JPRN-jRCTs031210631招募中2 期
Protective and adverse effects of azithromycin (AZM) on pregnant women with preterm premature rupture of the membranes (pPROM) occurring at <28 weeks of gestation on the development of bronchopulmonary dysplasia in the neonates: 2nd phase, multicenter, nonblinded, randomized controlled trials - PPROM-AZM Study
Ohkuchi Akihide0 个研究点目标入组 100 人开始时间: 2022年2月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •(1) Pregnant woman who gave consent on the participation for the current trial.
- •(2) Pregnant woman in whom the age at receiving informed consent is equal to or over than 18 years old.
- •(3) Pregnant woman with a singleton pregnancy who developed
- •preterm premature rupture of the membranes (pPROM) occurring at 22 weeks 0 days - 27 weeks 6 days.
排除标准
- •(1) Pregnant woman with placenta previa.
- •(2) Pregnant woman with trachelectomy; However, pregnant woman with cervical incision should not be excluded, because such subject is at high risk for the occurrence of pPROM.
- •(3) Pregnant woman with hypertensive disorders of pregnancy (HDP); However, pregnant woman with chronic hypertension should not be excluded.
- •(4) Pregnant woman with a fetus who shows either AEDV or REDV before the onset of pPROM.
- •(5) Pregnant woman with any malignant tumors for whom the attending physicians consider the termination of pregnancy at very early pregnancy period.
- •(6) Pregnant woman with pPROM for whom the attending physicians consider the imminent termination of pregnancy at or soon after the onset of pPROM.
- •(7) Pregnant woman with pPROM who has had any diseases or symptoms by which the attending physicians consider the imminent termination of pregnancy at or soon after the onset of pPROM.
- •(8) Pregnant woman with the administration of AZM due to chlamydia infection within 2 weeks before the onset of pPROM.
- •(9) Pregnant woman with any kinds of antibiotics rather than either penicillin or cephem antibiotics for two weeks before the onset of pPROM.
- •(10) Pregnant woman who has been administered antibiotics rather than either ABPC or ABPC/SBT, from the onset of pPROM to the time obtaining consent; However, the following pregnant woman should not be excluded: when the administration of antibiotics rather than either ABPC or ABPC/SBT (excluding any kinds of macrolide antibiotics) were performed one day before the time of obtaining consent or earlier and the administration period of them were within 3 days.
- •(11) Pregnant woman with the administration of any kinds of macrolide antibiotics, from the onset of pPROM to the time obtaining consent.
- •(12) Pregnant woman with allergy for either penicillin or macrolide antibiotics.
- •(13) Pregnant woman complicated with infectious mononucleosis.
- •(14) Pregnant woman with a fetus with either chromosomal abnormalities or suspected severe multi-congenital anomaly syndrome.
- •(15) Pregnant woman with creatinine level of >=1.1 mg/dL at screening test just after obtaining consent.
- •(16) Pregnant woman complicated with QT syndrome.
- •(17) Pregnant woman with any types of psychological disorders for whom the attending physicians think that the patients should not be participated in the current trial.
- •(18) Pregnant woman for whom the attending physicians think that the patients should not be participated in the current trial, because there are some reasons which will disturb the achievement of the trial.
研究者
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