Clinical Trial: Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

Brief Summary: To predict the effect of antioxidants in cases of oligohydramnios

Detailed Summary:

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
Sponsor: Woman's Health University Hospital, Egypt

Current Primary Outcome: 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.


Original Primary Outcome: improvement of amniotic fluid index [ Time Frame: two 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.


Current Secondary Outcome: pregnancy continuation till term,mode of delivery and perinatal outcomes [ Time Frame: 4 weeks ]

Treatment was started immediately and continued for 4 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 120. 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.


Original Secondary Outcome: pregnancy continuation till term,mode of delivery and perinatal outcomes [ 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 120. 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.


Information By: Woman's Health University Hospital, Egypt

Dates:
Date Received: November 15, 2013
Date Started: January 2014
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016