Fetal Growth RestrictionNCT04215107
Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake
A study testing Standard breakfast meal in people with Fetal Growth Restriction, run by Guttorm Haugen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 58 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction
- What is being tested?
- Standard breakfast meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 11 Oct 2018to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 58 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Control group: Pregnant caucasian women With singleton fetus, and without any disease which can influence placental function
Who cannot join
- Food allergy
- use of medicine which can influence placental function
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- Examine the relation between fetal glucose, amino acid and lipid consumption, and ultrasound Doppler measures of fetal cerebral vascular resistance.
- 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.
- 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).
Study 1: Investigator will use the 130 fetal-maternal pairs from the "placental 4 vessel sampling method" (see below) which includes measures on fetal blood flow distribution. Some calculations will be performed on the restricted cohort of 70 pregnancies who also includes maternal blood flow measures.
Study 2: A limitation of investigators previous studies on the influence of glucose intake or a regular maternal meal on fetal blood flow distribution in healthy pregnancies with appropriate fetal growth is the lack of a control group without food intake (extended fasting for two hours). To serve as participants own control the included participants will meet for examinations at two different days (one with food intake and one with extended fasting) within a few days interval. Participants will be examined in the morning and two hours after food intake or after two hours extended fasting. The study will include 25 pregnancies with gestational age about 36 weeks
Study 3: Investigator will include approximately 55 women (see power calculation below) with pregnancies complicated by FGR defined as estimated birth weight (EFW) below the 3rd percentile and/or EFW below the 10th percentile and sign of fetal Doppler blood flow redistribution representing possible fetal compromise . Investigator hypothesize that there will be no reduction in fetal cerebral vascular resistance (measured as change in MCA-PI from before to after food intake). Fetal liver blood flow will also be measured.
Methods The "Placental 4 vessel sampling method" This method has recently been developed by investigators research group and described in recent publications. 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. Samples have been taken from women with normal pregnancies but with a range of BMI and metabolic profiles: the physiological range group (undergoing cesarean delivery on own request).
Investigators have a complete dataset including blood sampling and fetal blood flow measurements in the UV, DV and MCA-PI in 130 women. Further, investigators have maternal blood flow measures in 70 of these pregnancies.
Doppler blood flow measurements Doppler blood flow measurements will be performed in the morning immediately before (fasting state) and after a standard breakfast meal (SBM) (approximately120 min). Internal vessel diameter (D) and time-averaged maximum velocity (TAMX) will be measured in the straight portion of the intra-abdominal UV and at the inlet of DV, respectively.
In the MCA Doppler velocity waveforms are sampled from the proximal part emerging from the circle of Willis . MCA in the hemisphere near the transducer will be used unless there are better insonation properties in the opposite hemisphere. Umbilical artery Doppler traces will be sampled in a free-floating loop. The Doppler tracings will be used to measure fetal heart rate (FHR). All measurements will be performed during periods of fetal quiescence.
- Conditions
- Fetal Growth Restriction
- Being tested
- Standard breakfast meal
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard breakfast mealOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard breakfast meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start11 Oct 2018
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guttorm Haugen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guttorm Haugen, Oslo University Hospital
- Investigators
- Guttorm Haugen, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215107
- Sponsor's protocol ID
- REK ref: 2018/1034B
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake
- ClinicalTrials.gov ID
- NCT04215107
- Acronym / sponsor ID
- REK ref: 2018/1034B
- Conditions
- Fetal Growth Restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guttorm HaugenUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Examine the relation between fetal glucose, amino acid and lipid consumption, and ultrasound Doppler measures of fetal cerebral vascular resistance.
- 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.
- 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).
Study 1: Investigator will use the 130 fetal-maternal pairs from the "placental 4 vessel sampling method" (see below) which includes measures on fetal blood flow distribution. Some calculations will be performed on the restricted cohort of 70 pregnancies who also includes maternal blood flow measures.
Study 2: A limitation of investigators previous studies on the influence of glucose intake or a regular maternal meal on fetal blood flow distribution in healthy pregnancies with appropriate fetal growth is the lack of a control group without food intake (extended fasting for two hours). To serve as participants own control the included participants will meet for examinations at two different days (one with food intake and one with extended fasting) within a few days interval. Participants will be examined in the morning and two hours after food intake or after two hours extended fasting. The study will include 25 pregnancies with gestational age about 36 weeks
Study 3: Investigator will include approximately 55 women (see power calculation below) with pregnancies complicated by FGR defined as estimated birth weight (EFW) below the 3rd percentile and/or EFW below the 10th percentile and sign of fetal Doppler blood flow redistribution representing possible fetal compromise . Investigator hypothesize that there will be no reduction in fetal cerebral vascular resistance (measured as change in MCA-PI from before to after food intake). Fetal liver blood flow will also be measured.
Methods The "Placental 4 vessel sampling method" This method has recently been developed by investigators research group and described in recent publications. 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. Samples have been taken from women with normal pregnancies but with a range of BMI and metabolic profiles: the physiological range group (undergoing cesarean delivery on own request).
Investigators have a complete dataset including blood sampling and fetal blood flow measurements in the UV, DV and MCA-PI in 130 women. Further, investigators have maternal blood flow measures in 70 of these pregnancies.
Doppler blood flow measurements Doppler blood flow measurements will be performed in the morning immediately before (fasting state) and after a standard breakfast meal (SBM) (approximately120 min). Internal vessel diameter (D) and time-averaged maximum velocity (TAMX) will be measured in the straight portion of the intra-abdominal UV and at the inlet of DV, respectively.
In the MCA Doppler velocity waveforms are sampled from the proximal part emerging from the circle of Willis . MCA in the hemisphere near the transducer will be used unless there are better insonation properties in the opposite hemisphere. Umbilical artery Doppler traces will be sampled in a free-floating loop. The Doppler tracings will be used to measure fetal heart rate (FHR). All measurements will be performed during periods of fetal quiescence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Standard breakfast mealCrossover 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. |
| IUGR group | Other | Other: Standard breakfast mealWill only be examined one day. First ultrasound during fasting, and the second ultrasound 2 hours after a standard breakfast meal. |
Who may qualify
- Ages
- 16 to 58 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Control group: Pregnant caucasian women With singleton fetus, and without any disease which can influence placental function
Key exclusion criteria (2 listed)
- Food allergy
- use of medicine which can influence placental function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard breakfast mealThe 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. | Other | Control group, IUGR group |
Primary outcome
Doppler measures of fetal cerebral vascular resistance as mean cerebral artery pulsatility index (MCA-PI)
Time frame: 2-2,5 years
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).
Doppler measures of fetal liver blood flow (ml/min)
Time frame: 2-2,5 years
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).
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
Time frame: 1 year
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guttorm Haugen principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard breakfast meal in people with Fetal Growth Restriction, run by Guttorm Haugen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saba M Zahid (004792815971, smunee@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler measures of fetal cerebral vascular resistance as mean cerebral artery pulsatility index (MCA-PI) (time frame: 2-2,5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.