Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

NCT ID: NCT01990690

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

Brief Summary

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:

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).

Conditions

Oilgohydramnios

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

anti oxidant omega 3

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

anti oxidant omega 3

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

omega 3 plus

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

alaa eldeen mahmoud ismail

Assistant professor ob/gyn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa M Ismail, M D

Role: PRINCIPAL_INVESTIGATOR

Women's Health Hospital

Locations

Women's Health Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

aouoh

Identifier Type: -

Identifier Source: org_study_id