A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
概览
- 阶段
- 3 期
- 干预措施
- Vaginal progesterone
- 疾病 / 适应症
- Short Cervical Length
- 发起方
- The George Washington University Biostatistics Center
- 入组人数
- 1311
- 试验地点
- 28
- 主要终点
- Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.
详细描述
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. Multiple gestation increases the risk of preterm delivery. Babies born preterm have increased rates of neonatal mortality and long-term neurodevelopmental morbidities. Short cervical length is known to be an important risk factor for spontaneous preterm birth and to occur more frequently in women with a twin gestation. Although there is no evidence that progesterone reduces the risk of preterm birth in multifetal gestation, there is evidence that progesterone reduces the risk of prematurity in singleton gestations complicated with a short cervix. The Arabin pessary has also been shown to reduce the risk of preterm birth among singletons with a short cervix, and in a secondary subgroup analysis of a recent study of the use of pessary in multiple gestations, women with a cervical length \< 25th percentile had a significantly reduced risk of the primary composite neonatal adverse outcome. Secondary analysis of studies of vaginal progesterone in multiple gestation with a short cervix also suggest a possible beneficial effect on preterm delivery.
研究者
入排标准
入选标准
- •Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
- •Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
- •Cervical length on transvaginal examination of less than 30 mm by a study certified sonographer.
排除标准
- •Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization. There is no lower threshold of cervical length measurement threshold on ultrasound that is an exclusion criterion.
- •Monoamniotic gestation, due to increased risk of adverse pregnancy outcome
- •Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome
- •Evidence of severe IUGR (intrauterine growth restriction) (\<5th percentile for gestational age) in either fetus
- •Fetal anomaly in either twin or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project EDC (estimated date of conception) must be performed prior to randomization to evaluate the fetuses for anomalies.
- •Placenta previa, because of risk of bleeding and high potential for indicated preterm birth
- •Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement.
- •Symptomatic, untreated vaginal or cervical infection, also because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized.
- •Active, unhealed herpetic lesion on labia minora, vagina, or cervix due to the potential for significant patient discomfort or increasing genital tract viral spread. Once lesion(s) heal and the patient is asymptomatic, she may be randomized. History of herpes is not an exclusion.
- •Rupture of membranes due to likelihood of pregnancy loss and preterm delivery as well as the risk of ascending infection which could be increased with pessary placement
研究组 & 干预措施
Progesterone
vaginal progesterone capsule
干预措施: Vaginal progesterone
Placebo
placebo capsule
干预措施: Placebo
Arabin Pessary
Arabin Pessary
干预措施: Arabin Pessary
结局指标
主要结局
Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation
时间窗: From randomization to 35 weeks gestation (a period of up to 19 weeks)
Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation
次要结局
- Days From Randomization to Delivery (or Fetal Demise)(Randomization to delivery (a period of up to 26 weeks))
- Gestational Age at Delivery or Fetal Death(Randomization to delivery (a period of up to 26 weeks))
- Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation(From randomization to up to 28 weeks gestation (a period if up to 12 weeks))
- Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation(From randomization to 32 weeks gestation (a period of up to 16 weeks))
- Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation(randomization to 37 weeks gestation (a period of up to 21 weeks))
- Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation(randomization to 32 weeks gestation (a period of up to 16 weeks))
- Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation(randomization to 35 weeks gestation (a period of up to 19 weeks))
- Number of Participants With Indicated Preterm Delivery for < 35 Weeks(randomization to 35 weeks gestation (a period of up to 19 weeks))
- Number of Participants With Cesarean Delivery(Randomization to delivery (a period of up to 26 weeks))
- Number of Fetal, Neonatal or Infant Deaths(From randomization to up to 28 days post birth (a period of up to 30 weeks))
- Number of Neonates Small for Gestational Age < 5th Percentile(randomization to delivery (a period of up to 26 weeks))
- Number of Neonates With the Composite Neonatal Outcome(Birth to neonatal discharge or death, whichever is first (up to 70 weeks))
- Number of Neonates Admitted to Intensive Care (NICU) or Intermediate Care(Birth to the time of NICU or Intermediate Care Admission, whichever came first (a maximum of 10 days))
- Length of Neonatal Hospital Stay in Days(admission to hospital discharge (a median of 12 days with a maximum of 490 days))
- Length of Stay in Neonatal Intensive Care (NICU) or Intermediate Care in Days(admission to discharge from NICU or intermediate care (a median of 28 days, with a maximum of 491 days))