Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- improvement of amniotic fluid index
研究概览
简要总结
To predict the effect of antioxidants in cases of oligohydramnios
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with gestational age between 30-34 weeks with:
- •Oligohydramnios of unknown cause.
排除标准
- •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).
研究组 & 干预措施
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
干预措施: anti oxidant omega 3 (Drug)
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.
干预措施: anti oxidant omega 3 (Drug)
结局指标
主要结局
improvement of amniotic fluid index
时间窗: 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.
次要结局
- The changes in Doppler resistance index(4 weeks)
研究者
alaa eldeen mahmoud ismail
Assistant professor ob/gyn
Woman's Health University Hospital, Egypt