ObesityNCT02487641
Obese Pregnant Women: Optimizing Fetal Ultrasound
An observational study of Obesity and Fetal Malformation, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Fetal Malformation
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Mar 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty pregnant women with BMI ≥ 30 Kg/m2, 60 pregnant women with BMI ≥ 35 Kg/m2 and 60 Kg/m2 pregnant women normal weighted (BMI: 18,5-24,9 Kg/m2) will be included. Women will be classified by their pre-pregnancy BMI and all pregnant women with an age ≥ 18 will be offered to attend the project and those who accept will be admitted. The recruitment will be performed at Holbæk Hospital and Odense University Hospital.
Who may be able to join
- Age ≥ 18
- BMI ≥ 30 Kg/m2
- BMI: 18,5-25 Kg/m2
- Understand and speak Danish and thereby be able to give confirmed consent.
Who cannot join
- Multiple gestations
- Overweight (BMI: 25-29,9 Kg/m2)
- Alcohol or drug abuse
- Chronically diseases before pregnancy as diabetes, hypertension, or thyroid diseases
- Gastric bypass or other obesity related surgery
Trial locations and contacts
1 site in 1 country.
Lone Krebs, M.D; DSMc contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynaechology and Obstetrics, Holbaek Hospital
Holbæk, 4300
Ida Thagaard, M.D., +45 59481705, ains@regionsjaelland.dk
Lone Krebs, Dr.Med., +45 59484264, lkrb@regionsjaelland.dk
About this study
Official title: Obese Pregnant Women: Optimizing Mid-trimester Fetal Ultrasound for Risk Estimation During Pregnancy and Childhood
This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.
Read the detailed description
Ultrasound examination for fetal anomaly is especially challenging in obese gravida. The foetus is more likely to have congenital anomalies and imaging in these patients is technically more difficult.
The investigators hypotheses that an earlier ultrasound with alternative technics will improve the quality and thereby improve the identification of anomalies. By using transvaginal ultrasound and abdominal ultrasound at the window just above the symphysis, were the subcutaneous fat is known to be thinner, the investigators hope to achieve a better overview. This will be done by evaluating fetal ultrasound at three different gestational ages (GA); GA 13, 15 and 21 weeks.
- Conditions
- Obesity, Fetal Malformation
- Keywords
- Ultrasound, mid-trimester, Obesity, pregnancy
- Medical subject headings
- Obesity, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderat Obesity | 60 persons with BMI between 30-34.49 kg/m2 | |
| Sever Obesity | 60 persons with BMI above 34.49 kg/m2 | |
| Normal weighted | 60 persons with BMI between 18.5-24.49 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality of ultrasound at 15 compared with 21 weeks of gestation.
Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.
Measured: The participants will be examined for an hour at to different stages of the pregnancy (GA 14+0-15+0, GA 20+0-21+0)
Secondary outcomes (5)
Image quality of ultrasound at 13 compared with 15 weeks of gestation.
Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.
Measured: The participants will be examined for an hour at to different stages of the pregnancy (GA 11+3 - 13+0, GA 14+0-15+0)
Analyses of BMI, visceral to subcutaneous fat ratio, distance from cutis to amnion and hip-waist ratio´s influence on image quality.
Measured: The participants will be examined for an hour at three different stages of the pregnancy (GA 13, GA 15, GA 21 and GA 36 weeks).
Weight estimate
The use of weight estimate in obese pregnant women at GA 36 compared to birthweight.
Measured: The participants will be examined for an hour at GA 36 weeks. The participants will in all be followed until 6 months after birth, which is one year in all.
Amnion fluid in obese
Measurement of amnion fluid by deepest vertical pocket and amnion fluid index.
Measured: The participants will be examined for an hour at three different stages of the pregnancy (GA 15, GA 21, GA 36 weeks)
Crown-rump length (CRL) measurement transvaginal and abdominal
Measurement of CRL in mm, by using two different probes, transvaginal and abdominal.
