Intrauterine Growth RestrictionPhase 2NCT02696577
The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
A Phase 2 study testing Low dose aspirin and Omega 3 in people with Intrauterine Growth Restriction, run by Assiut University at 1 site in Egypt.
Trial summary
Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine growth restriction is diagnosed antenatal; however, some of these fetuses, especially if unscreened during pregnancy, may be detected only… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Low dose aspirin and Omega 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Feb 2016
- Phase
- Phase 2
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: from 20 - 35 years old.
- Pregnant from 30 week to 32 week gestation.
- Singleton pregnancy with asymmetrical intrauterine growth restriction .
- Normal uterine and umbilical Doppler indices at time of recruitment.
Who cannot join
- Multiple gestations.
- Hypertensive women.
- Premature rupture of membranes.
- Abnormal Doppler indices in the form of Doppler blood flow indices > 2 standard deviation , absent diastolic flow and lastly; reversed flow.
- Congenital fetal malformation.
- Pregnancy complicated by antepartum hemorrhage.
- Marked decrease in Amniotic fluid volume.
Trial locations and contacts
1 site in 1 country.
About this study
Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine growth restriction is diagnosed antenatal; however, some of these fetuses, especially if unscreened during pregnancy, may be detected only in the neonatal period. It is very important for obstetricians and perinatologists to identify growth restricted fetuses, because this fetal condition is associated with significant perinatal morbidity and mortality.
Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid end, which is considered the beginning of the chain, thus "alpha", and the methyl end, which is considered the "tail" of the chain, thus "omega." Omega3 improve fetal wellbeing by two mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and lactation normalizes intrauterine growth restriction induced changes in adipose deposition and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic function in intrauterine growth restriction
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Low dose aspirin, Omega 3
- 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.
Low dose aspirinDrug
Omega 3Drug
| Study group | Role | What they receive |
|---|---|---|
| Low dose aspirin | Active comparator | Received aspirin 81mg once daily for 6 weeks Receives: Drug: Low dose aspirin |
| Low dose aspirin plus omega 3 group | Active comparator | Received aspirin 81mg and omega 3 once daily for 6 weeks. Receives: Drug: Low dose aspirin; Drug: Omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated fetal weight (gm)
Measured: 1 year
Secondary outcomes (4)
The changes in Doppler blood flow indices in both uterine arteries
Measured: 1 year
The changes in Doppler blood flow indices in umbilical artery
Measured: 1 year
Fetal weight at the time of delivery (gm) ,
Measured: 1 year
Number of babies admitted to neonatal intensive care unit.
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 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696577
- Sponsor's protocol ID
- OIUGR
- Status last verified
- Mar 2016
- First submitted
- 28 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Ali MK, Amin ME, Amin AF, Abd El Aal DEM. Evaluation of the effectiveness of low-dose aspirin and omega 3 in treatment of asymmetrically intrauterine growth restriction: A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:231-235. doi: 10.1016/j.ejogrb.2017.01.002. Epub 2017 Jan 3.
PubMed 28068596
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT02696577
- Acronym / sponsor ID
- OIUGR
- Conditions
- Intrauterine Growth Restriction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Mar 2016 (estimated)
- 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 is a common and complex obstetric problem. Intrauterine growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine growth restriction is diagnosed antenatal; however, some of these fetuses, especially if unscreened during pregnancy, may be detected only in the neonatal period. It is very important for obstetricians and perinatologists to identify growth restricted fetuses, because this fetal condition is associated with significant perinatal morbidity and mortality.
Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid end, which is considered the beginning of the chain, thus "alpha", and the methyl end, which is considered the "tail" of the chain, thus "omega." Omega3 improve fetal wellbeing by two mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and lactation normalizes intrauterine growth restriction induced changes in adipose deposition and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic function in intrauterine growth restriction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose aspirin | Active comparator | Drug: Low dose aspirinReceived aspirin 81mg once daily for 6 weeks |
| Low dose aspirin plus omega 3 group | Active comparator | Drug: Low dose aspirin, Drug: Omega 3Received aspirin 81mg and omega 3 once daily for 6 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: from 20 - 35 years old.
- Pregnant from 30 week to 32 week gestation.
- Singleton pregnancy with asymmetrical intrauterine growth restriction .
- Normal uterine and umbilical Doppler indices at time of recruitment.
Key exclusion criteria (7 listed)
- Multiple gestations.
- Hypertensive women.
- Premature rupture of membranes.
- Abnormal Doppler indices in the form of Doppler blood flow indices > 2 standard deviation , absent diastolic flow and lastly; reversed flow.
- Congenital fetal malformation.
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 |
|---|---|---|
| Low dose aspirin | Drug | Low dose aspirin, Low dose aspirin plus omega 3 group |
| Omega 3 | Drug | Low dose aspirin plus omega 3 group |
Primary outcome
Estimated fetal weight (gm)
Time frame: 1 year
4 secondary outcomes
The changes in Doppler blood flow indices in both uterine arteries
Time frame: 1 year
The changes in Doppler blood flow indices in umbilical artery
Time frame: 1 year
Fetal weight at the time of delivery (gm) ,
Time frame: 1 year
Number of babies admitted to neonatal intensive care unit.
Time frame: 1 year
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 15 Mar 2016.
- Derived from this study: PubMed 28068596Ali MK, Amin ME, Amin AF, Abd El Aal DEM. Evaluation of the effectiveness of low-dose aspirin and omega 3 in treatment of asymmetrically intrauterine growth restriction: A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:231-235. doi: 10.1016/j.ejogrb.2017.01.002. Epub 2017 Jan 3.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose aspirin and Omega 3 in people with Intrauterine Growth Restriction, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 7 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 15 Mar 2016. 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 Egypt. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Estimated fetal weight (gm) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696577, which also lists 1 linked publication.
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 15 Mar 2016.