Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix : The TOPS Randomized Clinical Trial
Importance: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting.
Objective: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix.
Design, Setting, and Participants: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded.
Interventions: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians.
Main Outcome and Measures: The primary outcome was delivery or fetal death prior to 37 weeks.
Results: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32).
Conclusions and Relevance: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality.
Trial Registration: ClinicalTrials.gov Identifier: NCT02901626.
| Errataetall: |
CommentIn: JAMA. 2023 Jul 25;330(4):323-325. - PMID 37490098 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:330 |
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| Enthalten in: |
JAMA - 330(2023), 4 vom: 25. Juli, Seite 340-348 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hoffman, Matthew K [VerfasserIn] |
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| Links: |
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| Themen: |
4G7DS2Q64Y |
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| Anmerkungen: |
Date Completed 28.07.2023 Date Revised 05.03.2024 published: Print ClinicalTrials.gov: NCT02901626 CommentIn: JAMA. 2023 Jul 25;330(4):323-325. - PMID 37490098 Citation Status MEDLINE |
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| doi: |
10.1001/jama.2023.10812 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Hoffman, Matthew K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix |b The TOPS Randomized Clinical Trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 28.07.2023 | ||
| 500 | |a Date Revised 05.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02901626 | ||
| 500 | |a CommentIn: JAMA. 2023 Jul 25;330(4):323-325. - PMID 37490098 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting | ||
| 520 | |a Objective: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix | ||
| 520 | |a Design, Setting, and Participants: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded | ||
| 520 | |a Interventions: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians | ||
| 520 | |a Main Outcome and Measures: The primary outcome was delivery or fetal death prior to 37 weeks | ||
| 520 | |a Results: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32) | ||
| 520 | |a Conclusions and Relevance: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifier: NCT02901626 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 7 | |a Progesterone |2 NLM | |
| 650 | 7 | |a 4G7DS2Q64Y |2 NLM | |
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