NCT07372495

Brief Summary

This study aims to compare the effectiveness of cervical cerclage combined with progesterone versus progesterone alone in preventing preterm birth among women with twin pregnancies and a short cervix (cervical length ≤ 30 mm). Participants will be randomly allocated to either the intervention group (cerclage plus progesterone) or the control group (progesterone alone).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026May 2029

First Submitted

Initial submission to the registry

January 9, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

January 9, 2026

Last Update Submit

April 23, 2026

Conditions

Preterm

Keywords

Twin pregnancycervical cerclageProgesterone

Outcome Measures

Primary Outcomes (1)

  • Preterm birth < 28 weeks

    Number of participants with preterm birth before 28 weeks of gestation

    From randomization until 27 6/7 weeks

Secondary Outcomes (37)

  • Gestational age at birth

    At birth

  • Preterm birth < 32 weeks

    From randomization until 31 6/7 weeks

  • Preterm birth < 34 weeks

    From randomization until 33 6/7 weeks

  • Preterm birth < 37 weeks

    From randomization until 36 6/7 weeks

  • Spontaneous preterm birth <28 weeks

    From randomization until 27 6/7 weeks

  • +32 more secondary outcomes

Other Outcomes (26)

  • Number of patients with TTTS after randomization

    From randomization until delivery, assessed up to 28 days after delivery

  • Number of participants diagnosed with TTTS after randomization who received treatment during the study period

    From randomization until delivery, assessed up to 28 days after delivery

  • Number of patients with preeclampsia

    From randomization until delivery, assessed up to 28 days after delivery

  • +23 more other outcomes

Study Arms (2)

Cerclage plus progesterone

EXPERIMENTAL

Participants will receive cervical cerclage according to local protocols within one week after randomization. The procedure will be performed by three senior clinicians experienced in cerclage, using the McDonald technique. In addition, vaginal micronized progesterone will be administered at a total daily dose of 400 mg, given as Utrogestan® 200 mg (Besins Healthcare, France) twice daily, in the morning and at bedtime. Participants will be asked to record their vaginal progesterone application in a patient diary sheet for up to 140 days.

Procedure: Cervical cerclageDrug: Progesterone

Progesterone alone

ACTIVE COMPARATOR

Vaginal micronized progesterone will be administered at a total daily dose of 400 mg, given as Utrogestan® 200 mg (Besins Healthcare, France) twice daily, in the morning and at bedtime. Participants will be asked to record their vaginal progesterone application in a patient diary sheet for up to 140 days

Drug: Progesterone

Interventions

Cervical cerclagePROCEDURE

Participants will receive cervical cerclage according to local protocols within one week after randomization. The procedure will be performed by two to three senior clinicians experienced in cerclage in each center, using the McDonald technique.

Cerclage plus progesterone
ProgesteroneDRUG

Vaginal micronized progesterone will be administered at a total daily dose of 400 mg, given as Utrogestan® 200 mg (Besins Healthcare, France) twice daily, in the morning and at bedtime. Participants will be asked to record their vaginal progesterone application in a patient diary sheet for up to 140 days.

Also known as: Utrogestan 200mg
Cerclage plus progesteroneProgesterone alone

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be biologically female and pregnant
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Maternal age ≥ 18
  • Twin pregnancy
  • Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
  • Gestational age at 16+0- 24+0 weeks

You may not qualify if:

  • A potential paticipant who meets any of the following criteria will be excluded from participation in this trial:
  • Women with twin pregnancy in which one or both fetuses are diagnosed with a major structural or congenital abnormality that is likely to influence the composite adverse neonatal outcome.
  • Women with a monochorionic monoamniotic twin pregnancy
  • Patients have indications for vaginal cerclage: Recurrent late miscarriage (from 14 weeks) or preterm birth occurring two or more times.
  • Women with dilatation of the cervix diagnosed by ultrasound or physical exam
  • Women with overt symptoms of preterm labor at the time of measurement of the short cervix (regular contractions, PPROM, recurrent blood loss).
  • Women with the presence of fever ≥ 38 degrees Celsius.
  • Women with a placenta previa, vasa previa.
  • Uterine malformations: unicornuate uterus, bicornuate uterus, uterine septum, fibroid…
  • Severe maternal conditions (heart failure, chronic kidney disease, systemic lupus erythematosus …)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam

