A Randomized controlled trial to compare the effectiveness of Metformin in prolonging period of gestation in Pre-eclampsia without severe features to standard treatment
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
研究概览
简要总结
This is a single centre, open- label, parallel- group, block- randomized, superiority randomized controlled trial with individual participant randomization.
Phase iv trial evaluating metformin as an adjunct to standard treatment in women wih pre-eclampsia without severe features beyond 28 weeks of gestation,
Patients with mild pre-eclampsia who will meet the inclusion criteria and will consent to the study will be recruited as cases, and consenting pre-eclamptic individuals will be recruited as controls. A study number will be assigned to each recruited subject. The subjects will be randomly divided and will be allotted according to computer randomized table of Block 4. Gestational age will be estimated from the reliable last menstrual period or early obstetric ultrasound scan.
· Patients will be classified into two groups.
GROUP 1: 500mg of oral extended release metformin daily in three times a day until delivery along with standardised treatment protocol
GROUP 2: Standardised treatment protocol (Antihypertensives: Tab. Labetalol 100mg or Tab.Depin R)
Patients will be allotted according to the computer randomized table of Block 4 with allocation concealement by sequentially numbered, opaque, sealed envelopes.
The primary outcome is duration of pregnancy prolongation in days from randomization to delivery. Secondary outcomes include selected neonatal outcomes and maternal adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with age more than or equal to 18 years of age.
- •Women diagnosed with pre-eclampsia without severe features with period of gestation more than 28 weeks.
排除标准
- •Multiple pregnancies
- •Women with chronic hypertension, gestational hypertension.
- •Women with gestational diabetes mellitus.
- •Women with contraindications to metformin (Renal dysfunction, hypersensitivity to metformin, Acute or chronic metabolic acidosis, Impaired hepatic function)
- •Women with pre-existing conditions that could interfere with the study outcomes (e.g., severe renal impairment, liver disease).
- •Women who are already on medications that could affect the study outcomes (glyburide, furosemide or cationic drugs).
研究者
Dr Shinde Manali Madhukar
Shri B.M Patil Medical college Hospital and Research centre