Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

NCT01990690 | Completed Phase 4 DMC

• 1 other identifier: aouoh
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

To predict the effect of antioxidants in cases of oligohydramnios

Conditions

Oilgohydramnios

Keywords

oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The changes in Doppler resistance index

  4 weeks

Study Arms (2)

anti oxidant omega 3

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: omega 3 plus

anti oxidant omega 3; placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with gestational age between 30-34 weeks with:
• Oligohydramnios of unknown cause.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Oligohydramnios

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Alaa M Ismail, M D

  Women's Health Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor ob/gyn

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

EG (1)