Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 3
- 主要终点
- The rate of preterm spontaneous delivery
研究概览
简要总结
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
详细描述
Since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment.
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •Tocolytic treatment between 24+0 and 34+0 weeks
- •Patient's consent to participate in this study
- •24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
- •Arrest of preterm labor
- •Exclusion Criteria
- •Contraindication to ongoing pregnancy including:
- •Suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater
- •Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
- •Intrauterine fetal death diagnosed at the time of admission
- •Major fetal malformation
- •Known maternal allergy to progesterone
- •Current use of progesterone at the time of admission
- •Breast cancer
- •PPROM (preterm premature rupture of membranes) during testing for eligibility
- •Age below 18 years
- •Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care)
- •History of deep vein thrombosis
- •Major active psychiatric disorders (major affective disorders and psychotic disorders)
- •Uncontrolled chronic hypertension
- •Heart failure
- •Chronic renal failure
- •Pre-gestational diabetes with known target organ damage
- •History of spontaneous preterm delivery
- •Previous tocolytic treatment during the current pregnancy
排除标准
- 未提供
研究组 & 干预措施
micronized progesterone 400 mg
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
干预措施: micronized progesterone 400 mg (Utrogestan) (Drug)
结局指标
主要结局
The rate of preterm spontaneous delivery
时间窗: Up to 13 weeks
defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation
The mean number of days from enrollment to delivery
时间窗: Up to 18 weeks
次要结局
- Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation(Up to 13 weeks)
- Pregnancy prolongation beyond one week(Up to 18 weeks)
- Admission to the NICU (neonatal intensive care unit)(From delivery and up to 28 days)
- Fetal/neonatal death(Around delivery)
- Birth weight and the rate of small for gestational age neonates(Around delivery)
- The rate of chorioamnionitis and endometritis(around delivery and up to 1 week post-partum)
- Adverse medication reactions(Up to 13 weeks)
- Need for repeated acute tocolysis(Up to 13 weeks)
- Length of NICU stay(From delivery and up to 3 months)
- The rate of neonatal complications(From delivery and up to 3 months)
- Number of hospitalizations and length of stay until 36.6 gestational weeks(Up to 13 weeks)
- The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)(Up to 13 weeks)
- Length of neonate hospital stay(From delivery and up to 3 months)
- Postpartum hemorrhage(From delivery and up to 1 week post-partum)
- Revision of uterine and cervix and reasons for the procedure(During the 48 hours from delivery)
- Urinary tract or vulvovaginal infection until 36.6 weeks(Up to 13 weeks)
研究者
Zohar Nachum
Principal Investigator
HaEmek Medical Center, Israel