Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Preterm delivery (37 weeks of gestation)
研究概览
简要总结
Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in the present pregnancy.
Main outcome: Delivery before 37 weeks.
Secondary outcomes: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies.
Allocated treatments will be:
Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation
Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded.
Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting.
Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients.
Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.
详细描述
Background: According to the last reviews Progesterone (P) and (17P) are able to reduce preterm delivery (PTD), either as prophylactic administration in the presence of previous PTD or as a treatment of the actual pregnancy, becoming at risk because of cervical shortening/preterm labour. At present is difficult to distinguish the clinical effects of P from the one of 17P as well as it is impossible to choice among the diverse doses and formulations utilized in the RCTs published so far, as well as in those under recruitment.
Protocol: Women will be treated with P, 17P or just clinically observed according to on-line randomization assignment provided by the Methodological Unit. Treatments end at the completion of 36th week. Randomization will be stratified for early (22-27+6th) and late (28-31+6th wks) PTD risk. Interim analysis will be done at 50% enrollment.
Sixty women will be allocated to each Clinical Centre to reach 480 enrollments, in the 3 arms.
Drugs will be provided by manufacturers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with singleton pregnancy at 22+0nd to 31+6nd week of gestation presenting with a cervical length ≤25 mm, after an episode of preterm labour.
排除标准
- •Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, mullerian malformations, cervical surgery (cervical cerclage etc), presence of regular uterine contractions
研究组 & 干预措施
17 alfa hydroxy Progesterone caproate
Women treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy)
干预措施: 17 alpha-hydroxy progesterone caproate (Drug)
Micronized Progesterone
micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium)
干预措施: micronized Progesterone (Drug)
Control
Routine clinical controls
干预措施: Control (Procedure)
结局指标
主要结局
Preterm delivery (37 weeks of gestation)
时间窗: 6 mo. after end of recruitment
次要结局
- Gestational age at delivery(6 months after the end of the study)
- congenital neonatal anomalies(6 months after the end of the study)
- Delivery <32, <35 wks(6 months after the end of the study)
- Hospital admissions before delivery(6 months after the end of the study)
- Birth-weight centile(6 months after the end of the study)
- NICU admission(6 months after the end of the study)
- days of NICU admission(6 months after the end of the study)
- days of oxygen supply(6 months after the end of the study)
- congenital neonatal malformations(6 months after the end of the study)
- composite neonatal complications(6 months after the end of the study)
研究者
Prof. Facchinetti Fabio
Chairman of Obstetric-Gynecology Unit
University of Modena and Reggio Emilia