COVID-19NCT05970874
Evaluation of Hand Grip Strength in Pregnant COVID-19 Patients
An observational study of COVID-19 and Pregnancy Related, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was presented as a cross-sectional, single-center, retrospective case series. Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in the study. The relationship between patients' musculoskeletal symptoms and signs and hand grip strength was investigated. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- COVID-19, Pregnancy Related
- What is being tested?
- Hand grip strength measureme
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 May 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant covid 19 patients
Who may be able to join
- Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19
Who cannot join
- Those with orthopedic defects in the dominant hand and wrist and those with hand, wrist and shoulder involvement on the side of the measurement related to rheumatological diseases were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Musculoskeletal Pain in Pregnant Infected With COVID-19, Evaluation of Fatigue and Muscle Grip Strength
It was presented as a cross-sectional, single-center, retrospective case series. Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in the study. The relationship between patients' musculoskeletal symptoms and signs and hand grip strength was investigated.
Read the detailed description
Covid 19 is the disease defined for strains infected with severe acute respiratory syndrome coronavirus 2(Sars-CoV-2). Hand grip strength is a non-invasive, easily applicable, objective parameter. It was presented as a cross-sectional, single-center, retrospective case series. Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in the study. The relationship between patients' musculoskeletal symptoms and signs and hand grip strength was investigated.
- Conditions
- COVID-19, Pregnancy Related
- Being tested
- Hand grip strength measureme
- Keywords
- COVID-19, Musculoskeletal Symptom, Hand Grip Muscle Streng
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip strength measuremeDevice
Hand grip strength (HSG) was measured in kg with the CAMRY Digital Hand Dynamometer (Model No. EH101, CAMRY).
| Study group | Role | What they receive |
|---|---|---|
| pregnant covid 19 patients | pregnant covid 19 patients Receives: Device: Hand grip strength measureme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength assessment
Hand grip strength assessment in pregnancy Covid 19.
Measured: The first 24 hours after admission to the service.
Secondary outcomes (4)
symptoms
Common symptoms of pregnant Covid 19 patients.
Measured: The first 24 hours after admission to the service.
laboratory findings
Common laboratory findings of pregnant Covid 19 patients.
Measured: The first 24 hours after admission to the service.
Vaccine
Vaccine rate of pregnant Covid 19 patients.
Measured: pre-infection period was questioned
Smoking
Smoking rate of pregnant Covid 19 patients.
Measured: pre-infection period was questioned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Dec 2021
- Primary completion1 May 2022
- Study completion30 May 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Toprak, Principal investigator, dr.tprk@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970874
- Sponsor's protocol ID
- 06-2022/10
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Pain in Pregnant Infected With COVID-19, Evaluation of Fatigue and Muscle Grip Strength
- ClinicalTrials.gov ID
- NCT05970874
- Acronym / sponsor ID
- 06-2022/10
- Conditions
- COVID-19, Pregnancy Related
- Keywords
- COVID-19, Musculoskeletal Symptom, Hand Grip Muscle Streng
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 1 Aug 2023 (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.
It was presented as a cross-sectional, single-center, retrospective case series. Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in the study. The relationship between patients' musculoskeletal symptoms and signs and hand grip strength was investigated.
Detailed description
Covid 19 is the disease defined for strains infected with severe acute respiratory syndrome coronavirus 2(Sars-CoV-2). Hand grip strength is a non-invasive, easily applicable, objective parameter. It was presented as a cross-sectional, single-center, retrospective case series. Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19 were included in the study. The relationship between patients' musculoskeletal symptoms and signs and hand grip strength was investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant covid 19 patients | – | Device: Hand grip strength measuremepregnant covid 19 patients |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant covid 19 patients
Key inclusion criteria (1 listed)
- Pregnant women with a positive Polymerase Chain Reaction (PCR) diagnosis of Covid 19
Key exclusion criteria (1 listed)
- Those with orthopedic defects in the dominant hand and wrist and those with hand, wrist and shoulder involvement on the side of the measurement related to rheumatological diseases were excluded from the study.
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 |
|---|---|---|
| Hand grip strength measuremeHand grip strength (HSG) was measured in kg with the CAMRY Digital Hand Dynamometer (Model No. EH101, CAMRY). | Device | pregnant covid 19 patients |
Primary outcome
Hand grip strength assessment
Time frame: The first 24 hours after admission to the service.
Hand grip strength assessment in pregnancy Covid 19.
4 secondary outcomes
symptoms
Time frame: The first 24 hours after admission to the service.
laboratory findings
Time frame: The first 24 hours after admission to the service.
Vaccine
Time frame: pre-infection period was questioned
Smoking
Time frame: pre-infection period was questioned
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 8 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Hatice Toprak principal investigator
dr.tprk@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pregnancy Related, run by Karaman Training and Research Hospital 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 1 inclusion and 1 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 8 Aug 2023. 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?
Hand grip strength assessment (time frame: The first 24 hours after admission to the service.). 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 8 Aug 2023.