Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth in Pregnant Women With a Uterine Cervix Measuring 25 mm or Less in Length
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Spontaneous preterm birth before 34 weeks of gestational age
研究概览
简要总结
The aim of this study is to compare the effectiveness between the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervical length of 25 mm or less evaluated by transvaginal ultrasonography.
详细描述
Preterm birth is the leading cause of perinatal morbidity and mortality. The rates of spontaneous premature labor have not changed much during the past 10 years. A significant decrease in mortality and morbidity of premature babies will only be possible if women at risk of spontaneous preterm birth are accurately identified and administered preventive therapies. Ultrasonographic measurement of the cervix between 20 and 24 weeks of gestation can improve the identification of both women with single pregnancies and those with twin pregnancies at risk. Asymptomatic women with a short uterine cervix (25 mm or less) are at increased risk of spontaneous premature labor.
The prophylactic use of progesterone during the early phase of pregnancy in women with a history of preterm birth and those with a short cervix can prevent preterm birth.
The cervical pessary is a device used also for the prevention of preterm birth. Vaginal infections are also important causes of preterm birth. There are not many studies about the vaginal microbiome in pregnant women.
Measurement of cervical length is used as a screening test because it is inexpensive, has a short learning curve, and is well tolerated by patients. In addition, placement and removal of the pessary is an easy, accessible, and noninvasive procedure. The results on the concentration of omega 3 and preterm birth are still conflicting.
The aim of this study is to compare the effectiveness of the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervix measuring 25 mm or less in length as evaluated by transvaginal ultrasonography, assess whether there is a relationship between maternal plasma concentration of omega 3 and preterm birth, and compare the microbiome in these women.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age between 20 weeks and 23 weeks and 6 days
- •singleton pregnancies
排除标准
- •fetal death at randomization
- •major structural or chromosomal abnormality
- •cervical cerclage in the current pregnancy
- •preterm rupture of membranes diagnosed before randomization
研究组 & 干预措施
cervical pessary
Patients with uterine cervical length ≤ 25 mm are randomized to use the cervical pessary or natural progesterone to compare their effectiveness in the reduction of preterm birth rates.
干预措施: cervical pessary (Device)
natural progesterone
Patients with uterine cervical length ≤ 25 mm are randomized to use the cervical pessary or natural progesterone to compare their effectiveness in the reduction of preterm birth rates.
干预措施: natural progesterone (Drug)
结局指标
主要结局
Spontaneous preterm birth before 34 weeks of gestational age
时间窗: before 34 weeks of gestation
All births that occurred before 34 weeks of gestation were included, excluding iatrogenic births (medically indicated).
次要结局
- Overall preterm birth before 37, 34, 32 and 30 weeks of gestational age(before 37, 34, 32 and 30 weeks of gestation)
- Spontaneous preterm birth before 37, 32 and 30 weeks of gestational age(before 37, 32 and 30 weeks of gestation)
- Adverse neonatal events(Neonatal period (up to 27 days after birth))
- The need of neonatal special care(Neonatal period (up to 27 days after birth))
研究者
Mario Henrique Burlacchini de Carvalho
Professor Doutor
University of Sao Paulo
