Obesity Complicating Childbirth
Conditions
Keywords
Pregnant, Pregnancy, Ultrasound, Antepartum testing, Neonatal outcome, Antenatal complications
Brief 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.
Interventions
OTHERUltrasound Examination
Includes a regular growth ultrasound examination.
OTHERAntenatal 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).
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average gestational age at delivery of participating women's babies | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participating women who experienced composite maternal morbidity | At time of delivery | 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. |
| Average birth weight of participating women's babies | At time of delivery | 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. |
| Number of participating women whose babies experienced composite neonatal morbidity | At time of delivery | 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). |
| Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth | At time of delivery | 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). |
Countries
United States
Outcome results
None listed