore double surgical masks.

Treatment:

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

N95 mask group

Other group

Description:

Participants wore N95 masks.

Treatment:

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