NCT07319715

Cerclage and Progesterone for Twin Pregnancies

Combined Cervical Cerclage and Vaginal Progesterone May Readjust the Deregulated Cervicovaginal Fluid Inflammatory Milieu and Improve Outcomes of Twin Pregnant Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Twin Pregnancy With Antenatal Problem

Interventions

Type	Name	Description
PROCEDURE	McDonald Cervical Cerclage	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.
DRUG	Vaginal Progesterone Therapy (VPT)	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.

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-08-24
• Completion: 2025-06-14
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Egypt