Obesity Complicating ChildbirthNCT04180566
Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes
A study testing Ultrasound Examination and Antenatal Testing (biophysical profile) in people with Obesity Complicating Childbirth, run by Columbia University at 1 site in United States.
Trial summary
The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity Complicating Childbirth
- What is being tested?
- Ultrasound Examination and Antenatal Testing (biophysical profile)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 10 Mar 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women at or over 18 years of age
- Singleton pregnancy with no major fetal anomalies
- Pregnancies and gestational age will be well dated
- Obese with BMI 30-40kg/m2
Who cannot join
- Women with any complications at time of randomization that would require antenatal testing in the third trimester as per ACOG guidelines including: hypertension, systemic lupus erythematosus, chronic renal disease, antiphospholipid syndromes, hyperthyroidism poorly controlled, hemoglobinopathies, cyanotic heart disease, gestational hypertension, pre-eclampsia, gestational diabetes medication controlled, oligohydramnios, intrauterine growth restriction before randomization, isoimmunization, history of fetal demise
- Women with indication for weekly testing as per local protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Univeristy Irving Medical Center
New York, New York, 10032
About this study
Official title: Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.
Read the detailed description
Over the last decade, the prevalence of obesity has dramatically increased in women in reproductive age. It is well known that obesity has been associated with increased risk of antenatal complications, maternal and perinatal morbidity, including higher risk of stillbirth. Studies including obese women without other antepartum comorbidities have shown that up to 11% of pregnancies are complicated with fluid and fetal growth abnormalities. According to American College of Obstetricians and Gynecologists (ACOG) guidelines, antepartum surveillance has not been proven to improve pregnancy outcomes in such cases and no specific recommendations for antepartum surveillance in obese women have been established.
- Conditions
- Obesity Complicating Childbirth
- Being tested
- Ultrasound Examination, Antenatal Testing (biophysical profile)
- Keywords
- Pregnant, Pregnancy, Ultrasound, Antepartum testing, Neonatal outcome, Antenatal complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ExaminationOther
Includes a regular growth ultrasound examination.
Antenatal Testing (biophysical profile)Other
Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby).
| Study group | Role | What they receive |
|---|---|---|
| Weekly antenatal testing | Other | Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive weekly antenatal testing (biophysical profile) starting at 34 weeks as well as growth ultrasound every 4 weeks. Receives: Other: Antenatal Testing (biophysical profile) |
| Growth ultrasound examination every 4 weeks | Other | Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive ultrasound examination (growth ultrasound) every 4 weeks starting at 34 weeks. Receives: Other: Ultrasound Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average gestational age at delivery of participating women's babies
This is to measure the number of weeks that the baby has been in the uterus. It is measured from the first day of the woman's last menstrual cycle to the date of delivery. A normal pregnancy can range from 38 to 42 weeks. A significant delay in gestational age of delivery would be > 7 days out of this range.
Measured: At time of delivery
Secondary outcomes (4)
Average birth weight of participating women's babies
This is to measure the body weight of a baby at birth. The average baby weighs about 7.5 pounds - though the range of normal is between 5.8 and 10 pounds.
Measured: At time of delivery
Number of participating women who experienced composite maternal morbidity
Composite maternal morbidity is defined as any of the following: chorioamnionitis, endometritis, cesarean section in labor, wound infection, transfusion, hemorrhage, deep venous thrombosis or pulmonary embolism, admission to ICU or death.
Measured: At time of delivery
Number of participating women whose babies experienced composite neonatal morbidity
Composite neonatal morbidity is defined as any of the following: stillbirth after randomization, neonatal death within 28 days from birth, respiratory distress syndrome, Transient tachypnea of the newborn, hypoglycemia, sepsis, seizures, necrotizing enterocolitis, hypoxic ischemic encephalopathy, cardiopulmonary resuscitation or ventilator support within 24 h of birth, arterial blood pH<7, 5 min Apgar score <3, ICU admission, prolonged hospitalization (5 days or longer).
