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临床试验/NCT02511574
NCT02511574已完成4 期

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Henrique Burlacchini de Carvalho

Professor Doutor

University of Sao Paulo

研究点 (1)

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