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
Verified date | October 2022 |
Source | Bozok University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Yeter | Yozgat |
Lead Sponsor | Collaborator |
---|---|
Bozok University |
Turkey,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|