Small for Gestational Age at DeliveryNCT04161989
Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses
A study testing omega-3 fatty acids and vaginal progesterone in people with Small for Gestational Age at Delivery, run by Assiut University at 1 site in Egypt.
Trial summary
Small for gestational age refers to an infant born with a birth weight less than the 10th centile. Severe small for gestational age refers to an infant born with a birth weight less than the 3rd centile. Constitutionally small fetuses are fetuses whose growth at all gestational ages has been low but otherwise healthy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Small for Gestational Age at Delivery
- What is being tested?
- omega-3 fatty acids and vaginal progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Jun 2022
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 20-35 years.
- Pregnant women from 28 to 30 weeks gestation.
- Women with small for gestational age fetus. It refers to an estimated fetal weight or abdominal circumference <10th centile with no pathology is present.
- Women with normal resistant index in uterine arteries at the time of recruitment.
- Women with normal resistant index in umbilical arteries at the time of recruitment.
Who cannot join
- Women with estimated fetal weight below the 5th or 3rd percentile.
- Women with any major risk factors for intrauterine growth restriction.
- Women with multiple pregnancies.
- Women with low amniotic fluid volume or premature pre-labor rupture of membranes.
- Women with antepartum hemorrhage or fetal congenital anomalies.
- Women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment.
- Women with any contraindications for progesterone or omega 3.
- Women who refused to participate in our study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Omega 3 and Vaginal Progesterone on Birth Weight and Doppler Velocimetry of Constitutionally Small for Gestational Age Fetuses.
Small for gestational age refers to an infant born with a birth weight less than the 10th centile. Severe small for gestational age refers to an infant born with a birth weight less than the 3rd centile. Constitutionally small fetuses are fetuses whose growth at all gestational ages has been low but otherwise healthy. Those babies have a great risk for perinatal morbidity and mortality. Many causes are responsible for the development of Severe small for gestational age, however; in a few cases, the cause could not be detected. In contrast to pathologic intrauterine growth restriction, the constitutionally small fetuses have normal umbilical and middle cerebral artery Doppler velocimetry and normal amniotic fluid volume. In this circumstance, continued biophysical testing and delivery at 38-39 weeks is reasonable. Low birth weight fetuses comprise both preterm births and SGA. They are at a higher risk of adverse birth outcomes. So the trials to increase the blood flow to the uterus and/or the fetus may improve the neonatal outcomes. There are many lines of treatment that have been emerged now for the treatment of small for gestational age fetuses like maternal rest and oxygenation, aspirin therapy, supplementation of zinc, and fish oil. However; all mentioned lines of treatment lack evidence of effectiveness in literature. Omega-3 fatty acids as antioxidants inhibit the free radicals released during pregnancy which are responsible for vasoconstriction; so vasodilatation will occur. This leads to increase blood flow to the uterus and placenta which improves pregnancy outcomes. Progesterone is a smooth muscle relaxant and has a vasodilator effect on the blood vessels. It causes endothelium- relaxation of human placental arteries and veins. This relaxation is significant for maintaining low flow impedance and satisfactory blood flow in the placental circulation. DeFranco et al observed that vaginal progesterone is associated with vascular relaxation and increased uterine blood flow. But, he did not observe this vascular effect in women receiving systemic progesterone. So from the above evidence; there is a need to study the effect of omega 3 and progesterone on pregnant women whose pregnancy is complicated with constitutionally small for gestational age fetuses in trial to find a new line of treatment of this problem.
- Conditions
- Small for Gestational Age at Delivery
- Being tested
- omega-3 fatty acids, vaginal progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidsDrug
. The Omega 3 plus capsule contains 1000 mg Fish Oil (contains Eicosapentaenoic acid 13% \& Docosahexaenoic acid 9%) plus 100 mg Wheat Germ Oil (Linoleic acid 52- 59%) as a natural source of Vitamin E.
vaginal progesteroneDrug
Prontogest 400 mg vaginal suppository contains progesterone 400 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group I (omega-3 fatty acids group) | Other | received omega 3 (Omega 3 plus, SEDICO, Egypt); once daily from 28-30 weeks till delivery. The omega 3 plus capsule contains 1000 mg Fish Oil plus 100 mg Wheat Germ Oil is a natural source of Vitamin E. Receives: Drug: omega-3 fatty acids |
| Group II (vaginal progesterone plus omega-3 group) | Other | received vaginal progesterone (Prontogest 400 mg vaginal suppository, Marcyrl Pharmaceutical Industries, Egypt) and omega 3 once daily from 28-30 weeks till delivery. Receives: Drug: omega-3 fatty acids; Drug: vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean birth weight (gram)
Measured: 6 weeks
Secondary outcomes (4)
Estimated fetal weight (gram)
Measured: 6 weeks
Time of delivery (weeks)
Measured: 6 weeks
Doppler indices in the umbilical artery
Measured: 6 weeks
Doppler indices in the uterine artery
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 May 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational Age at DeliveryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT04161989
- Sponsor's protocol ID
- SGA-VP
- Status last verified
- Sep 2022
- First submitted
- 11 Nov 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega 3 and Vaginal Progesterone on Birth Weight and Doppler Velocimetry of Constitutionally Small for Gestational Age Fetuses.
