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

Primary Purpose

Oilgohydramnios

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
anti oxidant omega 3
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oilgohydramnios focused on measuring oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Women's Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

anti oxidant omega 3

placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The changes in Doppler resistance index
The resistance index is measured in the uterine and umbilical artery by ultrasound

Full Information

First Posted
November 15, 2013
Last Updated
August 13, 2020
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT01990690
Brief Title
Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
Acronym
ao&uoh
Official Title
Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oilgohydramnios
Keywords
oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anti oxidant omega 3
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
anti oxidant omega 3
Other Intervention Name(s)
omega 3 plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
improvement of amniotic fluid index
Description
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
Secondary Outcome Measure Information:
Title
The changes in Doppler resistance index
Description
The resistance index is measured in the uterine and umbilical artery by ultrasound
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Ismail, M D
Organizational Affiliation
Women's Health Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Hospital
City
Assiut
Country
Egypt

12. IPD Sharing Statement

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Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

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