Bac Ninh, 220000, Vietnam

NOT YET RECRUITING

Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam

Bac Ninh, 220000, Vietnam

NOT YET RECRUITING

National Hospital of Obstetrics and Gynecology

Hanoi, 100000, Vietnam

RECRUITING

Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam

Hung Yen, 160000, Vietnam

NOT YET RECRUITING

Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam

Ninh Binh, 430000, Vietnam

NOT YET RECRUITING

Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam

Quang Ninh, 200000, Vietnam

NOT YET RECRUITING

Related Publications (17)

  • Akar B, Ceylan Y, Kahraman A, Kole E, Caliskan E. Centile charts of cervical length in singleton and twin pregnancies between 16 and 24 weeks of gestation. J Turk Ger Gynecol Assoc. 2023 Jun 7;24(2):114-119. doi: 10.4274/jtgga.galenos.2023.2022-7-3. Epub 2023 Mar 31.

    PMID: 36999666RESULT

  • He YTN, Pham HNH, Nguyen TC, Bui TQ, Vuong NT, Nguyen DTN, Le TV, Li W, Le CH, Ho TM, Mol BW, Dang VQ, Vuong LN. Cervical cerclage versus cervical pessary with or without vaginal progesterone for preterm birth prevention in twin pregnancies and a short cervix: A two-by-two factorial randomised clinical trial. PLoS Med. 2025 Feb 21;22(2):e1004526. doi: 10.1371/journal.pmed.1004526. eCollection 2025 Feb.

    PMID: 39982935RESULT

  • van 't Hooft J. A core outcome set for evaluation of interventions to prevent preterm birth: summary for CROWN. BJOG. 2016 Apr;123(5):666. doi: 10.1111/1471-0528.14003. No abstract available.

    PMID: 27149346RESULT

  • van 't Hooft J, Duffy JMN, Daly M, Williamson PR, Meher S, Thom E, Saade GR, Alfirevic Z, Mol BWJ, Khan KS; Global Obstetrics Network (GONet). A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth. Obstet Gynecol. 2016 Jan;127(1):49-58. doi: 10.1097/AOG.0000000000001195.

    PMID: 26646133RESULT

  • D'Antonio F, Eltaweel N, Prasad S, Flacco ME, Manzoli L, Khalil A. Cervical cerclage for prevention of preterm birth and adverse perinatal outcome in twin pregnancies with short cervical length or cervical dilatation: A systematic review and meta-analysis. PLoS Med. 2023 Aug 3;20(8):e1004266. doi: 10.1371/journal.pmed.1004266. eCollection 2023 Aug.

    PMID: 37535682RESULT

  • Wu FT, Chen YY, Chen CP, Sun FJ, Chen CY. Outcomes of ultrasound-indicated cerclage in twin pregnancies with a short cervical length. Taiwan J Obstet Gynecol. 2020 Jul;59(4):508-513. doi: 10.1016/j.tjog.2020.05.007.

    PMID: 32653121RESULT

  • Freegard GD, Donadono V, Impey LWM. Emergency cervical cerclage in twin and singleton pregnancies with 0-mm cervical length or prolapsed membranes. Acta Obstet Gynecol Scand. 2021 Nov;100(11):2003-2008. doi: 10.1111/aogs.14255. Epub 2021 Sep 2.

    PMID: 34476806RESULT

  • Roman A, Zork N, Haeri S, Schoen CN, Saccone G, Colihan S, Zelig C, Gimovsky AC, Seligman NS, Zullo F, Berghella V. Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial. Am J Obstet Gynecol. 2020 Dec;223(6):902.e1-902.e11. doi: 10.1016/j.ajog.2020.06.047. Epub 2020 Jun 25.

