Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

Study Overview
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Brief Summary
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To predict the effect of antioxidants in cases of oligohydramnios

Detailed Description
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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).

Official Title
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Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

Conditions
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Oilgohydramnios

Intervention / Treatment
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* Drug: anti oxidant omega 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with gestational age between 30-34 weeks with: Oligohydramnios of unknown cause. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anti oxidant omega 3<br>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<br>* 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.<br>* Other names: omega 3 plus;|
| Placebo Comparator: placebo<br>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<br>* 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.<br>* Other names: omega 3 plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in Doppler resistance index | The resistance index is measured in the uterine and umbilical artery by ultrasound | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes