Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial]
Objective: Cervical insufficiency accounts for 8 % of preterm births. Pessary and cerclage are considered preventive approaches for preterm birth. These interventions were compared in terms of reducing the prematurity rate in women with previous preterm birth, due to cervical insufficiency or due to...
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Elsevier
2024-12-01
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| Series: | European Journal of Obstetrics & Gynecology and Reproductive Biology: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S259016132400067X |
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| author | Andrea Gascón Nerea Maiz Maia Brik Manel Mendoza Ester del Barco Elena Carreras Maria Goya |
| author_facet | Andrea Gascón Nerea Maiz Maia Brik Manel Mendoza Ester del Barco Elena Carreras Maria Goya |
| author_sort | Andrea Gascón |
| collection | DOAJ |
| description | Objective: Cervical insufficiency accounts for 8 % of preterm births. Pessary and cerclage are considered preventive approaches for preterm birth. These interventions were compared in terms of reducing the prematurity rate in women with previous preterm birth, due to cervical insufficiency or due to having a short cervix in their current pregnancy. Methods: This was a prospective, multicentric, open-label, randomised, pilot, controlled trial. Participants were women with singleton pregnancies who had previous preterm birth caused by cervical insufficiency or previous preterm birth and a short cervix [≤ 25 mm] in their current pregnancy. Women were randomised [1:1] to either cerclage or pessary. The primary outcome was to assess the feasibility of a trial on cervical pessary vs. cerclage to prevent preterm birth before 34 weeks in women with cervical insufficiency. As a secondary outcome, we studied the morbidity rate of the pessary versus the cerclage in women with cervical insufficiency and assessed the financial impact of using both devices in these women. The sample size was calculated based on the estimated population that we could potentially recruit: 60 women, 30 for each group, to ascertain whether the rate of preterm birth < 34 weeks of gestation may be reduced from 34 % to at least 27 % in the pessary group, as in the results obtained with the cerclage. Results: No significant differences in preterm birth < 34 weeks of gestation were observed in our study, although it was underpowered to detect these differences [the relative risk [RR] of PB < 34 weeks of gestation was 0.8 [95 % CI: 0.31–2.09, p = 0.888]. The rates of obstetric and perinatal complications were similar for both devices [15 cases in both groups, 50 % of cases [RR; 0.6–1.68; p = 1]. Cervical pessary had fewer secondary effects than the cerclage [less bleeding at insertion in the pessary group compared with cerclage, 1 case vs 14 cases, p < 0.001; less pain at removal in the pessary group compared with cerclage, 14 vs 22 cases. p = 0.042 and less bleeding, 2 cases vs. 10 cases, p = 0.027]. Conclusions: Pessary does not seem less effective than cerclage, although these findings need to be confirmed in a larger randomised controlled trial. Pessary had fewer secondary effects than cerclage both at insertion and removal. Sinopsis: Cervical pessary does not seem to be less effective than cerclage. Cervical pessary had fewer secondary effects than cerclage. |
| format | Article |
| id | doaj-art-49136c7b759a4244b3c550c8506a4d4e |
| institution | OA Journals |
| issn | 2590-1613 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | European Journal of Obstetrics & Gynecology and Reproductive Biology: X |
| spelling | doaj-art-49136c7b759a4244b3c550c8506a4d4e2025-08-20T01:55:46ZengElsevierEuropean Journal of Obstetrics & Gynecology and Reproductive Biology: X2590-16132024-12-012410034710.1016/j.eurox.2024.100347Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial]Andrea Gascón0Nerea Maiz1Maia Brik2Manel Mendoza3Ester del Barco4Elena Carreras5Maria Goya6Maternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainMaternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainDepartment of Obstetrics, Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, SpainMaternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainMaternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainMaternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Barcelona, SpainMaternal Fetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain; Correspondence to: Maternal Foetal Medicine Unit, Department of Obstetrics, Hospital Universitari Vall d′Hebron, Universitat Autònoma de Barcelona, Passeig de la Vall d′Hebron, 119-129 08036 Barcelona, Spain.Objective: Cervical insufficiency accounts for 8 % of preterm births. Pessary and cerclage are considered preventive approaches for preterm birth. These interventions were compared in terms of reducing the prematurity rate in women with previous preterm birth, due to cervical insufficiency or due to having a short cervix in their current pregnancy. Methods: This was a prospective, multicentric, open-label, randomised, pilot, controlled trial. Participants were women with singleton pregnancies who had previous preterm birth caused by cervical insufficiency or previous preterm birth and a short cervix [≤ 25 mm] in their current pregnancy. Women were randomised [1:1] to either cerclage or pessary. The primary outcome was to assess the feasibility of a trial on cervical pessary vs. cerclage to prevent preterm birth before 34 weeks in women with cervical insufficiency. As a secondary outcome, we studied the morbidity rate of the pessary versus the cerclage in women with cervical insufficiency and assessed the financial impact of using both devices in these women. The sample size was calculated based on the estimated population that we could potentially recruit: 60 women, 30 for each group, to ascertain whether the rate of preterm birth < 34 weeks of gestation may be reduced from 34 % to at least 27 % in the pessary group, as in the results obtained with the cerclage. Results: No significant differences in preterm birth < 34 weeks of gestation were observed in our study, although it was underpowered to detect these differences [the relative risk [RR] of PB < 34 weeks of gestation was 0.8 [95 % CI: 0.31–2.09, p = 0.888]. The rates of obstetric and perinatal complications were similar for both devices [15 cases in both groups, 50 % of cases [RR; 0.6–1.68; p = 1]. Cervical pessary had fewer secondary effects than the cerclage [less bleeding at insertion in the pessary group compared with cerclage, 1 case vs 14 cases, p < 0.001; less pain at removal in the pessary group compared with cerclage, 14 vs 22 cases. p = 0.042 and less bleeding, 2 cases vs. 10 cases, p = 0.027]. Conclusions: Pessary does not seem less effective than cerclage, although these findings need to be confirmed in a larger randomised controlled trial. Pessary had fewer secondary effects than cerclage both at insertion and removal. Sinopsis: Cervical pessary does not seem to be less effective than cerclage. Cervical pessary had fewer secondary effects than cerclage.http://www.sciencedirect.com/science/article/pii/S259016132400067XCervical insufficiencyPreterm birthCervical pessaryCervical cerclage |
| spellingShingle | Andrea Gascón Nerea Maiz Maia Brik Manel Mendoza Ester del Barco Elena Carreras Maria Goya Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial] European Journal of Obstetrics & Gynecology and Reproductive Biology: X Cervical insufficiency Preterm birth Cervical pessary Cervical cerclage |
| title | Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial] |
| title_full | Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial] |
| title_fullStr | Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial] |
| title_full_unstemmed | Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial] |
| title_short | Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial] |
| title_sort | cervical cerclage vs cervical pessary in women with cervical insufficiency a multicentric open label randomised controlled pilot trial the cepeic trial |
| topic | Cervical insufficiency Preterm birth Cervical pessary Cervical cerclage |
| url | http://www.sciencedirect.com/science/article/pii/S259016132400067X |
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