Obesity, MaternalNCT06540014
The Difference of Weight Gain Tendencies and Obesity During Pregnancy
An observational study of Obesity, Maternal and Weight Gain, Maternal, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Maternal, Weight Gain, Maternal, Birth Weight
- How many people
- 323 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Jun 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Significant deficiencies in medical records
- Belonging to an ethnic group other than Turkish or Syrian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Difference of Weight Gain Tendencies During Pregnancy According to Pregestational Body Mass Indices of the Mothers in Two Different Ethnic Populations- Does it Make Difference Regarding Neonatal Outcomes?
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.
Read the detailed description
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.
- Being tested
- No intervention
- Keywords
- Maternal obesity, neonatal outcome, weight gain in pregnancy, immigrant, Syrian, Turkish
- Medical subject headings
- Pregnancy in Obesity, Gestational Weight Gain, Birth Weight, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is made, groups are formed just due to the races.
| Study group | Role | What they receive |
|---|---|---|
| Turkish | Belonging to Turkish race originally Receives: Other: No intervention | |
| Syrian | Belonging to Syrian race originally Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight gain
Total body weight gained by pregnant women during pregnancy according to the measurements made by "Tanita" scale
Measured: 1 year period until inclusion
Secondary outcomes (1)
Obesity and overweight
Pregestational obesity or being overweight
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2022
- Primary completion28 Feb 2023
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, MaternalStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Suzan Şahin, Assoc.Prof., Study director, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540014
- Sponsor's protocol ID
- BucaSeyfiDemirsoyRTH
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27590385Zhao 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.
PubMed 28716548Heslehurst 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.
PubMed 17305899
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Weight Gain Tendencies During Pregnancy According to Pregestational Body Mass Indices of the Mothers in Two Different Ethnic Populations- Does it Make Difference Regarding Neonatal Outcomes?
- ClinicalTrials.gov ID
- NCT06540014
- Acronym / sponsor ID
- BucaSeyfiDemirsoyRTH
- Keywords
- Maternal obesity, neonatal outcome, weight gain in pregnancy, immigrant, Syrian, Turkish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 6 Aug 2024 (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: 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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turkish | – | Other: No interventionBelonging to Turkish race originally |
| Syrian | – | Other: No interventionBelonging to Syrian race originally |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Significant deficiencies in medical records
- Belonging to an ethnic group other than Turkish or Syrian
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 |
|---|---|---|
| No interventionNo intervention is made, groups are formed just due to the races. | Other | Syrian, Turkish |
Primary outcome
Maternal weight gain
Time frame: 1 year period until inclusion
Total body weight gained by pregnant women during pregnancy according to the measurements made by "Tanita" scale
1 secondary outcome
Obesity and overweight
Time frame: 6 months
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 6 Aug 2024.
- Results publication: PubMed 27590385Hung 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.
- Results publication: PubMed 28716548Zhao 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.
- Results publication: PubMed 17305899Heslehurst 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.
- 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.
Suzan Şahin, Assoc.Prof. study director
Izmir Democracy University
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 Obesity, Maternal and Weight Gain, Maternal, run by Zekai Tahir Burak Women's Health Research and Education Hospital 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 2 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 6 Aug 2024. 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?
Maternal weight gain (time frame: 1 year period until inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540014, which also lists 3 linked publications.
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 6 Aug 2024.