Intrauterine Growth RestrictionNCT05142644
IUGR; Cause and Relationship
An observational study of Intrauterine Growth Restriction, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Intrauterine growth restriction (IUGR) is a pregnancy complication in about 3-5% of all pregnancies in Sweden. IUGR fetuses are at high risk of morbidity and death. The method used in Sweden to detect IUGR is repeated measurements of pregnant women's symphysis-fundus measure (SF measure). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 80,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 30 Oct 2021
- Phase
- Observational
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: All pregnant women in Stockholm during 2014-2017
Who may be able to join
- All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other serious structural abnormalities, will be included in the project.
Who cannot join
- Pregnancies with known chromosomal abnormalities or other serious structural abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra Uterine Growth Retardation;Causes and Relationship
Intrauterine growth restriction (IUGR) is a pregnancy complication in about 3-5% of all pregnancies in Sweden. IUGR fetuses are at high risk of morbidity and death. The method used in Sweden to detect IUGR is repeated measurements of pregnant women's symphysis-fundus measure (SF measure).
Weight estimation with ultrasound is performed only on indication; stagnant or deplaning SF dimensions or in the event of complications. Only high-risk pregnancies have repeated growth checks during pregnancy from the beginning.
Read more
There are potential benefits to detecting IUGR fetuses during pregnancy. Still, the effect is questioned. A meta-analysis of randomized studies could not benefit from a routine ultrasound in the third trimester.
The scientific purpose of this work is to evaluate the benefits of early detection and care of SGA (small for gestational age)/IUGR (growth-inhibited) fetuses and, if possible, to increase knowledge about this patient group. The hope is that this will lead to a better opportunity to personalize both preventive care and treatment of these women and children.
Read the detailed description
Design: Register-based cohort study. Population: All pregnancies in Stockholm from 2014 to 2017 A Composite outcome for the study is constructed and consists of at least one of the following outcomes
- HIE (hypoxic-ischemic encephalopathy)2-3 (neonatal convulsions in the fetus after childbirth),
- Intracranial hemorrhage,
- Apgar score < 4 at 5 minutes,
- Arterial umbilical cord pH (potential of hydrogen) < 7.10,
- Intrauterine fetal death, 6)intrapartal death.
Inclusion: All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other structural abnormalities, will be included in the project.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- ultrasound
- Keywords
- IUGR, SGA
- 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.
ultrasoundProcedure or surgery
An extra ultrasound performed during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Early / growth restriction | Intrauterine growth restriction with onset before 32 weeks of gestation Receives: Procedure: ultrasound | |
| Late growth restriction | Intrauterine growth restriction with onset after 32 weeks of gestation Receives: Procedure: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)
Will the perinatal outcome at delivery( be measured as a low Apgar score at 5 minutes or an affected acid-base status in cord blood) be improved if IUGR(intrauterine growth restriction) is identified before labor
Measured: 2014-2017
Secondary outcomes (1)
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2)
Will the outcome changes persist if the group with IUGR will be divided into early- or late-diagnosed IUGR (before and after week 32 of pregnancy)?
Measured: January 1th 2014- december 31th 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Jan 2020
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
- Investigators
- Eva Wiberg-Itzel, PhD, Principal investigator, Karolinska Institute Sodersjukhuset Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142644
- Sponsor's protocol ID
- Early or late IUGR
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Uterine Growth Retardation;Causes and Relationship
- ClinicalTrials.gov ID
- NCT05142644
- Acronym / sponsor ID
- Early or late IUGR
- Conditions
- Intrauterine Growth Restriction
- Keywords
- IUGR, SGA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 2 Dec 2021 (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.
Intrauterine growth restriction (IUGR) is a pregnancy complication in about 3-5% of all pregnancies in Sweden. IUGR fetuses are at high risk of morbidity and death. The method used in Sweden to detect IUGR is repeated measurements of pregnant women's symphysis-fundus measure (SF measure).
Weight estimation with ultrasound is performed only on indication; stagnant or deplaning SF dimensions or in the event of complications. Only high-risk pregnancies have repeated growth checks during pregnancy from the beginning.
There are potential benefits to detecting IUGR fetuses during pregnancy. Still, the effect is questioned. A meta-analysis of randomized studies could not benefit from a routine ultrasound in the third trimester.
The scientific purpose of this work is to evaluate the benefits of early detection and care of SGA (small for gestational age)/IUGR (growth-inhibited) fetuses and, if possible, to increase knowledge about this patient group. The hope is that this will lead to a better opportunity to personalize both preventive care and treatment of these women and children.
Detailed description
Design: Register-based cohort study. Population: All pregnancies in Stockholm from 2014 to 2017 A Composite outcome for the study is constructed and consists of at least one of the following outcomes
- HIE (hypoxic-ischemic encephalopathy)2-3 (neonatal convulsions in the fetus after childbirth),
- Intracranial hemorrhage,
- Apgar score < 4 at 5 minutes,
- Arterial umbilical cord pH (potential of hydrogen) < 7.10,
- Intrauterine fetal death, 6)intrapartal death.
Inclusion: All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other structural abnormalities, will be included in the project.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early / growth restriction | – | Procedure: ultrasoundIntrauterine growth restriction with onset before 32 weeks of gestation |
| Late growth restriction | – | Procedure: ultrasoundIntrauterine growth restriction with onset after 32 weeks of gestation |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All pregnant women in Stockholm during 2014-2017
Key inclusion criteria (1 listed)
- All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other serious structural abnormalities, will be included in the project.
Key exclusion criteria (1 listed)
- Pregnancies with known chromosomal abnormalities or other serious structural abnormalities
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 |
|---|---|---|
| ultrasoundAn extra ultrasound performed during pregnancy | Procedure or surgery | Early / growth restriction, Late growth restriction |
Primary outcome
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)
Time frame: 2014-2017
Will the perinatal outcome at delivery( be measured as a low Apgar score at 5 minutes or an affected acid-base status in cord blood) be improved if IUGR(intrauterine growth restriction) is identified before labor
1 secondary outcome
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2)
Time frame: January 1th 2014- december 31th 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Eva Wiberg-Itzel, PhD principal investigator
Karolinska Institute Sodersjukhuset Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Karolinska Institutet at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 4 Jan 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor) (time frame: 2014-2017). 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 4 Jan 2022.