drugset / Trial / NCT03863613
Pessary Versus Cerclage With or Without Progesterone in Twins
RandomizedFactorialOpen-labelPrevention
Summary
This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm. Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.
Timeline
- Start
- 2019-03-23
- Primary completion
- 2023-07-08
- Completion
- 2023-07-29
Publications
- 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.
- Dang VQ, He YT, Pham HN, Trieu TT, Bui TQ, Vuong NT, Nguyen LM, Nguyen DT, Le TV, Li W, Le CH, Mol BW, Vuong LN. Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial. BMJ Open. 2020 Jun 16;10(6):e036587. doi: 10.1136/bmjopen-2019-036587.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Progesterone | Other / unclassified | 400 mg | Other |