Fetal Growth and Placental Function in Pregnancies Complicated by Diabetes

NCT04801121 | Unknown

• 1 other identifier: N-20200065
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic pregnancies are often complicated by placental dysfunction with reduced transfer of oxygen from the mother to the fetus, which may compromise fetal growth and organ development. In diabetic pregnancies, hyperinsulinemia and hyperglycemia very often leads to fetal macrosomia. The combination of reduced placental oxygen transfer and increasing fetal demand due to fetal overgrowth may possess a particular risk of adverse pregnancy outcome. Current methods in the antenatal identification of placental dysfunction relies on estimates of fetal size and fetal wellbeing using ultrasound including Doppler flows measurements. These measurements are only indirect estimates of placental function, as no clinical method exists to assess placental function directly. In diabetic pregnancies, the estimates are further limited due to fetal overgrowth and unreliable Doppler. In addition, in diabetic pregnancies, intrauterine fetal weight estimates by ultrasound are inaccurate because of asymmetric fetal growth. Therefore, new accurate methods to assess placental function, fetal oxygenation and fetal growth in this particular group of high-risk pregnancies is highly needed. Early and precise identification of pathology in diabetes pregnancy may lead to an improved outcome in the offspring, as precise identification of pathology facilitates important obstetric decisions in regards to maternal antidiabetic treatment and timing of delivery. Resent research indicates that MRI is useful for this purpose. It is well described, that preeclampsia is associated with an increased maternal risk of cardiovascular disease later in life. Recent studies suggest, that pregestational subclinical cardiovascular dysfunction, in particular left ventricular dysfunction, may increase the risk of preeclampsia and fetal growth restriction during pregnancy. Cardiac MRI is a sensitive method to detect subclinical maternal cardiac dysfunction, which may be used in identification of high-risk pregnancies. In addition, the longitudinal design of this study allows for the investigation of cardiovascular changes during pregnancies in normal pregnancies and pregnancies complicated by diabetes. The overall aim of this study is to improve the antenatal fetal and maternal monitoring in diabetes pregnancies. Early and precise identification of pregnancy pathology provides a better basis for important obstetric decisions regarding antidiabetic treatment, monitoring intervals and timing of delivery, which leads to a better outcome for the mother and offspring. Hypothesis Project A: Placental function and fetal oxygenation in diabetic pregnancies estimated by T2\* weighted placental and fetal MRI Aim: To investigate placental function and fetal oxygenation by longitudinal T2\* weighted placental MRI and the association with pregnancy complications. Hypothesis:

• Diabetic pregnancies are characterized by placental hypoxia (low T2\* value)
• Diabetic pregnancies are characterized by fetal hypoxia (low T2\* value)
• Fetal and placental hypoxia is a risk factor of placental related complications in pregnancy such as low birth weight, preterm delivery, acute cesarean sections and preeclampsia. Project B: Fetal growth and the growth of selected fetal organs in diabetic pregnancies estimated by longitudinal MRI volumetry Aim: To investigate growth velocity of the fetus and selected fetal organs and the correlation with pregnancy complications. Hypothesis:
• Diabetic pregnancies are characterized by accelerated fetal growth in the third trimester
• Diabetic pregnancies are characterized by asymmetric growth (reduced brain/liver-volume ratio)
• Abnormal fetal growth is associated with dysregulated maternal diabetes.
• Abnormal fetal growth is a risk factor of pregnancy complications such as; macrosomia, preterm delivery and acute cesarean sections. Project C: Maternal cardiac function in diabetic pregnancies estimated by MRI Aim: To investigate maternal cardiac function and the correlation with pregnancy complications such as preeclampsia and fetal growth restriction. Hypothesis:
• Maternal cardiac function is altered in diabetes pregnancies when compared to normal pregnancies.
• Impaired cardiac function (left ventricular dysfunction) is a risk factor of preeclampsia and fetal growth restriction.

Conditions

Pregnancy in Diabetics; Placenta; Fetal Growth; Magnetic Resonance Imaging

Keywords

Pregestational diabetes; Placenta dysfunction; Placenta pathology; Abnormal fetal growth; Functional magnetic resonance imaging; 3D volume magnetic resonance imaging

Outcome Measures

Primary Outcomes (5)

• Abnormal birth weight

  Birth weight below or above normal index for gestational age (-22% - +22%)

  At birth

• Preterm delivery

  Delivery before gestational age 37+0

  At birth

• Cesarean sections

  Any elective or acute cesarean section

  At birth

• Preeclampsia

  Any degree of preeclamsia / eclampsia og HELLP

  30 weeks before birth or 5 weeks after birth

• Placental pathology

  Any abnormal placenta pathology

  Within 1 year after birth

Study Arms (2)

Pregestational diabetic pregnant

Cases: Women with type 1 or type 2 diabetes before start of pregnancy

Non-diabetic pregnant

Controls: Women without metabolic disease before start of pregnancy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women are eligibile
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with pregestational diabetes or uncomplicated pregnancies who meet the above-mentioned inclusion criteria attending their first trimester ultrasound scan at the department of Obstetrics and Gynecology, Aalborg University Hospital.

You may qualify if:

• Age \>18 years
• Singleton pregnancy

You may not qualify if:

• Fetal malformation or abnormal karyotype
• Maternal height from spine to chest \> 43 cm (for technical reasons)
• Sever claustrophobia or any other contradictions to MRI
• Women who do not read or understand Danish

Sponsors & Collaborators

• Sidsel Linneberg Rathcke: lead
• Aarhus University Hospital: collaborator
• University of Nottingham: collaborator

Study Sites (1)

Aalborg University Hospital, Department of Obstetrics and Gynecology

Aalborg, 9000, Denmark

Location

Related Publications (46)

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Related Links

• DSOG. Patoanatomisk Undersøgelse af Placenta \[Internet\]. 2016. Available from: http://gynobsguideline.dk/sandbjerg/Patoanatomi placenta.pdf

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from participant, Umbilical cord blood samples, Placental tissues biopsies

MeSH Terms

Conditions

Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sidsel L Rathcke, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 16, 2021
• Study Start: November 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: October 31, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)