OilgohydramniosPhase 4ao&uohNCT01990690
Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
A Phase 4 study testing anti oxidant omega 3 in people with Oilgohydramnios, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
To predict the effect of antioxidants in cases of oligohydramnios Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oilgohydramnios
- What is being tested?
- anti oxidant omega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Aug 2015
- Phase
- Phase 4
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with gestational age between 30-34 weeks with:
- Oligohydramnios of unknown cause.
Who cannot join
- 1- Premature rupture of membranes. 2- Oligohydramnios in postdates pregnancy (>41 weeks). 3- Fetal anomalies. 4- IUGR. 5- Patients using non steroidal anti-inflammatory drugs. 6 - Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).
Trial locations and contacts
1 site in 1 country.
About this study
To predict the effect of antioxidants in cases of oligohydramnios
Read the detailed description
Type of study:
This is a prospective randomized controlled study that was done in department of obstetrics and gynecology of Assiut University Hospital.
Aim of the work:
- To study the effect of antioxidants in cases of oligohydramnios.
- To study the effect of antioxidants on mode of delivery and neonatal outcome.
- To commence special recommendations from the study about the use of antioxidants in cases of oligohydramnios of unknown cause and cases of oligohydramnios associated with pregnancy induced hypertension.
Inclusion criteria:
Patients with gestational age between 30-34 weeks with:
- Oligohydramnios of unknown cause.
- Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).
Exclusion criteria:
- Premature rupture of membranes.
- Oligohydramnios in postdates pregnancy (>41 weeks).
- Fetal anomalies.
- IUGR.
- Patients using non steroidal anti-inflammatory drugs.
Assessment of the patients:
The target population was assessed to find the participating women suitable for the study, this assessment was done to verify inclusion criteria and to exclude any women has any of the exclusion criteria.
Ultrasongraphic evaluation:
Ultrasongraphy was done for estimation of amniotic fluid index by measuring the vertical diameter of the pockets of amniotic fluid in four sections of the uterus and add them together. This gives them a number known as amniotic fluid index (AFI). If the AFI is less than 5 centimeters, the pregnant woman has oligohydramnios
Composition of omega-3 plus:
Soft gelatineous capsule (Sedico medical company) each capsule contains:
- Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids.
- Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids).
- Conditions
- Oilgohydramnios
- Being tested
- anti oxidant omega 3
- Keywords
- oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti oxidant omega 3Drug
Also called omega 3 plus
Soft gelatineous capsule (Sedico medical company) each capsule contains:
- Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids.
- Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids).
Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| anti oxidant omega 3 | Active comparator | The patients were randomized to receive either a daily dose of omega-3 plus as antioxidant once daily for two weeks or a daily placebo then stored in envelopes numbered from 1 to 140 Receives: Drug: anti oxidant omega 3 |
| placebo | Placebo comparator | Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks.
Group 2 was given a placebo once daily for two weeks. Receives: Drug: anti oxidant omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of amniotic fluid index
Treatment was started immediately and continued for two weeks. The patients were randomized to receive either a daily dose of omega-3 plus as antioxidant once daily for two weeks or a daily placebo then stored in envelopes numbered from 1 to 140. The envelopes were numbered and randomized according to computer-generated randomization tables to ensure an equal number of patients in each arm. Throughout the trial, access to the randomization code was available only to the pharmacist who manufactured the placebo and packed the envelopes and was not available to any of the treating physicians or patients.
Measured: 4 weeks
Secondary outcomes (1)
The changes in Doppler resistance index
The resistance index is measured in the uterine and umbilical artery by ultrasound
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OilgohydramniosStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
- Investigators
- Alaa M Ismail, M D, Principal investigator, Women's Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990690
- Sponsor's protocol ID
- aouoh
- Acronym
- ao&uoh
- Status last verified
- Aug 2020
- First submitted
- 15 Nov 2013
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
- ClinicalTrials.gov ID
- NCT01990690
- Acronym / sponsor ID
- ao&uoh / aouoh
- Conditions
- Oilgohydramnios
- Keywords
- oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Nov 2013 (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.
To predict the effect of antioxidants in cases of oligohydramnios
Detailed description
Type of study:
This is a prospective randomized controlled study that was done in department of obstetrics and gynecology of Assiut University Hospital.
Aim of the work:
- To study the effect of antioxidants in cases of oligohydramnios.
- To study the effect of antioxidants on mode of delivery and neonatal outcome.
- To commence special recommendations from the study about the use of antioxidants in cases of oligohydramnios of unknown cause and cases of oligohydramnios associated with pregnancy induced hypertension.
Inclusion criteria:
Patients with gestational age between 30-34 weeks with:
- Oligohydramnios of unknown cause.
- Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).
Exclusion criteria:
- Premature rupture of membranes.
- Oligohydramnios in postdates pregnancy (>41 weeks).
- Fetal anomalies.
- IUGR.
- Patients using non steroidal anti-inflammatory drugs.
Assessment of the patients:
The target population was assessed to find the participating women suitable for the study, this assessment was done to verify inclusion criteria and to exclude any women has any of the exclusion criteria.
Ultrasongraphic evaluation:
Ultrasongraphy was done for estimation of amniotic fluid index by measuring the vertical diameter of the pockets of amniotic fluid in four sections of the uterus and add them together. This gives them a number known as amniotic fluid index (AFI). If the AFI is less than 5 centimeters, the pregnant woman has oligohydramnios
Composition of omega-3 plus:
Soft gelatineous capsule (Sedico medical company) each capsule contains:
- Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids.
- Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti oxidant omega 3 | Active comparator | Drug: anti oxidant omega 3The patients were randomized to receive either a daily dose of omega-3 plus as antioxidant once daily for two weeks or a daily placebo then stored in envelopes numbered from 1 to 140 |
| placebo | Placebo comparator | Drug: anti oxidant omega 3Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks. Group 2 was given a placebo once daily for two weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with gestational age between 30-34 weeks with:
- Oligohydramnios of unknown cause.
Key exclusion criteria (1 listed)
- 1- Premature rupture of membranes. 2- Oligohydramnios in postdates pregnancy (>41 weeks). 3- Fetal anomalies. 4- IUGR. 5- Patients using non steroidal anti-inflammatory drugs. 6 - Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).
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 |
|---|---|---|
| anti oxidant omega 3Also: omega 3 plusSoft gelatineous capsule (Sedico medical company) each capsule contains: * Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids. * Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids). Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks. | Drug | anti oxidant omega 3, placebo |
Primary outcome
improvement of amniotic fluid index
Time frame: 4 weeks
Treatment was started immediately and continued for two weeks. The patients were randomized to receive either a daily dose of omega-3 plus as antioxidant once daily for two weeks or a daily placebo then stored in envelopes numbered from 1 to 140. The envelopes were numbered and randomized according to computer-generated randomization tables to ensure an equal number of patients in each arm. Throughout the trial, access to the randomization code was available only to the pharmacist who manufactured the placebo and packed the envelopes and was not available to any of the treating physicians or patients.
1 secondary outcome
The changes in Doppler resistance index
Time frame: 4 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 18 Aug 2020.
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.
Alaa M Ismail, M D principal investigator
Women's Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anti oxidant omega 3 in people with Oilgohydramnios, run by Woman's Health University Hospital, Egypt 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 2 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 18 Aug 2020. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
improvement of amniotic fluid index (time frame: 4 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 18 Aug 2020.