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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06371781
Other study ID # Cumhuriyetobgyn
Secondary ID 1919B012108892
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date July 1, 2023

Study information

Verified date April 2024
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 1, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - singleton pregnant women over 37 weeks - Without metabolic disorders - Do not use medication - Healthy fetuses and mom Exclusion Criteria: - pregestational diabetes, - gestational diabetes - hypertension and related metabolic diseases - twin pregnancies, - pregnancies under 37 weeks - with large babies

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Serum Netrin-4, Resistin and Sfrp-5 level measurement
Measurements of the levels of these molecules in the serum samples of the study group will be done with the ELISA kit.

Locations

Country Name City State
Turkey Sivas Cumhuriyet University Sivas Centre

Sponsors (2)

Lead Sponsor Collaborator
Cumhuriyet University Scientific and Technological Research Council of Turkey (TUBITAK)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one day
Secondary 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. one day
See also
  Status Clinical Trial Phase
Completed NCT01782105 - Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation N/A