N/A
Completed N=60
Predicting Placental Pathologies by Ultrasound Imaging
Intrauterine Growth Restriction · Villitis · IUGR
Source: ClinicalTrials.gov NCT04506970 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Uterine Artery Indices Completed — 13; 3 Participants
Summary
Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase in inflammatory T cells in the placenta known as villitis of unknown etiology (VUE) is observed in many IUGR infants. The investigators aim to develop ultrasound methods for diagnosing VUE to understand it's role in IUGR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Uterine Artery Indices Completed |
13; 3 | — |
| PRIMARY Number of Patients With Umbilical Artery Indices Completed |
29; 8 | — |
| PRIMARY Systolic(S)/Diastolic(D) Ratio |
2.8; 2.3 | — |
| PRIMARY Resistance Index (RI) |
0.6; 0.6 | — |
| PRIMARY Pulsatility Index (PI) |
1.0; 0.7 | — |
| PRIMARY Number of Participants With Placental Pathology Indicating Chronic Villitis |
8; 7 | — |
| SECONDARY Gestational Age at Birth |
39.2; 38.1 | — |
| SECONDARY Preterm Labor |
2; 0 | — |
| SECONDARY Birth Weight of Infant |
2598; 3348.5 | — |
Eligibility Criteria
Inclusion Criteria for IUGR study cohort:
- Pregnancy > 28 weeks gestation
- Diagnosis of Intrauterine Growth Restriction (IUGR) before admission for labor and delivery
- Weight > 110 lbs (50 kg)
- Ability to understand and provide written informed consent
Inclusion Criteria for control cohort:
- Pregnancy > 28 weeks gestation
- No known pregnancy complications at prenatal obstetrical visit (+/- 1 week gestational age of matched subject in IUGR cohort)
- Weight > 110 lbs (50 kg)
- Ability to understand and provide written informed consent
Exclusion Criteria
- Known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes)
- Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension
- Chronic, active viral infections, including HIV-1/2, HTLV-1/2, Hepatitis B or C
- Solid organ or transplant recipient
- Current smokers (tobacco exposure within 30 days of registration)
- Conceptions from assisted reproductive technology (prior Clomid use is allowed)
- Multiple gestation
- Ruptured membranes
- Pregnancy <28 weeks gestation
- Not planning on delivering at Mayo Clinic
Data sourced from ClinicalTrials.gov (NCT04506970). 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. Informational only — not medical advice.