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Completed

NCT Number: NCT01990690

Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

To predict the effect of antioxidants in cases of oligohydramnios

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women's Health Hospital

Asyut, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

anti oxidant omega 3

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.

Other names: omega 3 plus

Primary outcomes

  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 outcomes

  1. The changes in Doppler resistance index

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Acronym: ao&uoh

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2013
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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