Cerclage and Progesterone for Twin Pregnancies

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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Key information

Conditions

Twin Pregnancy With Antenatal Problem

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Benha University

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Jan 6, 2026
Registry last updated: Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed