NCT07022158

Brief Summary

Background/aim: Gestational diabetes (GDM), gestational hypertension (GHT) and preeclampsia are common complications of pregnancy. In this study, it was aimed to determine the relationship between body shape index (ABSI), calculated based on antenatal measurements of the height, weight and waist circumference, and GDM, GHT and preeclampsia. Materials and methods: 170 patients at 6-16th weeks of gestation were prospectively analyzed. Body mass index (BMI) and ABSI were calculated. Patients were analyzed according to the presence of GDM, GHT and preeclampsia at follow-up. Our study is the first in terms of its subject and makes a significant contribution to the literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

May 23, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

gestational hypertensiongestational diabetespreeclampsiabody shape indexwaist circumference

Outcome Measures

Primary Outcomes (1)

  • Calculation of body shape index at 6-16 weeks of gestation

    The study included pregnant women who applied to the Obstetrics and Gynecology outpatient clinic of Bolu Abant İzzet Baysal Training and Research Hospital between September 2023 and March 2024. During the first antenatal examination of the patients at 6-16 weeks of pregnancy, body shape indexes were calculated by measuring height, body weight and waist circumference.

    6-16 weeks of gestation

Secondary Outcomes (1)

  • Number of patients developing pregnancy complications

    gestation period and first 6 weeks postpartum

Study Arms (1)

184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital

Other: The patients participating in the study were between 6 and 16 weeks of pregnancy. Height, body weight, and waist circumference were measured at the first antenatal visit at 2 weeks.

Interventions

170 patients at 6-16th weeks of gestation were prospectively analyzed. Body mass index (BMI) and ABSI were calculated. Patients were analyzed according to the presence of GDM, GHT and preeclampsia at follow-up.

184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

170 patients at 6-16th weeks of gestation

You may qualify if:

  • Having a singleton pregnancy
  • Pregnancy follow-up and birth must have taken place at Bolu Abant İzzet Baysal University Training and Research Hospital.
  • Voluntary informed consent form must be signed to participate in the study.

You may not qualify if:

  • Multiple pregnancies
  • Additional systemic and chronic diseases (chronic hypertension, DM, hepatic diseases such as cholestasis, cardiac diseases, rheumatic diseases, renal diseases…)
  • History of Gestational Diabetes, Gestational Hypertension and Preeclampsia in previous pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University Faculty of Medicine, 14030, Bolu, Turkey

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedDiabetes, GestationalPre-Eclampsia

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Obstetrics and Gynaecology Specialist

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 15, 2025

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations