Clinical trial NCT02702999: Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial
Official title: Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncomplicated Pregnancy
Abnormal Fetal Growth or Fluid
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Fetal Growth Restriction
timeFrame: 30 to 38 weeks gestational age
measure: Number of Participants With Large for Gestational Age Fetuses
timeFrame: 30 to 38 weeks gestational age
measure: Number of Participates With Oligohydraminos
timeFrame: 30 to 38 weeks gestational age
measure: Number of Participates With Polyhydraminos
timeFrame: 30 to 38 weeks gestational age
Secondary outcomes:
measure: Number of Participants With Composite Neonatal Morbidity
timeFrame: From time of delivery to 28 days after delivery
measure: Number of Participants With Composite Maternal Morbidity
timeFrame: From time of delivery to discharge (average time of discharge is 4 days after delivery)
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: UT Physicians
state: Texas
city: Houston
country: United States
facility: University of Texas at Houston Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Olaide A Ashimi Balogun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashimi Balogun O, Sibai BM, Pedroza C, Blackwell SC, Barrett TL, Chauhan SP. Serial Third-Trimester Ultrasonography Compared With Routine Care in Uncomplicated Pregnancies: A Randomized Controlled Trial. Obstet Gynecol. 2018 Dec;132(6):1358-1367. doi: 10.1097/AOG.0000000000002970.