    PMID: 32592693RESULT

  • Conde-Agudelo A, Romero R, Nicolaides K, Chaiworapongsa T, O'Brien JM, Cetingoz E, da Fonseca E, Creasy G, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone vs. cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis. Am J Obstet Gynecol. 2013 Jan;208(1):42.e1-42.e18. doi: 10.1016/j.ajog.2012.10.877. Epub 2012 Nov 15.

    PMID: 23157855RESULT

  • Jarde A, Lutsiv O, Park CK, Barrett J, Beyene J, Saito S, Dodd JM, Shah PS, Cook JL, Biringer AB, Giglia L, Han Z, Staub K, Mundle W, Vera C, Sabatino L, Liyanage SK, McDonald SD. Preterm birth prevention in twin pregnancies with progesterone, pessary, or cerclage: a systematic review and meta-analysis. BJOG. 2017 Jul;124(8):1163-1173. doi: 10.1111/1471-0528.14513. Epub 2017 Feb 8.

    PMID: 28176485RESULT

  • D'Antonio F, Berghella V, Di Mascio D, Saccone G, Sileo F, Flacco ME, Odibo AO, Liberati M, Manzoli L, Khalil A. Role of progesterone, cerclage and pessary in preventing preterm birth in twin pregnancies: A systematic review and network meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2021 Jun;261:166-177. doi: 10.1016/j.ejogrb.2021.04.023. Epub 2021 Apr 24.

    PMID: 33946019RESULT

  • Prediction and Prevention of Spontaneous Preterm Birth: ACOG Practice Bulletin, Number 234. Obstet Gynecol. 2021 Aug 1;138(2):e65-e90. doi: 10.1097/AOG.0000000000004479.

    PMID: 34293771RESULT

  • van Gils L, Dutilh R, Denswil N, Roman A, de Boer MA, Pajkrt E, Oudijk MA. The effectiveness of ultrasound-indicated cerclage for the reduction of extreme preterm birth in twin pregnancies with a short cervix: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2025 Jan;7(1):101555. doi: 10.1016/j.ajogmf.2024.101555. Epub 2024 Nov 26.

    PMID: 39603526RESULT

  • Khalil A, Sotiriadis A, Baschat A, Bhide A, Gratacos E, Hecher K, Lewi L, Salomon LJ, Thilaganathan B, Ville Y. ISUOG Practice Guidelines (updated): role of ultrasound in twin pregnancy. Ultrasound Obstet Gynecol. 2025 Feb;65(2):253-276. doi: 10.1002/uog.29166. Epub 2025 Jan 15. No abstract available.

    PMID: 39815396RESULT

  • Dang VQ, Nguyen LK, Pham TD, He YTN, Vu KN, Phan MTN, Le TQ, Le CH, Vuong LN, Mol BW. Pessary Compared With Vaginal Progesterone for the Prevention of Preterm Birth in Women With Twin Pregnancies and Cervical Length Less Than 38 mm: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):459-467. doi: 10.1097/AOG.0000000000003136.

    PMID: 30741812RESULT

  • Litwinska E, Syngelaki A, Cimpoca B, Frei L, Nicolaides KH. Outcome of twin pregnancy with two live fetuses at 11-13 weeks' gestation. Ultrasound Obstet Gynecol. 2020 Jan;55(1):32-38. doi: 10.1002/uog.21892. Epub 2019 Dec 13.

    PMID: 31613412RESULT

  • Osterman M, Hamilton B, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2020. Natl Vital Stat Rep. 2021 Feb;70(17):1-50.

    PMID: 35157571RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, CervicalProgesteroneUtrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, OperativePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Anh D Nguyen, Prof, MD,PhD

    National Hospital of Obstetrics and Gynecology

    STUDY CHAIR

Central Study Contacts

Thu Ha T Nguyen, Assoc. Prof

CONTACT

84965995599dr.hanguyen.nhog@gmail.com

Viet C Dang, MD, MsC

CONTACT

84346150993dangviethmu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and investigators will not be blinded for the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either cerclage plus progesterone or progesterone alone in a 1:1 ratio with a variable block size of 4 or 6.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 28, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

May 30, 2029

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

VN(6)