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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Cerclage (CC) | Active Comparator | 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. |
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| Vaginal Progesterone Therapy (VPT) | Active Comparator | 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. |
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| Combined Therapy (CC/VPT) | Active Comparator | Participants receive both the surgical Cervical Cerclage procedure and the daily Vaginal Progesterone inserts as described in the individual arms above. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McDonald Cervical Cerclage | Procedure | The procedure involves exposing the cervix and grasping it with ring forceps. A purse-string suture using No. 1 or 2 braided or monofilament material is placed at the 12 o'clock position with a curved needle. The needle is inserted at the junction of the vaginal epithelium and the cervix, approximately 2 cm above the external os and distal to the vesicocervical reflection. After 5-6 cautious bites, the stitch is pulled tight to close the internal os. The suture is typically removed at 37 weeks of gestation, provided there is no labor or membrane rupture. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration | 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. | 6-7 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Benha University | Banhā | Qalyubia Governorate | 13511 | Egypt |
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| Vaginal Progesterone Therapy (VPT) | Drug | Participants receive 100 mg vaginal progesterone inserts. Dosage & Frequency: One 100 mg insert administered twice daily. Duration: The treatment continues until the onset of spontaneous labor or until the 37th week of pregnancy. |
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