Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Perinatal morti-morbidity
研究概览
简要总结
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
详细描述
Preterm premature rupture of membranes (PPROM) complicates 3% of pregnancies and accounts for one-third of preterm births. It is a leading cause of neonatal mortality and morbidity and increases the risk of maternal infectious morbidity. In cases of early PPROM (22 to 33 completed weeks' gestation), expectant management is recommended in the absence of labor, chorioamnionitis or fetal distress. Antenatal steroids and antibiotics administration are recommended by international guidelines. However, there is no recommendation regarding tocolysis administration in the setting of PPROM. In theory, reducing uterine contractility should delay delivery and reduce risks of prematurity and neonatal adverse consequences. Likewise, a prolongation of gestation may allow administering a corticosteroids complete course that is associated with a two-fold reduction of morbidity and mortality. However, tocolysis may prolong fetal exposure to inflammation and be associated with higher risk of materno-fetal infection, potentially associated with neonatal death or long-term sequelae, including cerebral palsy.
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
- •Singleton gestation
- •Fetus alive at the time of randomization (reassuring fetal heart monitoring)
- •18 years of age or older
- •French speaking
- •Affiliated to social security regime or an equivalent system
- •Informed consent and signed
排除标准
- •PPROM ≥ 24 hours before diagnosis
- •Ongoing tocolytic treatment at the time of PPROM
- •Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
- •Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
- •Cervical dilation > 5 cm
- •Iatrogenic rupture caused by amniocentesis or trophoblast biopsy
- •Major fetal anomaly
- •Maternal allergy or contra-indication to Nifedipine or placebo drug components*:
- •Myocardial infarction
- •Unstable angina pectoris
- •Hepatic insufficiency
- •Cardiovascular shock
- •Beta blockers
- •placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose
- •Coadministration of diltiazem or rifampicin
- •Hypotension (systolic pressure < 90 mmHg)
- •Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)
研究组 & 干预措施
Nifedipine
干预措施: Nifedipine (Drug)
Placebo
干预措施: Placebo of Nifedipine (Drug)
结局指标
主要结局
Perinatal morti-morbidity
时间窗: Up to discharge from hospital, with a maximum of 24 weeks after birth.
Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation ≥ 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).
次要结局
- Prolongation of gestation(Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy))
- Neonatal mortality(From birth to discharge from hospital, with a maximum of 24 weeks after birth.)
- Frequency of Gross motor impairment among children alive at 2 years of corrected age(At 22-26 months of corrected age)
- Maternal morbidity(At delivery)
- Fetal mortality(Up to delivery so up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy))
- Neonatal severe morbidity(From birth to discharge from hospital, with a maximum of 24 weeks after birth.)
- Frequency of Neurosensory impairment among children alive at 2 years of corrected age(At 22-26 months of corrected age)
- Neonatal morbidity(From Day 3 after birth to discharge from hospital, with a maximum of 24 weeks after birth.)
- Vital status(At 22-26 months of corrected age)