Measured: The participants will be examined for an hour at GA 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Technical University of Denmark
- Responsible party
- Sponsor
- Investigators
- Ida Näslund Thagaard, M.D., Principal investigator, Department of obstetrics and gynecology, Holbæk Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487641
- Sponsor's protocol ID
- 12-000095
- Status last verified
- Nov 2015
- First submitted
- 23 Jun 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obese Pregnant Women: Optimizing Mid-trimester Fetal Ultrasound for Risk Estimation During Pregnancy and Childhood
- ClinicalTrials.gov ID
- NCT02487641
- Acronym / sponsor ID
- 12-000095
- Conditions
- Obesity, Fetal Malformation
- Keywords
- Ultrasound, mid-trimester, Obesity, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Odense University Hospital, Technical University of Denmark
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- 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.
This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.
Detailed description
Ultrasound examination for fetal anomaly is especially challenging in obese gravida. The foetus is more likely to have congenital anomalies and imaging in these patients is technically more difficult.
The investigators hypotheses that an earlier ultrasound with alternative technics will improve the quality and thereby improve the identification of anomalies. By using transvaginal ultrasound and abdominal ultrasound at the window just above the symphysis, were the subcutaneous fat is known to be thinner, the investigators hope to achieve a better overview. This will be done by evaluating fetal ultrasound at three different gestational ages (GA); GA 13, 15 and 21 weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderat Obesity | – | –60 persons with BMI between 30-34.49 kg/m2 |
| Sever Obesity | – | –60 persons with BMI above 34.49 kg/m2 |
| Normal weighted | – | –60 persons with BMI between 18.5-24.49 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty pregnant women with BMI ≥ 30 Kg/m2, 60 pregnant women with BMI ≥ 35 Kg/m2 and 60 Kg/m2 pregnant women normal weighted (BMI: 18,5-24,9 Kg/m2) will be included. Women will be classified by their pre-pregnancy BMI and all pregnant women with an age ≥ 18 will be offered to attend the project and those who accept will be admitted. The recruitment will be performed at Holbæk Hospital and Odense University Hospital.
Key inclusion criteria (4 listed)
- Age ≥ 18
- BMI ≥ 30 Kg/m2
- BMI: 18,5-25 Kg/m2
- Understand and speak Danish and thereby be able to give confirmed consent.
Key exclusion criteria (5 listed)
- Multiple gestations
- Overweight (BMI: 25-29,9 Kg/m2)
- Alcohol or drug abuse
- Chronically diseases before pregnancy as diabetes, hypertension, or thyroid diseases
- Gastric bypass or other obesity related surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Image quality of ultrasound at 15 compared with 21 weeks of gestation.
Time frame: The participants will be examined for an hour at to different stages of the pregnancy (GA 14+0-15+0, GA 20+0-21+0)
Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.
5 secondary outcomes
Image quality of ultrasound at 13 compared with 15 weeks of gestation.
Time frame: The participants will be examined for an hour at to different stages of the pregnancy (GA 11+3 - 13+0, GA 14+0-15+0)
Analyses of BMI, visceral to subcutaneous fat ratio, distance from cutis to amnion and hip-waist ratio´s influence on image quality.
Time frame: The participants will be examined for an hour at three different stages of the pregnancy (GA 13, GA 15, GA 21 and GA 36 weeks).
Weight estimate
Time frame: The participants will be examined for an hour at GA 36 weeks. The participants will in all be followed until 6 months after birth, which is one year in all.
Amnion fluid in obese
Time frame: The participants will be examined for an hour at three different stages of the pregnancy (GA 15, GA 21, GA 36 weeks)
Crown-rump length (CRL) measurement transvaginal and abdominal
Time frame: The participants will be examined for an hour at GA 13 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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.
Lone Krebs, M.D; DSMc contact
Ida Näslund Thagaard, M.D. principal investigator
Department of obstetrics and gynecology, Holbæk Hospital, Denmark
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 and Fetal Malformation, run by Holbaek Sygehus at 1 site in Denmark.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Nov 2015. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ida Näslund Thagaard, M.D. (004522890524, idanaeslund@gmail.com/ains@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality of ultrasound at 15 compared with 21 weeks of gestation. (time frame: The participants will be examined for an hour at to different stages of the pregnancy (GA 14+0-15+0, GA 20+0-21+0)). 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 10 Nov 2015.