Covid-19NCT05578729
The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
A study testing Single surgical mask group, Double surgical mask group, N95 mask group in people with Covid-19 and Pregnant, run by Bozok University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- Single surgical mask group, Double surgical mask group, N95 mask group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 19 years or older
- Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy
- Being followed on an outpatient basis
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Single surgical mask group, Double surgical mask group, N95 mask group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single surgical mask group, Double surgical mask group, N95 mask groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single surgical mask group | Other | Participants wore single surgical masks. Receives: Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group |
| Double surgical mask group | Other | Participants wore double surgical masks. Receives: Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group |
| N95 mask group | Other | Participants wore N95 masks. Receives: Behavioral: Single surgical mask group, Double surgical mask group, N95 mask group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Measured: 30 minutes later, just before the NST was performed.
Vital signs
Respiratory rate (Respiratory rate per minute was measured)
Measured: 30 minutes later, just before the NST was performed.
Vital signs
SpO2 saturation (SpO2 saturation was measured in %)
Measured: 30 minutes later, just before the NST was performed.
Vital signs
Pulse (Pulse was measured in beats per minute/bpm)
Measured: 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.
Measured: Just after the NST was finished (after 20 minutes)
Secondary outcomes (4)
Vital signs
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Measured: Just after the NST was finished (after 20 minutes)
Vital signs
Respiratory rate (Respiratory rate per minute was measured)
Measured: Just after the NST was finished (after 20 minutes)
Vital signs
SpO2 saturation (SpO2 saturation was measured in %)
Measured: Just after the NST was finished (after 20 minutes)
Vital signs
Pulse (Pulse was measured in beats per minute/bpm)
Measured: Just after the NST was finished (after 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeter ŞENER, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578729
- Sponsor's protocol ID
- YOBU_YETERŞENER_131822
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I WILL SEND THE JOURNAL AFTER I REGISTER HERE.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
- ClinicalTrials.gov ID
- NCT05578729
- Acronym / sponsor ID
- YOBU_YETERŞENER_131822
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
| Arm | Type | Receives |
|---|---|---|
| Single surgical mask group | Other | Behavioral: Single surgical mask group, Double surgical mask group, N95 mask groupParticipants wore single surgical masks. |
| Double surgical mask group | Other | Behavioral: Single surgical mask group, Double surgical mask group, N95 mask groupParticipants wore double surgical masks. |
| N95 mask group | Other | Behavioral: Single surgical mask group, Double surgical mask group, N95 mask groupParticipants wore N95 masks. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being 19 years or older
- Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy
- Being followed on an outpatient basis
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single surgical mask group, Double surgical mask group, N95 mask groupMasks 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. | Behavioural | Double surgical mask group, N95 mask group, Single surgical mask group |
Primary outcome
Vital signs
Time frame: 30 minutes later, just before the NST was performed.
Blood pressure-Systolic and diastolic (Blood pressure measured in mmHg)
Vital signs
Time frame: 30 minutes later, just before the NST was performed.
Respiratory rate (Respiratory rate per minute was measured)
Vital signs
Time frame: 30 minutes later, just before the NST was performed.
SpO2 saturation (SpO2 saturation was measured in %)
Vital signs
Time frame: 30 minutes later, just before the NST was performed.
Pulse (Pulse was measured in beats per minute/bpm)
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.
4 secondary outcomes
Vital signs
Time frame: Just after the NST was finished (after 20 minutes)
Vital signs
Time frame: Just after the NST was finished (after 20 minutes)
Vital signs
Time frame: Just after the NST was finished (after 20 minutes)
Vital signs
Time frame: Just after the NST was finished (after 20 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided. I WILL SEND THE JOURNAL AFTER I REGISTER HERE.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single surgical mask group, Double surgical mask group, N95 mask group in people with Covid-19 and Pregnant, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital signs (time frame: 30 minutes later, just before the NST was performed.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.