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

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

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?

Study Overview

• Status: Completed
• Conditions: Uncomplicated Pregnancy; Abnormal Fetal Growth or Fluid
• Intervention / Treatment: Device: Clinically-indicated ultrasound; Device: Serial third trimester ultrasound

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Bellaire, Texas, United States, 77401
      • UT Physicians
    • Houston, Texas, United States, 77030
      • University of Texas at Houston Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine third trimester care; Routine third trimester care with clinically-indicated ultrasound (control)	Device: Clinically-indicated ultrasound; Routine third trimester care with clinically-indicated ultrasound (control)
Experimental: Serial third trimester ultrasound; 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).	Device: Serial third trimester ultrasound; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Fetal Growth Restriction		30 to 38 weeks gestational age
Number of Participants With Large for Gestational Age Fetuses		30 to 38 weeks gestational age
Number of Participates With Oligohydraminos	Oligohydramnios is a condition in pregnancy characterized by a deficiency of amniotic fluid. Amniotic fluid was assessed using the amniotic fluid index (AFI) or maximum vertical pocket (MVP). Oligohydramnios was defined as AFI less than or equal to 5.0 cm or MVP less than or equal to 2.0 cm. AFI is the sum of the vertical length of the deepest, unobstructed pocket of amniotic fluid in each of the 4 quadrants of the pregnant uterus. An AFI of less than or equal to 5cm is considered low amniotic fluid, and an AFI greater than or equal to 24cm is considered high amniotic fluid. MVP is the vertical length of the single deepest pocket of amniotic fluid. An MVP less than or equal to 2cm is considered to be low amniotic fluid and an MVP of 8cm or greater is considered to be high amniotic fluid. Both low and high amniotic fluid levels are worse outcomes than having normal amniotic fluid levels.	30 to 38 weeks gestational age
Number of Participates With Polyhydraminos	Polyhydraminos is a condition in pregnancy characterized by an excess of amniotic fluid. Amniotic fluid was assessed using either the amniotic fluid index (AFI) or maximum vertical pocket (MVP). Polyhydramnios was defined as AFI greater than or equal to 24.0 cm or MVP greater than or equal to 8.0 cm. AFI is the sum of the vertical length of the deepest, unobstructed pocket of amniotic fluid in each of the 4 quadrants of the pregnant uterus. An AFI of less than or equal to 5cm is considered low amniotic fluid, and an AFI greater than or equal to 24cm is considered high amniotic fluid. MVP is the vertical length of the single deepest pocket of amniotic fluid. An MVP less than or equal to 2cm is considered to be low amniotic fluid and an MVP of 8cm or greater is considered to be high amniotic fluid. Both low and high amniotic fluid levels are worse outcomes than having normal amniotic fluid levels.	30 to 38 weeks gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite Neonatal Morbidity	Composite Neonatal Morbidity is defined as the presence of one or more of the following: 1) Apgar score < 5 at 5 min; 2) umbilical arterial pH < 7.00; 3) intraventricular hemorrhage grade III or IV; 4) periventricular leukomalacia; 5) intubation for over 24 hrs; 6) necrotizing enterocolitis grade 2 or 3; 7) stillbirth; or 8) death within 28 days of birth.	From time of delivery to 28 days after delivery
Number of Participants With Composite Maternal Morbidity	Composite Maternal Morbidity is defined as the presence of one of more of the following: 1) chorioamnionitis; 2) cesarean delivery in labor; 3) wound infection; 4) transfusion; 5) deep venous thrombus or pulmonary embolism; 6) admission to intensive care unit; 7) postpartum hemorrhage; or 8) death.	From time of delivery to discharge (average time of discharge is 4 days after delivery)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Olaide A Ashimi Balogun, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-16-0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO