Assessing placental health in pregnancies with growth restriction

MRI Assessment of Placental Health

This study is trying to find better ways to decide when to deliver babies at risk of stillbirth due to growth issues by looking at how well the placenta is working in pregnant women with these conditions.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT02297724 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop methods for informed decision-making regarding the delivery timing of fetuses at increased risk of stillbirth due to intrauterine growth restriction (IUGR). It focuses on characterizing placental health by assessing the efficiency of oxygen transport, which is crucial for fetal development. The study involves pregnant mothers with either twin or singleton gestations diagnosed with IUGR based on ultrasound findings. By evaluating placental pathologies and their impact on maternal-fetal exchange, the researchers hope to improve outcomes for affected pregnancies.

Who should consider this trial

Good fit: Ideal candidates include pregnant women aged 18 to 45 with singleton or twin gestations diagnosed with IUGR based on specific ultrasound criteria.

Not a fit: Patients with fetuses that have chromosomal anomalies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better management strategies for pregnancies affected by IUGR, potentially reducing the risk of stillbirth.

How similar studies have performed: Other studies have explored placental health in relation to IUGR, but this specific approach to assessing oxygen transport efficiency is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The pregnant mother with twin gestation with diagnosis of selective IUGR based upon obstetrical US findings as following:

   * Proven monochorionicity / dichorionicity
   * Discordance in estimated fetal weight (EFW). Growth restriction (\<10 percentile of norm) in one or both fetus(es) AND/OR growth discordance (\> or = 20%) between twin fetuses.
2. The pregnant mother with singleton gestation with diagnosis of IUGR based upon obstetrical US findings as following:

   * Proven singleton gestation
   * Growth restriction of fetus (\<10 percentile of norm)
   * Doppler measurements that indicates placental insufficiency: umbilical artery, middle cerebral artery, uterine artery; or oligohydramnios.
3. Gestational age: Bigger than 18 weeks.
4. Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal MRI study.

Exclusion Criteria:

Fetuses/infants with the following features will be excluded.

1. Fetus/infant with chromosomal anomalies or known genetic disorders.
2. Fetus/infant with other major congenital malformation.
3. Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient, quality or completeness of the data.

Pregnant mothers with the following features will be excluded.

1. Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).
2. Mothers with claustrophobia
3. Mothers medically unstable for the MRI study

Where this trial is running

Boston, Massachusetts and 1 other locations

• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• Hospital Universitario de Fuenlabrada — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Patricia E Grant, MD — Boston Children's Hospital

Conditions Intrauterine Growth Restriction