NCT06371781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

April 4, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Sfrp-5Netrin-4Resistingestational weight gain

Outcome Measures

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.

    one day

Secondary Outcomes (1)

  • Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis.

    one day

Study Arms (2)

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.

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.

Interventions

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

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

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Centre, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • İlkin Seda CAN ÇAĞLAYAN, Asso.Prof.

    Cumhuriyet University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 17, 2024

Study Start

July 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations