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Completed

NCT Number: NCT05578729

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Fetus Infections Lung Diseases Mask Nidovirales Infections Pneumonia Pneumonia, Viral Pregnant RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yeter

Yozgat, 66000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Vital signs

    Time frame: 30 minutes later, just before the NST was performed.

    Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)

  2. Vital signs

    Time frame: 30 minutes later, just before the NST was performed.

    Respiratory rate (Respiratory rate per minute was measured)

  3. Vital signs

    Time frame: 30 minutes later, just before the NST was performed.

    SpO2 saturation (SpO2 saturation was measured in %)

  4. Vital signs

    Time frame: 30 minutes later, just before the NST was performed.

    Pulse (Pulse was measured in beats per minute/bpm)

  5. Non stress test

    Time frame: 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 outcomes

  1. Vital signs

    Time frame: Just after the NST was finished (after 20 minutes)

    Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)

  2. Vital signs

    Time frame: Just after the NST was finished (after 20 minutes)

    Respiratory rate (Respiratory rate per minute was measured)

  3. Vital signs

    Time frame: Just after the NST was finished (after 20 minutes)

    SpO2 saturation (SpO2 saturation was measured in %)

  4. Vital signs

    Time frame: Just after the NST was finished (after 20 minutes)

    Pulse (Pulse was measured in beats per minute/bpm)

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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