Gestational ComplicationsNCT07022158
Antenatal Body Shape Index and Pregnancy Complications
An observational study of Gestational Complications and Body Mass Index, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Complications, Body Mass Index, Waist Circumference
- What is being tested?
- 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.
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 170 patients at 6-16th weeks of gestation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University Faculty of Medicine, 14030, Bolu, Turkey
Bolu, 14030
About this study
Official title: 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.
- Conditions
- Gestational Complications, Body Mass Index, Waist Circumference, Gestational Hypertension, Gestational Diabetes Mellitus (GDM), Preeclampsia (PE)
- Being tested
- 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.
- Keywords
- gestational hypertension, gestational diabetes, preeclampsia, body shape index, waist circumference
- Medical subject headings
- Hypertension, Pregnancy-Induced, Diabetes, Gestational, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-16 weeks of gestation
Secondary outcomes (1)
Number of patients developing pregnancy complications
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.
Measured: gestation period and first 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational ComplicationsStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Betul Esmer, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022158
- Sponsor's protocol ID
- AbantIBU-elifbetulesmer-001
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Antenatal Body Shape Index and Pregnancy Complications
- ClinicalTrials.gov ID
- NCT07022158
- Acronym / sponsor ID
- AbantIBU-elifbetulesmer-001
- Conditions
- Gestational Complications, Body Mass Index, Waist Circumference, Gestational Hypertension, Gestational Diabetes Mellitus (GDM), Preeclampsia (PE)
- Keywords
- gestational hypertension, gestational diabetes, preeclampsia, body shape index, waist circumference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 170 patients at 6-16th weeks of gestation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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. | Other | 184 pregnant women who applied to Bolu Abant İzzet Baysal Training and Research Hospital |
Primary outcome
Calculation of body shape index at 6-16 weeks of gestation
Time frame: 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.
1 secondary outcome
Number of patients developing pregnancy complications
Time frame: gestation period and first 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Complications and Body Mass Index, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of body shape index at 6-16 weeks of gestation (time frame: 6-16 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.