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Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial (ao&uoh)

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ClinicalTrials.gov Identifier: NCT01990690
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Brief Summary:
To predict the effect of antioxidants in cases of oligohydramnios

Condition or disease Intervention/treatment Phase
Oilgohydramnios Drug: anti oxidant omega 3 Phase 4

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:

  1. To study the effect of antioxidants in cases of oligohydramnios.
  2. To study the effect of antioxidants on mode of delivery and neonatal outcome.
  3. 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:

  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.

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: anti oxidant omega 3
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

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.

Other Name: omega 3 plus

Placebo Comparator: placebo

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.

Other Name: omega 3 plus




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. pregnancy continuation till term,mode of delivery and perinatal outcomes [ Time Frame: 4 weeks ]
    Treatment was started immediately and continued for 4 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 120. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990690


Locations
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Egypt
Women's Health Hospital
Assiut, Egypt
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Alaa M Ismail, M D Women's Health Hospital

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Responsible Party: alaa eldeen mahmoud ismail, Assistant professor ob/gyn, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01990690    
Other Study ID Numbers: aouoh
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt:
oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes
Additional relevant MeSH terms:
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Oligohydramnios
Pregnancy Complications
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs