Comparative Effectiveness of Pessary Placement, Cervical Cerclage, or Expectant Management in Preventing Preterm Delivery in Twin Pregnancies
Abstract
1. Introduction
2. Methods
2.1. Study Design and Population
2.2. Inclusion and Exclusion Criteria
- Confirmed twin pregnancy.
- Availability of cervical assessment data, including cervical length, cervical diameter, and/or presence of funneling.
- Documented cervical management strategy, classified as pessary placement, cervical cerclage, or expectant management.
- Documented gestational age at delivery.
- Negative vaginal and cervical microbiological cultures during pregnancy.
- Normal cervical cytology (Pap smear).
- Positive microbiological cultures suggesting ascending infection.
- Abnormal Pap smear results.
- Major fetal structural or chromosomal abnormalities.
- Twin-to-twin transfusion syndrome requiring fetal intervention.
- Incomplete clinical or outcome data.
2.3. Etiologic Focus
2.4. Data Collection and Variables
2.5. Statistical Analysis
3. Results
3.1. Statistical Analysis of Twin Pregnancies: Gestational Age at Delivery by Intervention Type
3.2. Descriptive Statistics in Twin Pregnancies Stratified by Preterm Birth (<33 Weeks)
3.3. Kaplan–Meier Survival Analysis in Twin Pregnancies: Gestational Age by Intervention
- Pessary group (green line).
- Cerclage group (red line).
- No-intervention group (blue line).
- The no-intervention group had far more preterm deliveries than expected (Observed = 21 vs. Expected = 3.31), contributing the most to the chi-square statistic.
- The cerclage group also delivered earlier than expected but had a smaller sample size.
- The pessary group, on the other hand, showed fewer observed events than expected (Observed = 93 vs. Expected = 114.87), indicating an association with prolonged gestational duration.
3.4. Multivariable Cox Proportional Hazards Model in Twin Pregnancies
4. Discussion
4.1. Comparison to Existing Evidence
4.2. Clinical Implications
4.3. Strengths and Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Roman, A.; Zork, N.; Haeri, S.; Schoen, C.N.; Saccone, G.; Colihan, S.; Zelig, C.; Gimovsky, A.C.; Seligman, N.S.; Zullo, F.; et al. Physical examination–indicated cerclage in twin pregnancy: A randomized controlled trial. Am. J. Obstet. Gynecol. 2020, 223, 902.e1–902.e11. [Google Scholar] [CrossRef] [PubMed]
- D’Antonio, F.; Eltaweel, N.; Prasad, S.; Flacco, M.E.; 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, 20, e1004266. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Zhu, J.; Huang, Y.; Zeng, H.; Huang, J.; Zhang, W. Pregnancy outcomes of twin pregnancies with cervical insufficiency undergoing cervical cerclage. Sci. Rep. 2024, 14, 27414. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Conde-Agudelo, A.; Romero, R.; Nicolaides, K.H. Cervical pessary to prevent preterm birth in asymptomatic high-risk women: A systematic review and meta-analysis. Am. J. Obstet. Gynecol. 2020, 223, 42–65.e2. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Goya, M.; de la Calle, M.; Pratcorona, L.; Merced, C.; Rodó, C.; Muñoz, B.; Juan, M.; Serrano, A.; Llurba, E.; Higueras, T.; et al. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: A multicenter randomized controlled trial (PECEP-Twins). Am. J. Obstet. Gynecol. 2016, 214, 145–152. [Google Scholar] [CrossRef] [PubMed]
- Merced, C.; Goya, M.; Pratcorona, L.; Rodó, C.; Llurba, E.; Higueras, T.; Cabero, L.; Carreras, E.; PECEP-RETARD Trial Group. Cervical pessary for preventing preterm birth in twin pregnancies after threatened preterm labor. Am. J. Obstet. Gynecol. 2019, 221, 55.e1–55.e14. [Google Scholar] [CrossRef] [PubMed]
- He, Y.T.N.; Pham, H.N.H.; Nguyen, T.C.; Bui, T.Q.; Vuong, N.T.; Nguyen, D.T.N.; Le, T.V.; Li, W.; Le, C.H.; Ho, T.M.; et al. 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, 22, e1004526. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Jarde, A.; Lutsiv, O.; Park, C.K.; Barrett, J.; Beyene, J.; Saito, S.; Dodd, J.M.; Shah, P.S.; Cook, J.L.; Biringer, A.B.; et al. Preterm birth prevention in twin pregnancies with progesterone, pessary, or cerclage: A systematic review and meta-analysis. BJOG 2017, 124, 1163–1173. [Google Scholar] [CrossRef] [PubMed]
- Koullali, B.; Westervelt, A.R.; Myers, K.M.; House, M.D. Prevention of preterm birth: Novel interventions for the cervix. Semin. Perinatol. 2017, 41, 505–510. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Kindinger, L.M.; Poon, L.C.; Cacciatore, S.; MacIntyre, D.A.; Fox, N.S.; Schuit, E.; Mol, B.W.; Liem, S.; Lim, A.C.; Serra, V.; et al. The effect of gestational age and cervical length measurements in the prediction of spontaneous preterm birth in twin pregnancies: An individual patient level meta-analysis. BJOG 2016, 123, 877–884. [Google Scholar] [CrossRef] [PubMed]
- Wennerholm, U.B.; Bergman, L.; Kuusela, P.; Ljungström, E.; Möller, A.C.; Hongslo Vala, C.; Ekelund, A.C.; Liljegren, A.; Petzold, M.; Sjögren, P.; et al. Progesterone, cerclage, pessary, or acetylsalicylic acid for prevention of preterm birth in singleton and multifetal pregnancies—A systematic review and meta-analyses. Front. Med. 2023, 10, 1111315, Erratum in Front. Med. 2025, 12, 1561413. https://doi.org/10.3389/fmed.2025.1561413. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Abdel-Aleem, H.; Shaaban, O.M.; Abdel-Aleem, M.A.; Aboelfadle Mohamed, A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst. Rev. 2022, 12, CD014508. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Liem, S.; Schuit, E.; Hegeman, M.; Bais, J.; de Boer, K.; Bloemenkamp, K.; Brons, J.; Duvekot, H.; Bijvank, B.N.; Franssen, M.; et al. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): A multicentre, open-label randomised controlled trial. Lancet 2013, 382, 1341–1349. [Google Scholar] [CrossRef] [PubMed]
- Roman, A.; Suhag, A.; Berghella, V. Cerclage: Indications and Patient Counseling. Clin. Obstet. Gynecol. 2016, 59, 264–269. [Google Scholar] [CrossRef] [PubMed]
- Berghella, V.; Odibo, A.O.; To, M.S.; Rust, O.A.; Althuisius, S.M. Cerclage for short cervix on ultrasonography: Meta-analysis of trials using individual patient-level data. Obstet. Gynecol. 2005, 106, 181–189. [Google Scholar] [CrossRef] [PubMed]
- Saccone, G.; Ciardulli, A.; Xodo, S.; Dugoff, L.; Ludmir, J.; D’Antonio, F.; Boito, S.; Olearo, E.; Votino, C.; Maruotti, G.M.; et al. Cervical pessary for preventing preterm birth in twin pregnancies with short cervical length: A systematic review and meta-analysis. J. Matern.-Fetal Neonatal Med. 2017, 30, 2918–2925. [Google Scholar] [CrossRef] [PubMed]
- Seetho, S.; Kongwattanakul, K.; Saksiriwuttho, P.; Thepsuthammarat, K. Epidemiology and factors associated with preterm births in multiple pregnancy: A retrospective cohort study. BMC Pregnancy Childbirth 2023, 23, 872. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Tsikouras, P.; Anastasopoulos, G.; Maroulis, V.; Bothou, A.; Chalkidou, A.; Deuteraiou, D.; Anthoulaki, X.; Tsatsaris, G.; Bourazan, A.H.; Iatrakis, G.; et al. Comparative Evaluation of Arabin Pessary and Cervical Cerclage for the Prevention of Preterm Labor in Asymptomatic Women with High Risk Factors. Int. J. Environ. Res. Public Health 2018, 15, 791. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]
- Tanaka, K.; Yamada, K.; Matsushima, M.; Izawa, T.; Furukawa, S.; Kobayashi, Y.; Iwashita, M. Prediction of spontaneous preterm delivery in asymptomatic twin pregnancies using cervical length and granulocyte elastase. Taiwan. J. Obstet. Gynecol. 2017, 56, 188–191. [Google Scholar] [CrossRef] [PubMed]
- Costantine, M.M.; Ugwu, L.; Grobman, W.A.; Mercer, B.M.; Tita, A.T.N.; Rouse, D.J.; Sorokin, Y.; Wapner, R.J.; Blackwell, S.C.; Tolosa, J.E.; et al. Cervical length distribution and other sonographic ancillary findings of singleton nulliparous patients at midgestation. Am. J. Obstet. Gynecol. 2021, 225, 181.e1–181.e11. [Google Scholar] [CrossRef] [PubMed] [PubMed Central]



| 0 (Non-Preterm) | 1 (Preterm) | p-Value | |
|---|---|---|---|
| N | 94 | 26 | |
| Cervical Length | 0.161 | ||
| >2.4 cm | 7 (7.4%) | 5 (19.2%) | |
| ≤2.4 cm | 87 (92.6%) | 21 (80.8%) | |
| Cervical Diameter | <0.001 | ||
| >10 mm | 91 (96.8%) | 12 (46.2%) | |
| ≤10 mm | 3 (3.2%) | 14 (53.8%) | |
| Funneling | <0.001 | ||
| NO | 5 (5.3%) | 15 (57.7%) | |
| YES | 89 (94.7%) | 11 (42.3%) | |
| Pessary Use | <0.001 | ||
| NO | 3 (3.2%) | 24 (92.3%) | |
| YES | 91 (96.8%) | 2 (7.7%) | |
| Cerclage Use | 0.111 | ||
| NO | 62 (66.0%) | 22 (84.6%) | |
| YES | 32 (34.0%) | 4 (15.4%) |
| Intervention Group | N | Observed Events | Expected Events | (O–E)2/E | (O–E)2/V |
|---|---|---|---|---|---|
| Cerclage | 6 | 6 | 1.81 | 9.68 | 11.9 |
| No intervention | 21 | 21 | 3.31 | 94.41 | 119.5 |
| Pessary | 93 | 93 | 114.87 | 4.17 | 125.5 |
| Predictor | Hazard Ratio (HR) | 95% CI (Lower–Upper) | p-Value | Significance |
|---|---|---|---|---|
| No Intervention | 2.44 | 0.94–6.33 | 0.067 | marginal |
| Pessary | 0.088 | 0.035–0.220 | <0.001 | *** |
| Cervical Length ≤ 2.4 | 1.21 | 0.65–2.22 | 0.548 | n.s. |
| Diameter ≤ 10 mm | 0.90 | 0.37–2.20 | 0.823 | n.s. |
| Funneling (Yes) | 0.35 | 0.16–0.78 | 0.010 | ** |
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Pagkaki, C.; Kritsotaki, N.; Bothou, A.; Kourti, V.; Tsatsaris, G.; Niesigk, B.; Oikonomou, E.; Machairiotis, N.; Tsikouras, N.; Michalopoulos, S.; et al. Comparative Effectiveness of Pessary Placement, Cervical Cerclage, or Expectant Management in Preventing Preterm Delivery in Twin Pregnancies. J. Pers. Med. 2026, 16, 104. https://doi.org/10.3390/jpm16020104
Pagkaki C, Kritsotaki N, Bothou A, Kourti V, Tsatsaris G, Niesigk B, Oikonomou E, Machairiotis N, Tsikouras N, Michalopoulos S, et al. Comparative Effectiveness of Pessary Placement, Cervical Cerclage, or Expectant Management in Preventing Preterm Delivery in Twin Pregnancies. Journal of Personalized Medicine. 2026; 16(2):104. https://doi.org/10.3390/jpm16020104
Chicago/Turabian StylePagkaki, Christina, Nektaria Kritsotaki, Anastasia Bothou, Vasiliki Kourti, Georgios Tsatsaris, Barbara Niesigk, Efthymios Oikonomou, Nikolaos Machairiotis, Nikolaos Tsikouras, Spyridon Michalopoulos, and et al. 2026. "Comparative Effectiveness of Pessary Placement, Cervical Cerclage, or Expectant Management in Preventing Preterm Delivery in Twin Pregnancies" Journal of Personalized Medicine 16, no. 2: 104. https://doi.org/10.3390/jpm16020104
APA StylePagkaki, C., Kritsotaki, N., Bothou, A., Kourti, V., Tsatsaris, G., Niesigk, B., Oikonomou, E., Machairiotis, N., Tsikouras, N., Michalopoulos, S., Grapsa, A., Gerede, A., Koutlaki, N., Teichmann, A. T., & Tsikouras, P. (2026). Comparative Effectiveness of Pessary Placement, Cervical Cerclage, or Expectant Management in Preventing Preterm Delivery in Twin Pregnancies. Journal of Personalized Medicine, 16(2), 104. https://doi.org/10.3390/jpm16020104

