Obesity in PregnancyATOWSNCT02821988
Antenatal Testing in Obese Woman, is it Really Necessary?
A study testing External fetal monitor for Nonstress test and Ultrasonography for Biophysical profile in people with Obesity in Pregnancy, run by University of Tennessee.
Trial summary
It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity in Pregnancy
- What is being tested?
- External fetal monitor for Nonstress test and Ultrasonography for Biophysical profile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to May 2017
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- less then 32 weeks gestation BMI > 30kg/m2 English speaking
Who cannot join
- age < 18 age >45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age >32 weeks
Trial locations and contacts
No sites are listed yet.
Luis Gomez, MD contact
About this study
It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).
Read the detailed description
- Purpose: To determine if antenatal testing improves outcomes in obese pregnant women
- Rationale: It has been well established that obese pregnant women are at increase risk of stillbirth compared to matched non obese controls. This relative risk is increased not only with increasing gestational age in obese women but with increasing severity of obesity. The increased risk of stillbirth has led some obstetricians to begin antenatal testing in obese women; however, there is little evidence that antenatal fetal surveillance improves outcomes.
- Study/Project Population: Pregnant women before 32 weeks of gestation with an initial BMI >30kg/m2
- Research Design: Randomized Controlled Trial
- Study/Project Procedures: Patients will be randomized to one of three groups: daily kick counts only, nonstress test, amniotic fluid index, and daily kick counts, and biophysical profile and daily kick counts. These patients will be randomly assigned a group in a 1:1:1 ratio using a random number generator available online. Patients assigned to the daily kick counts only group will be called weekly to ensure they are doing daily kick counts. If they are noncompliant, they will be removed from the study and will undergo nonstress tests if they meet the initial BMI criteria as is the standard practice at our institution.
- Outcomes Measured: Stillbirth, induction of labor, mode of delivery, neonatal intensive care unit admission, AGPARs <7 at 5 minutes of life
- Conditions
- Obesity in Pregnancy
- Being tested
- External fetal monitor for Nonstress test, Ultrasonography for Biophysical profile
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External fetal monitor for Nonstress testDevice
Ultrasonography for Biophysical profileDevice
| Study group | Role | What they receive |
|---|---|---|
| Nonstress test | Experimental | Subjects will undergo weekly nonstress tests beginning at 32 weeks until delivery in addition to monitoring fetal kick counts.
A nonstress test is a test in which an external fetal monitor is placed on the mother to defect the fetal heart rate for 20 to 40 minutes. A test is considered reactive if there are more than 2 accelerations in fetal heart rate defined as an increase of at least 15 beats per minute lasting at least 15 seconds in a 20 minute period. Receives: Device: External fetal monitor for Nonstress test |
| Biophysical profile | Experimental | Subjects will undergo weekly biophysical profile testing beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A Biophysical profile is a test using real time ultrasonography to determine the presence of absence of certain components of fetal well being. There components include: an episode of fetal breathing lasting at least 30 seconds, 3 or more discrete body movements, 1 or more episodes of extension of a fetal extremity with return to flexion, and determination of amniotic fluid volume to detect a maximum vertical pocket of >2cm. The duration of this test is no more than 30 minutes. Receives: Device: Ultrasonography for Biophysical profile |
| Kick counts only | No intervention | Subjects will monitor fetal kick counts only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stillbirth
demise of infant prior to delivery as verified by ultrasonography
Measured: until delivery, up to 41 weeks
Mode of delivery
whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded
Measured: at delivery, up to 41 weeks
Secondary outcomes (2)
Neonatal intensive care unit admission admission
Measured: at delivery, up to 41 weeks
Apgar score of less than 7 at 5 minutes
Measured: at delivery, up to 41 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity in PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Regional One Health
- Responsible party
- Principal investigator, Laura Grese, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821988
- Sponsor's protocol ID
- 16-04574-XP
- Acronym
- ATOWS
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Testing in Obese Woman, is it Really Necessary?
- ClinicalTrials.gov ID
- NCT02821988
- Acronym / sponsor ID
- ATOWS / 16-04574-XP
- Conditions
- Obesity in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Regional One Health
- Study start
- Jul 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 4 Jul 2016 (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.
It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).
Detailed description
- Purpose: To determine if antenatal testing improves outcomes in obese pregnant women
- Rationale: It has been well established that obese pregnant women are at increase risk of stillbirth compared to matched non obese controls. This relative risk is increased not only with increasing gestational age in obese women but with increasing severity of obesity. The increased risk of stillbirth has led some obstetricians to begin antenatal testing in obese women; however, there is little evidence that antenatal fetal surveillance improves outcomes.
- Study/Project Population: Pregnant women before 32 weeks of gestation with an initial BMI >30kg/m2
- Research Design: Randomized Controlled Trial
- Study/Project Procedures: Patients will be randomized to one of three groups: daily kick counts only, nonstress test, amniotic fluid index, and daily kick counts, and biophysical profile and daily kick counts. These patients will be randomly assigned a group in a 1:1:1 ratio using a random number generator available online. Patients assigned to the daily kick counts only group will be called weekly to ensure they are doing daily kick counts. If they are noncompliant, they will be removed from the study and will undergo nonstress tests if they meet the initial BMI criteria as is the standard practice at our institution.
- Outcomes Measured: Stillbirth, induction of labor, mode of delivery, neonatal intensive care unit admission, AGPARs <7 at 5 minutes of life
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nonstress test | Experimental | Device: External fetal monitor for Nonstress testSubjects will undergo weekly nonstress tests beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A nonstress test is a test in which an external fetal monitor is placed on the mother to defect the fetal heart rate for 20 to 40 minutes. A test is considered reactive if there are more than 2 accelerations in fetal heart rate defined as an increase of at least 15 beats per minute lasting at least 15 seconds in a 20 minute period. |
| Biophysical profile | Experimental | Device: Ultrasonography for Biophysical profileSubjects will undergo weekly biophysical profile testing beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A Biophysical profile is a test using real time ultrasonography to determine the presence of absence of certain components of fetal well being. There components include: an episode of fetal breathing lasting at least 30 seconds, 3 or more discrete body movements, 1 or more episodes of extension of a fetal extremity with return to flexion, and determination of amniotic fluid volume to detect a maximum vertical pocket of >2cm. The duration of this test is no more than 30 minutes. |
| Kick counts only | No intervention | –Subjects will monitor fetal kick counts only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- less then 32 weeks gestation BMI > 30kg/m2 English speaking
Key exclusion criteria (1 listed)
- age < 18 age >45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age >32 weeks
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 |
|---|---|---|
| External fetal monitor for Nonstress test | Device | Nonstress test |
| Ultrasonography for Biophysical profile | Device | Biophysical profile |
Primary outcome
Stillbirth
Time frame: until delivery, up to 41 weeks
demise of infant prior to delivery as verified by ultrasonography
Mode of delivery
Time frame: at delivery, up to 41 weeks
whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded
2 secondary outcomes
Neonatal intensive care unit admission admission
Time frame: at delivery, up to 41 weeks
Apgar score of less than 7 at 5 minutes
Time frame: at delivery, up to 41 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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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.
Luis Gomez, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing External fetal monitor for Nonstress test and Ultrasonography for Biophysical profile in people with Obesity in Pregnancy, run by University of Tennessee.
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 1 inclusion and 1 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Laura Grese, MD (4235712990, lgrese@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stillbirth (time frame: until delivery, up to 41 weeks). The study lists 2 primary outcomes in all. 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 4 Jul 2016.