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

To predict the effect of antioxidants in cases of oligohydramnios

Study Overview

• Status: Completed
• Conditions: Oilgohydramnios
• Intervention / Treatment: Drug: anti oxidant omega 3

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).

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Women's health hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: omega 3 plus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Woman's Health University Hospital, Egypt
• Investigators: Principal Investigator: Alaa M Ismail, M D, Women's health hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (ESTIMATE): November 21, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes
• Additional Relevant MeSH Terms: Pregnancy Complications; Oligohydramnios; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: aouoh

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No