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

NCT02702999 | Completed Results

• 1 other identifier: HSC-MS-16-0084
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

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?

Conditions

Uncomplicated Pregnancy; Abnormal Fetal Growth or Fluid

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Number of Participants With Composite Neonatal Morbidity

  From time of delivery to 28 days after delivery

• Number of Participants With Composite Maternal Morbidity

  From time of delivery to discharge (average time of discharge is 4 days after delivery)

Study Arms (2)

Routine third trimester care

ACTIVE COMPARATOR

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

Device: Clinically-indicated ultrasound

Serial third trimester ultrasound

EXPERIMENTAL

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

Interventions

Clinically-indicated ultrasound DEVICE

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

Routine third trimester care

Serial third trimester ultrasound DEVICE

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).

Serial third trimester ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

UT Physicians

Bellaire, Texas, 77401, United States

Location

University of Texas at Houston Health Science Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 30399092 DERIVED

Limitations and Caveats

not powered to detect differences in neonatal outcomes; all sonographic exams were done by a Registered Diagnostic Medical Sonographer (RDMS), and thus findings may not apply to those with sonographic exams done by clinician

Results Point of Contact

• Title: Olaide Azizat Ashimi Balogun, MD
• Organization: The University of Texas Health Science Center at Houston

Olaide.A.Ashimi@uth.tmc.edu

(713) 500-6412

Study Officials

• Olaide A Ashimi Balogun, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 9, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 5, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)