NCT06540014

Brief Summary

Background: Excess weight and obesity are a global pandemic, particularly among women of childbearing age. Pre-pregnancy obesity is linked to adverse maternal and neonatal outcomes, including preterm birth, macrosomia, stillbirth, and neonatal death. These risks vary by maternal age, race, and ethnicity, with rising rates among immigrant and minority women. This study investigates overweight and obesity rates in pregnant women, weight gain during pregnancy, and adherence to guidelines and possible neonatal outcomes, comparing Turkish and Syrian immigrant women. Methods: This retrospective single-center study was conducted at Buca Seyfi Demirsoy Teaching and Research Hospital in Izmir, Turkey, over one year. Data collected included demographic information, pregnancy complications, delivery modes, maternal and neonatal anthropometric measurements, and neonatal morbidity and mortality. The study included Turkish and Syrian women with complete medical records. Statistical analyses were performed using SPSS software, with significance set at p \< 0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

July 27, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

Maternal obesityneonatal outcomeweight gain in pregnancyimmigrantSyrianTurkish

Outcome Measures

Primary Outcomes (1)

  • Maternal weight gain

    Total body weight gained by pregnant women during pregnancy according to the measurements made by "Tanita" scale

    1 year period until inclusion

Secondary Outcomes (1)

  • Obesity and overweight

    6 months

Other Outcomes (2)

  • Neonatal morbidities

    6 months

  • Adherence to the weight gain guidelines

    6 months

Study Arms (2)

Turkish

Belonging to Turkish race originally

Other: No intervention

Syrian

Belonging to Syrian race originally

Other: No intervention

Interventions

No intervention is made, groups are formed just due to the races.

SyrianTurkish

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In the study, the hospital records of all pregnant women admitted for delivery at the obstetrics ward of the Women's and Children's Diseases additional service building Buca Seyfi Demirsoy Training and Research Hospital were retrospectively reviewed over a 6-month period from September 1, 2022, to February 28, 2023.

You may qualify if:

  • Being admitted to our hospital for delivery or having just given birth
  • Being Turkish or Syrian
  • Having all detailed information, including mothers' pregestational and immediate pre-delivery body weights, available in medical records

You may not qualify if:

  • Significant deficiencies in medical records
  • Belonging to an ethnic group other than Turkish or Syrian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buca Seyfi Demirsoy RTH

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

  • Hung TH, Hsieh TT. Pregestational body mass index, gestational weight gain, and risks for adverse pregnancy outcomes among Taiwanese women: A retrospective cohort study. Taiwan J Obstet Gynecol. 2016 Aug;55(4):575-81. doi: 10.1016/j.tjog.2016.06.016.

  • Zhao R, Xu L, Wu ML, Huang SH, Cao XJ. Maternal pre-pregnancy body mass index, gestational weight gain influence birth weight. Women Birth. 2018 Feb;31(1):e20-e25. doi: 10.1016/j.wombi.2017.06.003. Epub 2017 Jul 14.

  • Heslehurst N, Ells LJ, Simpson H, Batterham A, Wilkinson J, Summerbell CD. Trends in maternal obesity incidence rates, demographic predictors, and health inequalities in 36,821 women over a 15-year period. BJOG. 2007 Feb;114(2):187-94. doi: 10.1111/j.1471-0528.2006.01180.x.

MeSH Terms

Conditions

Pregnancy in ObesityGestational Weight GainBirth WeightPregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight Changes

Study Officials

  • Suzan Şahin, Assoc.Prof.

    Izmir Democracy University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 27, 2024

First Posted

August 6, 2024

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

June 15, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations