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

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ClinicalTrials.gov Identifier: NCT02702999
Recruitment Status : Completed
First Posted : March 9, 2016
Results First Posted : August 7, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Olaide Ashimi Balogun, The University of Texas Health Science Center, Houston

Study Description
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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?

Condition or disease Intervention/treatment Phase
Uncomplicated Pregnancy Abnormal Fetal Growth or Fluid Device: Clinically-indicated ultrasound Device: Serial third trimester ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial (UP Trial)
Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Fetal Growth Restriction [ Time Frame: 30 to 38 weeks gestational age ]
  2. Number of Participants With Large for Gestational Age Fetuses [ Time Frame: 30 to 38 weeks gestational age ]
  3. Number of Participates With Oligohydraminos [ Time Frame: 30 to 38 weeks gestational age ]

    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.


  4. Number of Participates With Polyhydraminos [ Time Frame: 30 to 38 weeks gestational age ]

    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.



Secondary Outcome Measures :
  1. Number of Participants With Composite Neonatal Morbidity [ Time Frame: From time of delivery to 28 days after delivery ]
    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.

  2. Number of Participants With Composite Maternal Morbidity [ Time Frame: From time of delivery to discharge (average time of discharge is 4 days after delivery) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702999


Locations
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United States, Texas
UT Physicians
Bellaire, Texas, United States, 77401
University of Texas at Houston Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Olaide A Ashimi Balogun, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Olaide Ashimi Balogun, The University of Texas Health Science Center, Houston:
Study Protocol and Statistical Analysis Plan  [PDF] May 3, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Olaide Ashimi Balogun, Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02702999    
Other Study ID Numbers: HSC-MS-16-0084
First Posted: March 9, 2016    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No