Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix

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).

Timeline

Start

2026-04-10

Primary completion

2028-12-30

Completion

2029-05-30

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications