Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pediatrix
- 主要终点
- Rate of very preterm birth (PTB)
研究概览
简要总结
A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (</= 15.0mm) between 16w0d to 25w6d.
详细描述
A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Twin pregnancy (see Exclusion Criterion (a) below re: monochorionic twins)
- •Gestational age 16 0/7 to 25 6/7 weeks at time of enrollment by best-estimated age.
- •Cervical length 0.1 to 15.0 mm on transvaginal ultrasound examination. (Cervical length is taken to mean the length of the closed portion of the cervical canal.
排除标准
- •Maternal age less than 18 years
- •Monochorionic twins (such as monochorionic-diamniotic, monochorionic-monoamniotic, or conjoined twins)
- •Rupture of membranes, either twin
- •One or both twins has no cardiac activity
- •One or both twins has known or suspected major malformation, aneuploidy, or polyhydramnios
- •Maternal congenital uterine anomaly (such as bicornuate uterus, unicornuate uterus)
- •Pregnancy started as triplets or higher-order multifetal gestation and then reduced to twins, either spontaneously or via procedure
- •Symptomatic uterine contractions, 6 or more per hour
- •Ongoing bleeding from uterus
- •Patient declines to consider cerclage
- •Patient declines treatment with vaginal progesterone
- •Allergy to progesterone or peanuts (because the vaginal progesterone formulation used will be a capsule of micronized progesterone in peanut oil.)
- •Cerclage is already in place
- •Cerclage placement is judged to be technically impossible
- •Patient has a history of poor follow-up or poor adherence to physician recommendations
- •Patient is planning to relocate outside the local area before the end of pregnancy such that delivery records will be unavailable
- •Patient does not give consent to participate in this trial.
研究组 & 干预措施
Cervical Cerclage + Progesterone
Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)
干预措施: Cervical Cerclage placement (Procedure)
Cervical Cerclage + Progesterone
Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab)
干预措施: Vaginal Progesterone (Drug)
Progesterone
Daily administration of vaginal progesterone (200mg tab)
干预措施: Vaginal Progesterone (Drug)
结局指标
主要结局
Rate of very preterm birth (PTB)
时间窗: Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks.
Rate of very PTB (PTB less than 32 weeks)
Rate of adverse perinatal outcome
时间窗: Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks.
The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis.
次要结局
未报告次要终点