Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake

NCT04215107 | Unknown

• 1 other identifier: REK ref: 2018/1034B
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Aims The primary aim is to examine the relation between maternal nutrition, placental transport of nutritional substances, and fetal blood flow distribution in normal pregnancies and in pregnancies complicated by altered fetal growth. Specific aims:

1. 1.Examine the relation between fetal glucose, amino acid and lipid consumption, and ultrasound Doppler measures of fetal cerebral vascular resistance.
2. 2.Examine the influence of extended fasting for two hours compared to a standard meal in a group with appropriate fetal group on fetal liver blood flow and fetal cerebral vascular resistance. The examinations will be performed at approximately 36 weeks gestation.
3. 3.Examine the influence of a standard maternal meal on fetal liver blood flow and fetal cerebral vascular resistance in pregnancies complicated by fetal growth restriction (FGR).

Conditions

Fetal Growth Restriction

Outcome Measures

Primary Outcomes (3)

• Doppler measures of fetal cerebral vascular resistance as mean cerebral artery pulsatility index (MCA-PI)

  Examine the influence of extended fasting for two hours compared to a standard meal in a group with appropriate fetal group on fetal cerebral vascular resistance, measured as MCA-PI, ranging from 1,2-2,5. Values below 1,1 represent poor outcome. The examinations will be performed at approximately 36 weeks gestation. Examine the influence of a standard maternal meal on fetal cerebral vascular resistance, measured as MCA-PI, in pregnancies complicated by fetal growth restriction (FGR).

  2-2,5 years

• Doppler measures of fetal liver blood flow (ml/min)

  Examine the influence of extended fasting for two hours compared to a standard meal in a group with appropriate fetal group on fetal liver blood flow (ml/min) .The examinations will be performed at approximately 36 weeks gestation. Examine the influence of a standard maternal meal on fetal liver blood flow (ml/min) pregnancies complicated by fetal growth restriction (FGR).

  2-2,5 years

• Examine the relation between nutrient (glucose, amino acid and lipid) transfer to the fetus (mmol/ml), and ultrasound Doppler measures of fetal cerebral vascular resistance, measured as MCA-PI (mean cerebral artery pulsatility index

  Investigators will use the 130 fetal-maternal pairs from the "placental 4 vessel sampling method". In brief, blood samples are obtained from incoming (arterial) and outgoing (venous) vessels both at the maternal and fetal side of the placenta simultaneously during cesarean section. Nutrient concentration is measured as mmol/ml. This sample also includes doppler measures of blood flow (ml/min) in the umbilical vein (fetal side) and in the uterine artery (maternal side), and mean cerebral artery pulsatility-index (MCA-PI) which is a measurement for cerebral vascular resistance. The absolute transfer of the nutrients to the fetus is measured in mmol/min, by combining blood flow (ml/min) and nutrient concentration (mmol/ml). Investigator will examine the correlation between absolute fetal nutrients transfer (mmol/ml) and fetal cerebral vascular resistance (MCA-PI).

  1 year

Study Arms (2)

Control group

OTHER

Crossover study Group. Each patient will be examined 2 seperate days. Randomized to standard breakfast meal or prolonged fasting. The examinator will be blinded to patient meal status.

Other: Standard breakfast meal

IUGR group

OTHER

Will only be examined one day. First ultrasound during fasting, and the second ultrasound 2 hours after a standard breakfast meal.

Other: Standard breakfast meal

Interventions

Standard breakfast meal OTHER

The first ultrasound will be preformed during fasting. IUGR group will be served a standard breakfast meal, and perform the second ultrasound after 2 hours from the meal. The control group will be crossover randomized to meal or prolonged fasting. It will be performed 4 ultrasounds: during fasting and 2 hours after standard breakfast meal. During fasting and during prolonged fasting.

Control group; IUGR group

Eligibility Criteria

• Age: 16 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Control group: Pregnant caucasian women With singleton fetus, and without any disease which can influence placental function

You may not qualify if:

• Food allergy
• use of medicine which can influence placental function

Sponsors & Collaborators

• Guttorm Haugen: lead

Study Sites (1)

Oslo university hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guttorm Haugen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saba M Zahid

CONTACT

004792815971; smunee@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: January 2, 2020
• Study Start: October 11, 2018
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

NO (1)