Cerclage and Progesterone for Twin Pregnancies

Benha University

Status and phase: Completed; Phase 2

Conditions: Twin Pregnancy With Antenatal Problem

Treatments: Procedure: McDonald Cervical Cerclage; Drug: Vaginal Progesterone Therapy (VPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07319715

Rc 4.12.2022

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups

Cervical Cerclage (CC)

Active Comparator group

Description:

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.

Treatment:

Procedure: McDonald Cervical Cerclage

Vaginal Progesterone Therapy (VPT)

Active Comparator group

Description:

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.

Treatment:

Drug: Vaginal Progesterone Therapy (VPT)

Combined Therapy (CC/VPT)

Active Comparator group

Description:

Participants receive both the surgical Cervical Cerclage procedure and the daily Vaginal Progesterone inserts as described in the individual arms above.

Treatment:

Drug: Vaginal Progesterone Therapy (VPT)

Procedure: McDonald Cervical Cerclage