2023-509421-41-03招募中3 期
AUTOP 2 : Screen-and-treat strategy for vaginal flora abnormalities by molecular biology in pregnant women at high risk of preterm birth: A Multicentre, Randomized Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,794
- 试验地点
- 22
- 主要终点
- The rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group (Group A experimental) and the standard group (Group B Usual care)
研究概览
简要总结
Evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using POC multiplex technology before 18 weeks’ gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth (with previous history of preterm birth or late fetal loss), in comparison with a usual strategy with absence of screening.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women over 18 years of age
- •Single intra uterine pregnancy after 8 weeks and before 18 weeks of gestation (i.e. ≥ 8 weeks and ≤ 18 weeks). Woman can present symptomatic vaginal discharge, or can be asymptomatic or symptomatic with regard to the diagnosis of bacterial vaginosis (BV) with usual technics
- •With a history of preterm birth before 37 weeks of gestation (even if the preterm birth was following preterm rupture of membranes) and / or late miscarriage or fetal loss (i.e. miscarriage or foetal loss between 14 and 22 weeks of gestation), even if one any of her last birth occurred at term
- •Woman Affiliated to a social security regimen or equivalent
排除标准
- •Woman of legal age under legal protection
- •Woman presenting contraindications to the study treatments, in particular hypersensitivity to the active substance or to any of the excipients.
- •Ectopic pregnancy
- •Non-evolutive pregnancy or intrauterine fetal demise/death leading to preterm birth without other preterm birth
- •Woman with only history of preterm birth because of preeclampsia or intrauterine growth restriction but without a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population between 14 and 22 weeks of gestation)
- •Woman with history of preterm birth or voluntary fetal abortion or fetal abortion for medical indication but without a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population between 14 and 22 weeks of gestation).
- •Woman for who the history of preterm birth before 37 weeks of gestation or late miscarriage history is due to intra uterine demise before labor or voluntary abortion
- •Adult patient under guardianship or trusteeship, patient deprived of liberty
- •Nulliparous
- •Multiple pregnancy (twins, triplet or more)
- •Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, and diaphragmatic hernia, cerebral or spinal major anomaly.
- •Woman presenting uterine malformation (unicornuate, bicornuate, full septate)
- •Woman with preterm birth history because of twin pregnancy
- •Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study
- •Woman having received anti-infective treatment in the week preceding inclusion
研究组 & 干预措施
ROCEPHINE 1 g/3,5 ml, poudre et solvant pour solution injectable (IM)
Test
干预措施: ROCEPHINE 1 g/3,5 ml, poudre et solvant pour solution injectable (IM) (Drug)
MYCOHYDRALIN 500 mg, capsule vaginale
Test
干预措施: MYCOHYDRALIN 500 mg, capsule vaginale (Drug)
ZITHROMAX 250 mg, comprimé pelliculé
Test
干预措施: ZITHROMAX 250 mg, comprimé pelliculé (Drug)
GRANUDOXY 100 mg, comprimé pelliculé sécable
Test
干预措施: GRANUDOXY 100 mg, comprimé pelliculé sécable (Drug)
FLAGYL 500 mg, comprimé pelliculé
Test
干预措施: FLAGYL 500 mg, comprimé pelliculé (Drug)
结局指标
主要结局
The rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group (Group A experimental) and the standard group (Group B Usual care)
The rate of preterm birth before 37 weeks of gestation, which will be compared between the innovative group (Group A experimental) and the standard group (Group B Usual care)
次要结局
- Severity criteria of prematurity: the rates of delivery before 23, 24, 26, 28, 32 and 37 weeks of gestation
- Morbidity during pregnancy: The rate of preterm rupture of the membranes defined as clean break with evident flow of amniotic fluid and/or a positive Amnicator, AmniSure, Actim PROM (IGFBP-1) test
- Morbidity during pregnancy: The rate of late fetal loss ( name also late miscarriage) between 14 and 22 weeks of gestation
- Morbidity during pregnancy: The rate of fetal growth restriction defined as an abdominal and/or femoral circumference measurement < 5th percentile for the gestational age according to OMS
- Morbidity during pregnancy: The rate of endometritis characterized by a uterus that is painful on mobilization, the presence of purulent vaginal discharge (with the presence of altered leukocytes on vaginal swabbing) and hyperthermia >38°C requiring antibiotic therapy (with a negative result upon cytobacteriologic examination of the urine)
- Morbidity during pregnancy: The rate of spontaneous preterm birth calculated as follows: patients with caesarean section or labor induced before 37 weeks’ gestation for any of the following reasons: preeclampsia, retroplacental hematoma, fetal heart rhythm abnormality, fetal growth restriction or in utero fetal death of vascular origin, medical termination of pregnancy for fetal malformation or chromosomal abnormalities will be excluded from this adjusted preterm birth rate
- Morbidity during pregnancy: The rate of risk of preterm birth defined by uterine contractions occurring before 37 weeks’ gestation and/or a cervical length of less than 25 mm on vaginal ultrasound
- Morbidity during pregnancy: The rate of progestative treatment
- Morbidity during pregnancy: The rate of emergency cerclage
- Total inpatient stay: the total length, antepartum and postpartum, of hospitalization for mother and newborn in number of days (including conventional hospitalization, day hospitalization and hospitalization at home, hospitalization in neonatology or intensive care unit)
- Neonatal mortality: the rate of death after 22 weeks’ gestation and until hospital discharge
- Neonatal morbidity, which will be compared between the innovative group and the standard group until hospital discharge, by the occurrence of the following clinical events: respiratory distress syndrome, bronchopulmonary dysplasia, rate of `intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, sepsis, retinopathy of prematurity, newborns admitted to intensive care unit, mechanical ventilation, length of stay in intensive care unit.
- The rate of spontaneous abortion before 14 weeks’ gestation (13 weeks and 6 days) and before 22 week's gestation.
- In Group A: The effectiveness of the treatment will be assessed by comparing the quantitative loads of hosts quantified by molecular biology before and after treatments.
- In group A: The rate of successful treatment (determined by a negative molecular analysis at the first vaginal sample control)
- In group A: The rate of recurrence will be determined by molecular analysis during follow-up of positive patients and defined as a positive result after a negative result control in this group of patients.
- In group A: the rate of positivity for each host before and after treatments
- In group A: The rate of preterm birth of women with an initial success of treatment (based on a negative result for the screening test conducted for recurrence)
- In group A: The rate of preterm birth among women with either a positive POC or a negative POC test
- In group A: The rate of preterm birth according to the results of POC and the specy
- In group B: The proportion, type of screening and management of BV and its recurrence detected by traditional methods (Nugent score, etc.) for the standard strategy. The proportion of women under 25 years or at risk of sexual transmitted infection, positive for C. trachomatis.
- Health economic: Incremental cost-effectiveness ratio
- Health economic: Budget impact
- Health economic: Indicators of process
- Exploratory: description of the metagenomic and culturomic analysis performed on a sample of patients.
研究者
Pr. Florence BRETELLE
Scientific
Assistance Publique Hopitaux De Marseille
研究点 (22)
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