Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations

NCT ID: NCT06371781

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-07-01

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Serum Netrin-4, Resistin and Sfrp-5 level measurement

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.

Group Type: EXPERIMENTAL

Serum Netrin-4, Resistin and Sfrp-5 level measurement

Intervention Type: DIAGNOSTIC_TEST

Measurements of the levels of these molecules in the serum samples of the study group will be done with the ELISA kit.

diagnosis of the study group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

ilkin seda can caglayan

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İlkin Seda CAN ÇAĞLAYAN, Asso.Prof.

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Sivas Cumhuriyet University

Sivas, Centre, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1919B012108892

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Cumhuriyetobgyn

Identifier Type: -

Identifier Source: org_study_id