Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP)

The University of Texas System (UT)

Status: Completed

Conditions: Abnormal Fetal Growth or Fluid; Uncomplicated Pregnancy

Treatments: Device: Clinically-indicated ultrasound; Device: Serial third trimester ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02702999

HSC-MS-16-0084

Details and patient eligibility

About

The purpose of this study is to see whether women at a gestational age of 30 weeks or more without comorbidities, does performance of serial 3rd trimester growth ultrasounds increase the frequency of identifying abnormalities in fetal growth or amniotic fluid, when compared with women who only receive indicated ultrasounds?

Enrollment: 206 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Maternal age of 18 at the time of consent
• Singleton gestation

Exclusion criteria

• First sonographic examination after 20 weeks
• Women with any of the following co-morbidities: Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma), Cerclage in the index pregnancy, Diabetes mellitus-gestational or pre-gestational, Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia), Hypertension (chronic or pregnancy induced) before enrollment, HIV (human immunodeficiency virus), Institutionalized individuals (prisoners), Prior obstetric history of: [1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia], eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death, Preterm labor or ruptured membranes before enrollment, Psychiatric disorder (bipolar, depression) on medication, Placenta previa / 3rd trimester bleeding, Renal insufficiency (serum creatinine > 1.5 mg/dL), Restrictive lung disease, Fetal red blood cell isoimmunization, Seizure disorder on medication, Thyroid disease on medication, Body Mass Index (BMI) above 40 kg/m2
• Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects
• Unable to understand consent in English or Spanish

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Routine third trimester care

Active Comparator group

Description:

Routine third trimester care with clinically-indicated ultrasound (control)

Treatment:

Device: Clinically-indicated ultrasound

Serial third trimester ultrasound

Experimental group

Description:

Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).

Treatment:

Device: Serial third trimester ultrasound