N/A
N=206
Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial
Uncomplicated Pregnancy · Abnormal Fetal Growth or Fluid
Bottom Line
View on ClinicalTrials.gov: NCT02702999 ↗Enrolled (actual)
206
Serious AEs
0.5%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Fetal Growth Restriction — 2; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinically-indicated ultrasound (Device); Serial third trimester ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fetal Growth Restriction |
2; 8 | — |
| PRIMARY Number of Participants With Large for Gestational Age Fetuses |
2; 8 | — |
| PRIMARY Number of Participates With Oligohydraminos |
2; 4 | — |
| PRIMARY Number of Participates With Polyhydraminos |
2; 11 | — |
| SECONDARY Number of Participants With Composite Neonatal Morbidity |
4; 1 | — |
| SECONDARY Number of Participants With Composite Maternal Morbidity |
9; 9 | — |
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
Data sourced from ClinicalTrials.gov (NCT02702999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.