Combined Cervical Cerclage and Vaginal Progesterone May Readjust the Deregulated Cervicovaginal Fluid Inflammatory Milieu and Improve Outcomes of Twin Pregnant Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration
研究概览
简要总结
Twin pregnancies face a high risk of complications, most notably preterm birth (delivery before 37 weeks), which is a major cause of infant death and illness globally. For women carrying twins who are identified as having a short cervical length (cervix measuring 25 millimeters or less), there is currently no single, highly effective preventative treatment. This study is a randomized clinical trial designed to determine if a combined therapy of Cervical Cerclage (a surgical stitch to support the cervix) and Vaginal Progesterone (a hormone medication) is more effective than standard care in preventing preterm birth and improving the overall health outcomes for both the mother and the babies. The trial will also investigate the biological basis of this effect by measuring specific inflammation markers (cytokines like Interleukin-1$\beta$, 6, 8, and Tumor Necrosis Factor-α) in the cervical fluid before and after the intervention, to see if the combined treatment helps to reduce harmful local inflammation.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Type of Pregnancy: Women with confirmed twin pregnancy (TP).
- •Cervical Length: Short cervical length (CL) defined as ≤25 mm.
- •Timing of Diagnosis: Short cervix detected via transvaginal ultrasound (TVU) at 11-13 weeks + 6 days, or detected during bi-weekly follow-up exams until 23 weeks + 6 days.
- •Consent: Participants willing to undergo randomization and comply with the follow-up protocol.
排除标准
- •Multiple Gestation (High Order): Triplet or higher-order pregnancies.
- •Fetal/Uterine Complications: Polyhydramnios, premature rupture of membranes (PPROM), or known uterine abnormalities.
- •Acute Symptoms: Vaginal bleeding, fever, or signs of fetal distress.
- •Maternal Comorbidities: Pre-existing or gestational hypertension, and diabetes mellitus.
研究组 & 干预措施
Cervical Cerclage (CC)
Participants in this arm undergo a McDonald cerclage technique. This involves placing a purse-string suture (No. 1 or 2 braided or monofilament) around the cervix to close the internal os. The suture is typically removed at 37 weeks of gestation.
干预措施: McDonald Cervical Cerclage (Procedure)
Vaginal Progesterone Therapy (VPT)
Participants receive 100 mg vaginal progesterone inserts (e.g., Endometrin) administered twice daily. This treatment continues until spontaneous labor occurs or until the 37th week of pregnancy.
干预措施: Vaginal Progesterone Therapy (VPT) (Drug)
Combined Therapy (CC/VPT)
Participants receive both the surgical Cervical Cerclage procedure and the daily Vaginal Progesterone inserts as described in the individual arms above.
干预措施: McDonald Cervical Cerclage (Procedure)
Combined Therapy (CC/VPT)
Participants receive both the surgical Cervical Cerclage procedure and the daily Vaginal Progesterone inserts as described in the individual arms above.
干预措施: Vaginal Progesterone Therapy (VPT) (Drug)
结局指标
主要结局
Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration
时间窗: 6-7 Months
The proportion of patients who achieved a pregnancy duration of 37 weeks or more and/or significantly delayed delivery, reflecting the effectiveness of the administered treatment regimens (Cervical Cerclage, Vaginal Progesterone, or Combined Therapy) in high-risk twin pregnancies.
次要结局
未报告次要终点
研究者
Adel Farag Al Kholy
Professor of Medical Biochemistry
Benha University