Cerclage and Progesterone for Twin Pregnancies

NCT ID: NCT07319715

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2025-06-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

McDonald Cervical Cerclage

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Vaginal Progesterone Therapy (VPT)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

McDonald Cervical Cerclage

Intervention Type: 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.

Vaginal Progesterone Therapy (VPT)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Adel Farag Al Kholy

Professor of Medical Biochemistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Benha University

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Other Identifiers

Rc 4.12.2022

Identifier Type: -

Identifier Source: org_study_id