Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

Oilgohydramnios Clinical Trial

— ao&uoh  

Official title:

Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990690
• Other study ID #: aouoh
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2020
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To predict the effect of antioxidants in cases of oligohydramnios

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Oilgohydramnios
• Oligohydramnios

Intervention

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.

Locations

Country	Name	City	State
Egypt	Women's Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The changes in Doppler resistance index	The resistance index is measured in the uterine and umbilical artery by ultrasound	4 weeks