Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies

NCT06463652 | Recruiting DMC

• 1 other identifier: 08/24/DD-BVMD
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.

Conditions

Preterm Birth; Short Cervix

Keywords

Cerclage; Progesterone; Singleton; Preterm birth

Outcome Measures

Primary Outcomes (1)

• Time from randomization to delivery

  Number of days between randomization and delivery

  From date of randomization until the date of delivery

Secondary Outcomes (37)

• Composite poor neonatal outcomes (major sencondary endpoint)

  From 20 weeks of gestation to 28 days after estimated due date

• Miscarriage <22 weeks (late miscarriage)

  From date of randomization to 22 weeks of gestation

• Gestational age at delivery

  At delivery

• Preterm birth <24 weeks, <28 weeks, <32 weeks, <34 weeks and <37 weeks of gestation

  At delivery

• Spontaneous preterm birth <24 weeks, <28 weeks, <32 weeks, <34 weeks and <37 weeks of gestation

  At delivery

Study Arms (2)

Combined therapy group (cervical cerclage plus vaginal progesterone)

EXPERIMENTAL

Women will be receiving the cervical cerclage according to local protocol within a week after randomization, using the McDonald technique. Within one day after the procedure, they will be receiving 200 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 200mg, Actavis, United Kingdom), once daily at bedtime. Participants will be asked to record their drug application in a patient diary sheet.

Procedure: Cervical cerclage; Drug: Vaginal progesterone

Progesterone only group

ACTIVE COMPARATOR

Women allocated to the progesterone only group will be receiving 200 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 200mg, Actavis, United Kingdom), once daily at bedtime. Participants will be asked to record their drug application in a patient diary sheet.

Drug: Vaginal progesterone

Interventions

Cervical cerclage PROCEDURE

Cervical cerclage using the McDonald technique under anaesthesia.

Combined therapy group (cervical cerclage plus vaginal progesterone)

Vaginal progesterone DRUG

Cyclogest® 200mg, Actavis, United Kingdom, applied once daily at bedtime.

Also known as: Cyclogest® 200 mg

Combined therapy group (cervical cerclage plus vaginal progesterone); Progesterone only group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age ≥18 years
• Singleton pregnancy
• Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7 - 24 0/7 weeks of gestation)
• Not participating in any other study which has intervention on maternity or fetus
• Provision of written informed consent as shown by a signature on the participant consent form.

You may not qualify if:

• Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
• Major congenital abnormalities of the fetus
• Intrauterine fetal demise
• Presence of severe vaginal discharge\*
• Presence of vaginitis or cervicitis\*
• Presence of vaginal bleeding\*
• Placenta previa or vasa previa
• Preterm premature rupture of membranes
• Preterm labor without ruptured membrane at the time of screening
• Suspected chorioamnionitis
• Unable to undergo cerclage
• Cerclage in place
• Allergy to progesterone
• (\*Women with acute cervicitis, vaginitis or severe vaginal discharge are eligible once they have been treated and if they have a CL ≤25 mm between 16 0/7 - 24 0/7 weeks of gestation.)

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical; Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Lan N Vuong, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanh V Le, MD

CONTACT

+84934124733; bsthanh.lv@myduchospital.vn

Lan N Vuong, MD, PhD

CONTACT

+84903008889; drlan@yahoo.com.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 18, 2024
• Study Start: June 26, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)