- ClinicalTrials.gov ID
- NCT04161989
- Acronym / sponsor ID
- SGA-VP
- Conditions
- Small for Gestational Age at Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Nov 2019 (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.
Small for gestational age refers to an infant born with a birth weight less than the 10th centile. Severe small for gestational age refers to an infant born with a birth weight less than the 3rd centile. Constitutionally small fetuses are fetuses whose growth at all gestational ages has been low but otherwise healthy. Those babies have a great risk for perinatal morbidity and mortality. Many causes are responsible for the development of Severe small for gestational age, however; in a few cases, the cause could not be detected. In contrast to pathologic intrauterine growth restriction, the constitutionally small fetuses have normal umbilical and middle cerebral artery Doppler velocimetry and normal amniotic fluid volume. In this circumstance, continued biophysical testing and delivery at 38-39 weeks is reasonable. Low birth weight fetuses comprise both preterm births and SGA. They are at a higher risk of adverse birth outcomes. So the trials to increase the blood flow to the uterus and/or the fetus may improve the neonatal outcomes. There are many lines of treatment that have been emerged now for the treatment of small for gestational age fetuses like maternal rest and oxygenation, aspirin therapy, supplementation of zinc, and fish oil. However; all mentioned lines of treatment lack evidence of effectiveness in literature. Omega-3 fatty acids as antioxidants inhibit the free radicals released during pregnancy which are responsible for vasoconstriction; so vasodilatation will occur. This leads to increase blood flow to the uterus and placenta which improves pregnancy outcomes. Progesterone is a smooth muscle relaxant and has a vasodilator effect on the blood vessels. It causes endothelium- relaxation of human placental arteries and veins. This relaxation is significant for maintaining low flow impedance and satisfactory blood flow in the placental circulation. DeFranco et al observed that vaginal progesterone is associated with vascular relaxation and increased uterine blood flow. But, he did not observe this vascular effect in women receiving systemic progesterone. So from the above evidence; there is a need to study the effect of omega 3 and progesterone on pregnant women whose pregnancy is complicated with constitutionally small for gestational age fetuses in trial to find a new line of treatment of this problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (omega-3 fatty acids group) | Other | Drug: omega-3 fatty acidsreceived omega 3 (Omega 3 plus, SEDICO, Egypt); once daily from 28-30 weeks till delivery. The omega 3 plus capsule contains 1000 mg Fish Oil plus 100 mg Wheat Germ Oil is a natural source of Vitamin E. |
| Group II (vaginal progesterone plus omega-3 group) | Other | Drug: omega-3 fatty acids, Drug: vaginal progesteronereceived vaginal progesterone (Prontogest 400 mg vaginal suppository, Marcyrl Pharmaceutical Industries, Egypt) and omega 3 once daily from 28-30 weeks till delivery. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women aged 20-35 years.
- Pregnant women from 28 to 30 weeks gestation.
- Women with small for gestational age fetus. It refers to an estimated fetal weight or abdominal circumference <10th centile with no pathology is present.
- Women with normal resistant index in uterine arteries at the time of recruitment.
- Women with normal resistant index in umbilical arteries at the time of recruitment.
Key exclusion criteria (8 listed)
- Women with estimated fetal weight below the 5th or 3rd percentile.
- Women with any major risk factors for intrauterine growth restriction.
- Women with multiple pregnancies.
- Women with low amniotic fluid volume or premature pre-labor rupture of membranes.
- Women with antepartum hemorrhage or fetal congenital anomalies.
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 |
|---|---|---|
| omega-3 fatty acids. The Omega 3 plus capsule contains 1000 mg Fish Oil (contains Eicosapentaenoic acid 13% \& Docosahexaenoic acid 9%) plus 100 mg Wheat Germ Oil (Linoleic acid 52- 59%) as a natural source of Vitamin E. | Drug | Group I (omega-3 fatty acids group), Group II (vaginal progesterone plus omega-3 group) |
| vaginal progesteroneProntogest 400 mg vaginal suppository contains progesterone 400 mg. | Drug | Group II (vaginal progesterone plus omega-3 group) |
Primary outcome
The difference in mean birth weight (gram)
Time frame: 6 weeks
4 secondary outcomes
Estimated fetal weight (gram)
Time frame: 6 weeks
Time of delivery (weeks)
Time frame: 6 weeks
Doppler indices in the umbilical artery
Time frame: 6 weeks
Doppler indices in the uterine artery
Time frame: 6 weeks
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 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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 study testing omega-3 fatty acids and vaginal progesterone in people with Small for Gestational Age at Delivery, 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 5 inclusion and 8 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 21 Sep 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 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.
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 difference in mean birth weight (gram) (time frame: 6 weeks). 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 21 Sep 2022.