The Effects of Adjunctive Therapy With Vaginal Tablets Lactobacillus Acidophilus and a Low Dose Estriol (Gynoflor®) to Prolong Pregnancy Time in Preterm Labor, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- proportion of women remaining pregnant more than 7 days after initiation of tocolytic
研究概览
简要总结
The study aim to study The Adjunctive therapy with vaginal tablets containing Lactobacillus acidophilus KS400 and low-dose Estriol (Gynoflor®) in addition to standard tocolytic treatment administered once daily for 6 days starting the same day as tocolytic therapy, in pregnant women diagnosed with preterm labor at gestational age 24-33 weeks .Primary Outcome is the rate of pregnancy prolongation beyond 7 days after initiation of tocolytic therapy.
详细描述
Participants in the intervention group are pregnant women diagnosed with preterm labor between 24 and 33 weeks of gestation. They receive:
- Gynoflor® vaginal tablets (containing Lactobacillus acidophilus KS400 and 0.03 mg estriol)
- Dosage: 1 tablet inserted vaginally at bedtime for 6 consecutive days
- Start time: On the same day as starting standard tocolytic therapy (such as nifedipine, terbutaline, or magnesium sulfate)
- Purpose: To restore healthy vaginal flora, reduce risk of ascending infection, and potentially prolong pregnancy duration
The control group receives only standard tocolytic therapy, without Gynoflor®.
Outcomes (Detailed Description):
Primary Outcome:
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
- None
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
- •- Pregnant women diagnosed with preterm labor or threatened preterm labor, with a gestational age between 24 and 33 weeks, who are receiving tocolytic therapy.
排除标准
- •Age under 18 years or 35 years and older
- •Incomplete course of Gynoflor® (less than 6 days of use)
- •Presence of contraindications to tocolysis
- •Preterm premature rupture of membranes (PPROM)
- •Unable to be contacted for follow-up
- •History of allergy to probiotics or Gynoflor®
- •Multiple gestation
- •History of short cervix diagnosed between 16-24 weeks of gestation
- •History of previous preterm labor (PTL)
- •Pregnancy achieved via assisted reproductive technology (ART)
- •Presence of fetal anomaly
- •History of antepartum hemorrhage
- •Substance abuse, including cigarette smoking, alcohol, cocaine, or heroin use
- •Other causes of preterm labor such as uterine overdistension (e.g., polyhydramnios, multifetal gestation), uterine abnormalities (e.g., myoma uteri), or systemic infections, except vaginitis
研究组 & 干预措施
gynoflor group
干预措施: Gynoflor (Drug)
control group
结局指标
主要结局
proportion of women remaining pregnant more than 7 days after initiation of tocolytic
时间窗: within 7 days from the start of tocolytic
次要结局
未报告次要终点