Obesity Complicating Childbirth Clinical Trial
Official title:
Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
Verified date | July 2021 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | March 10, 2021 |
Est. primary completion date | March 10, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia Univeristy Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At time of delivery | |
Secondary | 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. | At time of delivery | |
Secondary | 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. | At time of delivery | |
Secondary | 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). | At time of delivery | |
Secondary | 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). | At time of delivery |
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