Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes

Obesity Complicating Childbirth Clinical Trial

Official title:

Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04180566
• Other study ID #: AAAS5275
• Status: Terminated
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: July 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obesity Complicating Childbirth

Intervention

Other:
• Ultrasound Examination
Includes a regular growth ultrasound examination.
• 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).

Locations

Country	Name	City	State
United States	Columbia Univeristy Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

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