Vaginal Progesterone in Twins With Short Cervix
2014年12月17日 更新者：Obstetrix Medical Group
Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy With Short Cervix. Double-Blind, Placebo-Controlled, Randomized Clinical Trial
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
研究概览
详细说明
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.
研究类型
介入性
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Jose、California、美国、95008
- Good Samaritan Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Vaginal Progesterone
Daily administration of Vaginal Progesterone (200mg) Gel between 20 weeks of pregnancy and 34 weeks of pregnancy.
|
Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.
其他名称：
Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms.
Randomziation occurs between 20 weeks - 24 weeks of gestation.
其他名称：
|
|
安慰剂比较：Placebo
Daily vaginal administration of Placebo gel (Vanicream)between 20 weeks of pregnancy and 34 weeks of pregnancy.
|
Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms.
Randomziation occurs between 20 weeks - 24 weeks of gestation.
其他名称：
weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Birth of baby before 34 weeks of gestation
大体时间：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.
|
At the time of delivery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gestational age of baby at birth
大体时间：measure at time of birth
|
measured of the average Gestational age of babies at birth.
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measure at time of birth
|
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Rate of "spontaneous birth" before 34weeks of gestation
大体时间：from randomization to birth of the baby - up to 15 weeks
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Rate of "spontaneous birth" before 34weeks of gestation.
Spontaneous births are those whose underlying cause is judged to be due to preterm labor, prelabor rupture of membranes, or cervical insufficiency.
(In contradistinction, "indicated" deliveries are those due to preeclampsia, fetal growth problems, fetal heart rate abnormalities, and other problems.)
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from randomization to birth of the baby - up to 15 weeks
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Rate of composite neonatal morbidity
大体时间：measures from randomization to 60 days post delivery of the baby
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Composite morbidity is defined as any one or more of: stillbirth, neonatal death, infant death before hospital discharge, respiratory distress syndrome (RDS), intracranial hemorrhage (grade 3 or 4)(IVH), necrotizing enterocolitis (stage 2 or 3)(NEC), documented neonatal sepsis within 72 hr of birth, or periventricular leukomalacia (characteristic lesions in the subcortical white matter seen on cerebral imaging studies within 96 hrs of birth)(PVL).
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measures from randomization to 60 days post delivery of the baby
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of effectiveness of progesterone in women in highest 2 quartiles of quantitative fetal fibronectin (fFN) versus those in the lowest 2 quartiles of quantitative fFN.
大体时间：from the 21st week of gestation until the 25 week of gestation
|
A cervicovaginal swab for quantitative fetal fibronectin testing will be obtained at the first antenatal visit, approximately 1 week after enrollment.
The results of this will be used to test a secondary hypothesis that fFN levels will identify a subgroup of participants who respond to progesterone treatment and another subgroup who do not.
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from the 21st week of gestation until the 25 week of gestation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrew Combs, MD、Mednax Center for Research, Education, Quality and Safety
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年3月1日
初级完成 (预期的)
2017年8月1日
研究完成 (预期的)
2018年8月1日
研究注册日期
首次提交
2013年3月12日
首先提交符合 QC 标准的
2013年3月15日
首次发布 (估计)
2013年3月18日
研究记录更新
最后更新发布 (估计)
2014年12月19日
上次提交的符合 QC 标准的更新
2014年12月17日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.