A Phase 4 interventional study of anti oxidant omega 3 in Oilgohydramnios, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by Woman's Health University Hospital, Egypt · Phase 4, Interventional, and Treatment
To predict the effect of antioxidants in cases of oligohydramnios
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:
Inclusion criteria:
Patients with gestational age between 30-34 weeks with:
Exclusion criteria:
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:
25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.
This study's enrollment of 202 is above the median of 91 across 16 interventional studies indexed under Oligohydramnios.
Browse Oligohydramnios studies →Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
Drug: anti oxidant omega 3
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.
Drug: anti oxidant omega 3
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.
Also known as: omega 3 plus
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.
Time frame: 4 weeks
The changes in Doppler resistance index
The resistance index is measured in the uterine and umbilical artery by ultrasound
Time frame: 4 weeks
The record gives a start of Jan 2015, a primary completion of Jul 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Woman's Health University Hospital, Egypt