CClinicalTrials.gg
CompletedNCT06371781Updated Apr 22, 2024

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

An interventional study of Serum Netrin-4, Resistin and Sfrp-5 level measurement in Excessive Weight Gain During Pregnancy, sponsored by Cumhuriyet University. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Cumhuriyet University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jul 2022, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Excessive Weight Gain During Pregnancy

Keywords

  • Sfrp-5
  • Netrin-4
  • Resistin
  • gestational weight gain
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 90 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Cumhuriyet University is the lead sponsor of 128 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • singleton pregnant women over 37 weeks
  • Without metabolic disorders
  • Do not use medication
  • Healthy fetuses and mom

Exclusion criteria

Exclusion Criteria:

  • pregestational diabetes,
  • gestational diabetes
  • hypertension and related metabolic diseases
  • twin pregnancies,
  • pregnancies under 37 weeks
  • with large babies
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    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.

    Diagnostic Test: Serum Netrin-4, Resistin and Sfrp-5 level measurement

  • No intervention
    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.

Interventions

  • Diagnostic testSerum 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: one day

07

Study locations

1 site
  • Sivas Cumhuriyet University
    Sivas, Centre 58140, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06371781
Lead sponsor
Cumhuriyet University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
ilkin seda can caglayan (assistant professor, Cumhuriyet University) — Principal investigator
First posted
Apr 17, 2024
Start date
Jul 1, 2022
Primary completion
Jul 1, 2022
Completion
Jul 1, 2023
Last update
Apr 22, 2024

Study contacts

İlkin Seda CAN ÇAĞLAYAN, Asso.Prof.
study director · Cumhuriyet University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion