Trials / Terminated
TerminatedNCT04180566
Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes
Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Columbia University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Ultrasound Examination | Includes a regular growth ultrasound examination. |
| OTHER | 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). |
Timeline
- Start date
- 2020-02-04
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
- First posted
- 2019-11-27
- Last updated
- 2021-07-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04180566. Inclusion in this directory is not an endorsement.