NCT02901626终止3 期
A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
The George Washington University Biostatistics Center23 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2017年2月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 544
- 试验地点
- 23
- 主要终点
- Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.
研究概览
简要总结
The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.
详细描述
While cervical length is one of the most powerful predictors of subsequent preterm birth, the best treatment to reduce subsequent preterm birth remains unknown. This study is a randomized trial of women who have a singleton pregnancy and a short cervical length on transvaginal ultrasound as determined by a study-certified sonographer. It is being conducted at 12 clinical centers across the country and the recruitment target is enrollment of 850 pregnant women. Participants will be randomized to 1) Arabin pessary or 2) usual care as per by local hospital protocol. Pessary is a promising low-cost, non-surgical intervention that appears to be well-tolerated. The pessary will be placed by obstetric providers trained in appropriate placement of the Arabin pessary. The primary outcome of the study is delivery or fetal death prior to 37 weeks 0 days gestational age.
In the literature, there are two large trials that have produced conflicting results (M Goya et al, 2012, K Nicolaides et al, 2016). Thus, the results of an adequately powered and appropriately conducted trial from the United States will be important in determining whether pessary is a useful intervention for the prevention of subsequent preterm birth in women with singleton gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation. Twin gestation reduced to singleton either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher order multifetal gestations reduced to singletons are not eligible.
- •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 or equal to 20 mm by a study certified sonographer. There is no lower cervical length threshold.
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.
- •Fetal anomaly 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 Estimated Date of Confinement (EDC) must be performed prior to randomization to evaluate the fetus for anomalies.
- •Previous spontaneous preterm birth between 16 weeks 0 days and 36 weeks 6 days. This includes induction for pPROM in a prior pregnancy.
- •Planned treatment with intramuscular 17-α hydroxy-progesterone caproate.
- •Placenta previa, because of risk of bleeding and high potential for indicated preterm birth. A low lying placenta is acceptable.
- •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 because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized. However, if it is more than 10 days since the cervical length measurement, a new cervical length measurement must be obtained.
- •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.
- •More than six contractions per hour reported or documented prior to randomization. It is not necessary to place the patient on a tocodynamometer.
- •Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery which is unlikely to be affected by progesterone.
- •Any fetal/maternal condition which would require invasive in-utero assessment or treatment, for example significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.
- •Major maternal medical illness associated with increased risk for adverse pregnancy outcome or indicated preterm birth (treated hypertension requiring more than one agent, treatment for diabetes prior to pregnancy, chronic renal insufficiency defined by creatinine >1.4 mg/dL, carcinoma of the breast, conditions treated with chronic oral glucocorticoid therapy). Lupus, uncontrolled thyroid disease, and New York Heart Association(NYHA) stage II or greater cardiac disease are also excluded. Patients with seizure disorders, HIV, and other medical conditions not specifically associated with an increased risk of indicated preterm birth are not excluded. Prior cervical cone/LOOP/Loop Electrocautery Excision Procedure (LEEP) is not an exclusion criterion.
- •Planned cerclage or cerclage already in place since it would preclude placement of a pessary.
- •Planned indicated delivery prior to 37 weeks.
- •Allergy to silicone.
- •Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality.
- •Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
- •Prenatal care or delivery planned elsewhere unless the study visits can be made as scheduled and complete outcome information can be obtained.
研究组 & 干预措施
No Pessary
No Intervention
Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Arabin Cervical Pessary
Experimental
Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
干预措施: Arabin Cervical Pessary (Device)
结局指标
主要结局
Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.
时间窗: Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.
Participants who either delivered or experienced a fetal death prior to 37 weeks gestation.
次要结局
- Interval From Randomization to Delivery or Fetal Death(from randomization to delivery or fetal death (up to a length of 189 days))
- Number of Participants With Cesarean Delivery(From randomization to delivery (up to a length of 189 days))
- The Number of Participants Who Had a Vaginal Infection and Received Antibiotic Treatment, Among All Persons Enrolled With at Least One Study Visit(From randomization to delivery (up to a length of 189 days))
- Number of Neonates Requiring Ventilator or Continuous Positive Airway Pressure Use(delivery through hospital discharge (up to a length of 435 days))
- Number of Participants With Preterm Delivery or Fetal Death at Less Than 32 Weeks Gestation(from randomization to less than 32 weeks gestation (a period of less than 119 days))
- Number of Participants With Preterm Delivery or Fetal Death at Less Than 35 Weeks Gestation(from randomization to less than 35 weeks gestation (a period of less than 140 days))
- Median Duration of Neonatal Ventilator or Continuous Positive Airway Pressure Use(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Bronchopulmonary Dysplasia (BPD)(Delivery through 28 days of life if delivered at or after 32 weeks. Delivery through 36 weeks gestation if delivered before 32 weeks.)
- Number of Participants With Preterm Premature Rupture of Membranes(Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment)
- Number of Participants With Indicated Preterm Delivery(from randomization to delivery (up to a length of 189 days))
- Gestational Age at Delivery(From randomization to delivery (up to a length of 189 days))
- Number of Participants With Preterm Delivery or Fetal Death at Less Than 28 Weeks Gestation(from randomization to less than 28 weeks gestation (a period of less than 91 days))
- Number of Participants With Chorioamnionitis(From randomization to delivery (up to a length of 189 days))
- Number of Participants With Spontaneous Preterm Delivery.(From randomization to delivery (up to a length of 189 days))
- Number of Neonates With Seizures Requiring Treatment(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Hyperbilirubinemia(delivery through hospital discharge (up to a length of 435 days))
- Median Length of Maternal Antepartum Hospital Stay Before Delivery(from date of admission for delivery up to delivery date (up to 5 days))
- Median Duration (in Days) of Neonatal Supplemental Oxygen Use(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Retinopathy of Prematurity (ROP)(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates Experiencing Respiratory Distress Syndrome (RDS)(delivery through hospital discharge (up to a length of 435 days))
- Median Length of Neonatal Hospital Stay(delivery through hospital discharge (up to a length of 435 days))
- Number of Participants With Vaginal Infection(From randomization to delivery (up to a length of 189 days))
- Number of Participants Treated for Preterm Labor Including Placement of Cerclage(From randomization to delivery (up to a length of 189 days))
- Number of Neonates With Intraventricular Hemorrhage (IVH) Grades III or IV(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Late Onset Sepsis(72 hours of birth or later (up to hospital discharge - a maximum of 435 days))
- Median Number of Days in Neonatal Intensive Care Unit (NICU)(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates Small for Gestational Age < 5th Percentile(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Necrotizing Enterocolitis (NEC) Stage 2 or 3(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Pneumonia(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Composite Outcome(delivery through hospital discharge (up to a length of 435 days))
- Neonatal Infectious Morbidity Including Sepsis, Suspected Sepsis and Pneumonia(delivery through hospital discharge (up to a length of 435 days))
- Number of Neonates With Early Onset Sepsis(within 72 hours of birth)
- Number of Neonates With Suspected Sepsis(delivery through hospital discharge (up to a length of 435 days))
研究者
研究点 (23)
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