Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Birth of baby before 34 weeks of gestation
研究概览
简要总结
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
详细描述
This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age between 20w0d and 24w0d
- •Twin pregnancy, diamniotic-dichorionic, both twins living
- •Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam
排除标准
- •Mother less than 18 years of age
- •Uterine contractions of 40 seconds duration or more, 10 or more per hour
- •Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
- •Ongoing vaginal bleeding
- •Any condition likely to cause serious neonatal morbidity independent of gestational age, including:
- •fetal malformation likely to require surgery
- •fetal malformation involving vital organs
- •fetal viral infection
- •hydrops fetalis
- •discordance in estimated fetal weight more than 10%
- •velamentous insertion of umbilical cord of either twin
- •placenta previa of either placenta
- •Any contraindication to continuing the pregnancy
- •Cervical cerclage in place or planned
- •Any contraindication to vaginal micronized progesterone, including:
- •Known sensitivity to progesterone or any of the other ingredients
- •Liver dysfunction or disease
- •Known or suspected malignancy of breast or genital organs
- •Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder
研究组 & 干预措施
Vaginal Progesterone
Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
干预措施: Vaginal Progesterone gel. (Drug)
Vaginal Progesterone
Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
干预措施: fetal fibronectin swab. (Procedure)
Placebo
Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
干预措施: fetal fibronectin swab. (Procedure)
Placebo
Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
干预措施: Placebo gel (Drug)
结局指标
主要结局
Birth of baby before 34 weeks of gestation
时间窗: At the time of delivery
The primary outcome is defined as Early Preterm Birth, that is, birth before 34weeks of gestation. A birth at 33weeks 6days or earlier is considered to have the primary outcome. A birth at 34weeks 0days or later does not have the primary outcome. Births for any reason before 34weeks 0days are considered to have the primary outcome, whether they are "spontaneous" or not.
次要结局
- Rate of "spontaneous birth" before 34weeks of gestation(from randomization to birth of the baby - up to 15 weeks)
- Rate of composite neonatal morbidity(measures from randomization to 60 days post delivery of the baby)
- Gestational age of baby at birth(measure at time of birth)