Measured: At time of delivery
Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth
A composite of abnormalities of fluid volume and growth is defined as any of the following: oligohydramnios (AFI<5 or maximum vertical pocket (MVP) < 2) or polyhydramnios (AFI>24 or MVP>8); fetal growth restriction (EFW<10% or AC<5%) ; or large for gestational age (EFW>90%), macrosomia (EFW>4,000 grams).
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start4 Feb 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Complicating ChildbirthStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Gyamfi-Bannerman, MD, MSc, Principal investigator, Professor of Obstetrics/Gyn, Columbia UniversityMaria Andrikopoulou, MD, PhD, Study chair, Postdoctoral Clinical Fellow in the Department of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180566
- Sponsor's protocol ID
- AAAS5275
- Status last verified
- Jul 2021
- First submitted
- 26 Nov 2019
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04180566
- Acronym / sponsor ID
- AAAS5275
- Conditions
- Obesity Complicating Childbirth
- Keywords
- Pregnant, Pregnancy, Ultrasound, Antepartum testing, Neonatal outcome, Antenatal complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 27 Nov 2019 (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.
The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.
Detailed description
Over the last decade, the prevalence of obesity has dramatically increased in women in reproductive age. It is well known that obesity has been associated with increased risk of antenatal complications, maternal and perinatal morbidity, including higher risk of stillbirth. Studies including obese women without other antepartum comorbidities have shown that up to 11% of pregnancies are complicated with fluid and fetal growth abnormalities. According to American College of Obstetricians and Gynecologists (ACOG) guidelines, antepartum surveillance has not been proven to improve pregnancy outcomes in such cases and no specific recommendations for antepartum surveillance in obese women have been established.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly antenatal testing | Other | Other: Antenatal Testing (biophysical profile)Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive weekly antenatal testing (biophysical profile) starting at 34 weeks as well as growth ultrasound every 4 weeks. |
| Growth ultrasound examination every 4 weeks | Other | Other: Ultrasound ExaminationWomen with BMI 30-40 between 20 and 34.6 weeks of gestation will receive ultrasound examination (growth ultrasound) every 4 weeks starting at 34 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women at or over 18 years of age
- Singleton pregnancy with no major fetal anomalies
- Pregnancies and gestational age will be well dated
- Obese with BMI 30-40kg/m2
Key exclusion criteria (2 listed)
- Women with any complications at time of randomization that would require antenatal testing in the third trimester as per ACOG guidelines including: hypertension, systemic lupus erythematosus, chronic renal disease, antiphospholipid syndromes, hyperthyroidism poorly controlled, hemoglobinopathies, cyanotic heart disease, gestational hypertension, pre-eclampsia, gestational diabetes medication controlled, oligohydramnios, intrauterine growth restriction before randomization, isoimmunization, history of fetal demise
- Women with indication for weekly testing as per local protocol
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 |
|---|---|---|
| Ultrasound ExaminationIncludes a regular growth ultrasound examination. | Other | Growth ultrasound examination every 4 weeks |
| Antenatal Testing (biophysical profile)Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby). | Other | Weekly antenatal testing |
Primary outcome
Average gestational age at delivery of participating women's babies
Time frame: At time of delivery
This is to measure the number of weeks that the baby has been in the uterus. It is measured from the first day of the woman's last menstrual cycle to the date of delivery. A normal pregnancy can range from 38 to 42 weeks. A significant delay in gestational age of delivery would be > 7 days out of this range.
4 secondary outcomes
Average birth weight of participating women's babies
Time frame: At time of delivery
Number of participating women who experienced composite maternal morbidity
Time frame: At time of delivery
Number of participating women whose babies experienced composite neonatal morbidity
Time frame: At time of delivery
Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth
Time frame: At time of delivery
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Cynthia Gyamfi-Bannerman, MD, MSc principal investigator
Professor of Obstetrics/Gyn, Columbia University
Maria Andrikopoulou, MD, PhD study chair
Postdoctoral Clinical Fellow in the Department of Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Examination and Antenatal Testing (biophysical profile) in people with Obesity Complicating Childbirth, run by Columbia University at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 7 Jul 2021. 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 United States. 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 was stopped early (reason given: Poor enrollment). Results are not available in the source record.
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?
Average gestational age at delivery of participating women's babies (time frame: At time of delivery). 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 7 Jul 2021.