"Comparison of Vaginal Progesterone With Arabin Cervical Pessary and Vaginal Progesterone Alone in the Prevention of Preterm Delivery in Singleton Pregnancies With Incidental Premature Shortening of Cervical Length"
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Preterm delivery before 37 weeks
研究概览
简要总结
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This will be a randomized prospective and open-label study with no placebo control or blinding of the participants and the research team members. The study is to compare the effectiveness of vaginal progesterone versus combination of vaginal progesterone and Arabin cervical pessary in the prevention of preterm delivery among patients with incidental shortened cervical length.
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As part of standard clinical care, all pregnant patients usually have cervical length measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the GE ultrasound Volusion 8 using the vaginal probe.
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Patients with short cervix will be counseled and offered the opportunity to participate in the study.
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All participants will be taught how to use the vaginal progesterone once daily prior to bedtime. In addition, those in the combination group will have the cervical pessary placed in the clinic right away or within a week if they request for more time to brood over their diagnosis and weigh on the option of inserting Arabin pessary.
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All participants will be followed up in the high-risk obstetric clinic as per standard prenatal care. Frequency of follow up visits will be individualized depending on patient's need and comorbidities. , Participants will be requested to bring the remnant of the vaginal progesterone to the clinic to assess compliance.
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Participants in the study will continue their prenatal care with UIC high-risk obstetric clinic until delivery.
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The study recruitment will occur for a period of 2 years starting from November 2016 to October 2018 or until all the anticipated numbers of study subjects have been attained.
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There will be 10 % over-sampling to cater for those who will drop out from the study or loss to follow up after randomization, and those who delivered in another hospital.
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Participants will have access to one of the investigators or the high- risk clinic nurse for any complaints related to their conditions.
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Participants can opt out at any stage of the study if they do not want to continue further or if there are any adverse effects.
详细描述
Preterm birth is the leading cause of neonatal mortality and disability in survivors in the United States. Short cervical length measured by transvaginal ultrasound has been strongly associated with an increased risk of preterm birth. Vaginal progesterone has been proposed as a management option to reduce the risk of preterm birth in asymptomatic women with singleton gestations without prior preterm birth with a very short cervical length. Short cervix in this population is defined as less than or equal to 20 mm, when measured between 18 and 24 weeks.
The American College of Obstetrics and Gynecology (ACOG) and the Society of Maternal Fetal Medicine (SMFM) have proposed the use of vaginal progesterone either micronized progesterone capsule, 200mg daily, or vaginal progesterone gel, 90 mg daily, in asymptomatic women carrying a singleton pregnancy and an incidental finding of short cervix.
Cervical length is usually measured at time of routine anatomical survey fetal between 18 and 24 weeks of gestation for the prevention of preterm birth at less than 37 weeks.
Furthermore, cervical pessary has been used in the prevention of preterm birth for many decades in a few studies with promising results. More recently, the Arabin pessary has been designed with the sole purpose of prevention of preterm birth in pregnant patients with short cervix. It is relatively noninvasive, not operator-dependent and can be easily placed and removed in the outpatient setting.
The purpose of this study is to test the hypothesis that adding the use of the Arabin pessary for women identified with short cervix and undergoing the standard of care treatment with vaginal progesterone, further decreases the risk of preterm birth.
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
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Short cervical length equal or less than 20 mm
- •Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries.
- •18 years or older at the time of enrollment.
- •Consent to participate in the study
排除标准
- •Previous preterm delivery less than 37 weeks
- •Major fetal anomalies
- •Multiple pregnancy
- •Patient currently with cervical cerclage in-situ for the treatment of incompetence cervix.
- •Regular uterine contractions or significantly dilated cervical canal
- •Age less than 18 years
- •Decline to participate in the study
研究组 & 干预措施
Vaginal progesterone and Pessary
- Short cervical length equal or less than 20 mm
- Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries.
- 18 years or older at the time of enrollment.
- Consent to participate in the study
Vaginal progesterone as standard of care plus Arabin pessary
干预措施: Arabin Pessary (Drug)
Vaginal progesterone only
- Short cervical length equal or less than 20 mm
- Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries.
- 18 years or older at the time of enrollment.
- Consent to participate in the study
Vaginal progesterone as standard of care
干预措施: Arabin Pessary (Drug)
结局指标
主要结局
Preterm delivery before 37 weeks
时间窗: 2 years
1. To compare the effectiveness of the combination of vaginal progesterone and Arabin pessary in the prevention of preterm delivery prior to 37 weeks compared to vaginal progesterone alone.
次要结局
- Preterm delivery before 28 weeks(2 years)
- Preterm delivery before 32 weeks(2 years)
- Preterm delivery before 34 weeks(2 years)
研究者
Mary Stephenson
Professor of Obstetrics and Gynecology
University of Illinois at Chicago