Assessing placental health in pregnancies with growth restriction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.