- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07022158
- Original Trial
Antenatal Body Shape Index and Pregnancy Complications
Relationship Between Antenatal Body Shape Index and Pregnancy Complications
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bolu, Turkey, 14030
- Abant Izzet Baysal University Faculty of Medicine, 14030, Bolu, Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Calculation of body shape index at 6-16 weeks of gestation
Time Frame: 6-16 weeks of gestation
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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.
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6-16 weeks of gestation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients developing pregnancy complications
Time Frame: gestation period and first 6 weeks postpartum
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Patients whose body shape index was calculated at 6-16 weeks of gestation were evaluated during pregnancy follow-up according to the development of Gestational Diabetes, Gestational Hypertension and Preeclampsia.
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gestation period and first 6 weeks postpartum
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Diabetes, Gestational
- Pre-Eclampsia
- Hypertension, Pregnancy-Induced
- Hypertension
- Pregnancy Complications
Other Study ID Numbers
- AbantIBU-elifbetulesmer-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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