Excessive Weight Gain During PregnancyNCT06371781
Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations
A study testing Serum Netrin-4, Resistin and Sfrp-5 level measurement in people with Excessive Weight Gain During Pregnancy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Researchers thought that the molecules Sfrp-5, Resistin and Netrin-4, which will be examine, they may have a significant effect on weight gain during pregnancy. Based on these foundations, researchers expect changes in the levels of these molecules in women who gain excessive weight during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Excessive Weight Gain During Pregnancy
- What is being tested?
- Serum Netrin-4, Resistin and Sfrp-5 level measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jul 2023
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnant women over 37 weeks
- Without metabolic disorders
- Do not use medication
- Healthy fetuses and mom
Who cannot join
- pregestational diabetes,
- gestational diabetes
- hypertension and related metabolic diseases
- twin pregnancies,
- pregnancies under 37 weeks
- with large babies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Centre, 58140
About this study
Official title: Examination of the Relationship Between Sfrp-5, Netrin-4 and Resistin Concentrations in Maternal Blood Samples and Weight Gain During Pregnancy
Researchers thought that the molecules Sfrp-5, Resistin and Netrin-4, which will be examine, they may have a significant effect on weight gain during pregnancy. Based on these foundations, researchers expect changes in the levels of these molecules in women who gain excessive weight during pregnancy. In this study, researchers aimed to examine the moderator relationship between the molecules will be examine and weight gain in women who gained weight above the normal limits determined during pregnancy. For this reason, 44 participant who gained excessive weight during pregnancy and 46 pregnant participant who gained normal weight were included in the study. The levels of Netrin-4, Sfrp-5 and Resistin molecules in the blood serum of the individuals in the study group were measured with a Commercial Elisa kit.
Read the detailed description
In this study, researchers aimed to examine the moderator relationship between molecules such as Netrin-4, Sfrp-5 and Resistin and weight gain in participant with weight gain above the normal limits determined during pregnancy.
Pregnant participants who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital were included in this prospectively designed study. This study was divided into two main groups, the first group will consist of pregnant participant with above-normal weight gain during pregnancy (n = 44), and the other group will consist of pregnant participant with normal weight gain during pregnancy (n = 46). In the study, individuals who agreed to participate in the study were first asked to fill out a form containing demographic data such as age, education, pre- and postnatal height, and weight.
To ensure consistency in women's care, these new Institute of Medicine (IOM) 2009 guidelines are based on BMI cutoffs developed by the World Health Organization and adopted by the National Heart, Lung, and Blood Institute. Weight distribution according to BMI ranges: <18.5 kg/m2 (underweight), 18.5-24.9 kg/m2 (normal weight), 25-29.9 kg/m2 (overweight) and ≥30 kg/m2 (obese). According to these guidelines, the recommended weight gain range for underweight (UW) women is 12.5-18 kg, for normal weight (NW) women 11.5-16 kg and overweight women (OW) 7-11.5 kg, obese ( OB) women are recommended to gain only 5-9 kg during pregnancy. These values according to the IOM-2009 guideline are the most widely accepted recommendations for weight gain during pregnancy. Weight gain above these values researchers have specified will be considered as excessive weight gain for us.The levels of these molecules in the serum of the study groups were measured using a commercial ELISA kit.
- Conditions
- Excessive Weight Gain During Pregnancy
- Being tested
- Serum Netrin-4, Resistin and Sfrp-5 level measurement
- Keywords
- Sfrp-5, Netrin-4, Resistin, gestational weight gain
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Netrin-4, Resistin and Sfrp-5 level measurementDiagnostic test
Measurements of the levels of these molecules in the serum samples of the study group will be done with the ELISA kit.
| Study group | Role | What they receive |
|---|---|---|
| Serum Netrin-4, Resistin and Sfrp-5 level measurement | Experimental | In this study, 5 ml of whole blood will be collected from the study group into a biochemistry tube and centrifuged, and the levels of Netrin-4, Resistin and Sfrp-5 in the separated serum will be measured with an ELISA kit. Receives: Diagnostic Test: Serum Netrin-4, Resistin and Sfrp-5 level measurement |
| diagnosis of the study group | No intervention | Individuals who gained excessive weight during pregnancy will be diagnosed as a patient group by evaluating their pre- and post-pregnancy height, weight and BMI values. Those with normal height, weight and BMI values before and after pregnancy will be included in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin
Blood will be taken from individuals only once; therefore, minor redness and swelling may occur at the site where blood is taken; other than that, there is no serious risk. The measured molecules will be measured in blood serum and there will be no intervention other than blood collection from individuals.Measurements of these three molecules will be measured simultaneously in a single blood sample.
Measured: one day
Secondary outcomes (1)
Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis.
Pre-pregnancy height (m) and weight (kg) measurements of pregnant women participating in the study will be learned and these values will be used to calculate pre-pregnancy BMI. Height (m) and weight (kg) values will be measured as soon as they are included in the study and will be used to calculate pregnancy BMI. There is no risk to individuals.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Weight Gain During PregnancyStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital will be included in our prospectively designed study. Researchers will divide the study into two main groups. The first group will consist of pregnant women with above-normal weight gain during pregnancy, and the other group will consist of pregnant women with normal weight gain during pregnancy. It is estimated that 46 control and 44 pregnant women with overweight will be reached during this period. In the study, first a form containing demographic data such as age, education, height and weight will be filled out.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, ilkin seda can caglayan, Cumhuriyet University
- Investigators
- İlkin Seda CAN ÇAĞLAYAN, Asso.Prof., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371781
- Sponsor's protocol ID
- Cumhuriyetobgyn
- Other IDs
- 1919B012108892
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Sfrp-5, Netrin-4 and Resistin Concentrations in Maternal Blood Samples and Weight Gain During Pregnancy
- ClinicalTrials.gov ID
- NCT06371781
- Acronym / sponsor ID
- Cumhuriyetobgyn
- Conditions
- Excessive Weight Gain During Pregnancy
- Keywords
- Sfrp-5, Netrin-4, Resistin, gestational weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Apr 2024 (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.
Researchers thought that the molecules Sfrp-5, Resistin and Netrin-4, which will be examine, they may have a significant effect on weight gain during pregnancy. Based on these foundations, researchers expect changes in the levels of these molecules in women who gain excessive weight during pregnancy. In this study, researchers aimed to examine the moderator relationship between the molecules will be examine and weight gain in women who gained weight above the normal limits determined during pregnancy. For this reason, 44 participant who gained excessive weight during pregnancy and 46 pregnant participant who gained normal weight were included in the study. The levels of Netrin-4, Sfrp-5 and Resistin molecules in the blood serum of the individuals in the study group were measured with a Commercial Elisa kit.
Detailed description
In this study, researchers aimed to examine the moderator relationship between molecules such as Netrin-4, Sfrp-5 and Resistin and weight gain in participant with weight gain above the normal limits determined during pregnancy.
Pregnant participants who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital were included in this prospectively designed study. This study was divided into two main groups, the first group will consist of pregnant participant with above-normal weight gain during pregnancy (n = 44), and the other group will consist of pregnant participant with normal weight gain during pregnancy (n = 46). In the study, individuals who agreed to participate in the study were first asked to fill out a form containing demographic data such as age, education, pre- and postnatal height, and weight.
To ensure consistency in women's care, these new Institute of Medicine (IOM) 2009 guidelines are based on BMI cutoffs developed by the World Health Organization and adopted by the National Heart, Lung, and Blood Institute. Weight distribution according to BMI ranges: <18.5 kg/m2 (underweight), 18.5-24.9 kg/m2 (normal weight), 25-29.9 kg/m2 (overweight) and ≥30 kg/m2 (obese). According to these guidelines, the recommended weight gain range for underweight (UW) women is 12.5-18 kg, for normal weight (NW) women 11.5-16 kg and overweight women (OW) 7-11.5 kg, obese ( OB) women are recommended to gain only 5-9 kg during pregnancy. These values according to the IOM-2009 guideline are the most widely accepted recommendations for weight gain during pregnancy. Weight gain above these values researchers have specified will be considered as excessive weight gain for us.The levels of these molecules in the serum of the study groups were measured using a commercial ELISA kit.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pregnant women who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital will be included in our prospectively designed study. Researchers will divide the study into two main groups. The first group will consist of pregnant women with above-normal weight gain during pregnancy, and the other group will consist of pregnant women with normal weight gain during pregnancy. It is estimated that 46 control and 44 pregnant women with overweight will be reached during this period. In the study, first a form containing demographic data such as age, education, height and weight will be filled out.
| Arm | Type | Receives |
|---|---|---|
| Serum Netrin-4, Resistin and Sfrp-5 level measurement | Experimental | Diagnostic Test: Serum Netrin-4, Resistin and Sfrp-5 level measurementIn this study, 5 ml of whole blood will be collected from the study group into a biochemistry tube and centrifuged, and the levels of Netrin-4, Resistin and Sfrp-5 in the separated serum will be measured with an ELISA kit. |
| diagnosis of the study group | No intervention | –Individuals who gained excessive weight during pregnancy will be diagnosed as a patient group by evaluating their pre- and post-pregnancy height, weight and BMI values. Those with normal height, weight and BMI values before and after pregnancy will be included in the control group. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnant women over 37 weeks
- Without metabolic disorders
- Do not use medication
- Healthy fetuses and mom
Key exclusion criteria (6 listed)
- pregestational diabetes,
- gestational diabetes
- hypertension and related metabolic diseases
- twin pregnancies,
- pregnancies under 37 weeks
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 |
|---|---|---|
| Serum Netrin-4, Resistin and Sfrp-5 level measurementMeasurements of the levels of these molecules in the serum samples of the study group will be done with the ELISA kit. | Diagnostic test | Serum Netrin-4, Resistin and Sfrp-5 level measurement |
Primary outcome
Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin
Time frame: one day
Blood will be taken from individuals only once; therefore, minor redness and swelling may occur at the site where blood is taken; other than that, there is no serious risk. The measured molecules will be measured in blood serum and there will be no intervention other than blood collection from individuals.Measurements of these three molecules will be measured simultaneously in a single blood sample.
1 secondary outcome
Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis.
Time frame: one day
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 22 Apr 2024.
- Individual participant dataSharing planned: No
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Pregnancy, Obesity
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.
İlkin Seda CAN ÇAĞLAYAN, Asso.Prof. study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Netrin-4, Resistin and Sfrp-5 level measurement in people with Excessive Weight Gain During Pregnancy, run by Cumhuriyet 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 4 inclusion and 6 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 22 Apr 2024. 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?
Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin (time frame: one day). 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 22 Apr 2024.