Clinical trial NCT06371781: Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations
Official title: Examination of the Relationship Between Sfrp-5, Netrin-4 and Resistin Concentrations in Maternal Blood Samples and Weight Gain During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Weight Gain During Pregnancy
Keywords: Sfrp-5
Netrin-4
Resistin
gestational weight gain
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-04-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin
timeFrame: one day
Secondary outcomes:
measure: Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis.
timeFrame: one day
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
state: Centre
Study officials:
affiliation: Cumhuriyet University
name: İlkin Seda CAN ÇAĞLAYAN, Asso.Prof.
role: STUDY_DIRECTOR
References: