Prevention of preterm birth with pessary in twins (PoPPT) : a randomized controlled trial
Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd..
OBJECTIVE: To evaluate whether cervical pessary placement prevents preterm birth (PTB) in twin gestations with a short mid-trimester cervical length (CL) on transvaginal sonography (TVS).
METHODS: This was a multicenter randomized controlled trial of asymptomatic women with a twin gestation and a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks' gestation. TVS-CL was measured at the time of the fetal anatomy scan at 18 + 0 to 23 + 6 weeks and at subsequent scheduled ultrasound scans prior to 28 weeks. Women with a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks were randomized to receive either the Bioteque™ cup cervical pessary or no pessary. Randomization was stratified by gestational age, study site and chorionicity. Women with a monoamniotic twin gestation, twin-twin transfusion syndrome, early selective intrauterine growth restriction or placenta previa were excluded. Cervical pessaries were inserted by maternal-fetal medicine staff centrally trained in proper placement. No other treatment for women with a short cervix was recommended. Primary outcome was PTB < 34 weeks. The trial was stopped early before complete enrollment.
RESULTS: A total of 421 women with a twin gestation were screened for TVS-CL, and 85 (20%) had a TVS-CL of ≤ 30 mm. Of these, 80 (94%) met the eligibility criteria and 46 (58%) of the eligible women agreed to randomization. Twenty-three (50%) women were randomized to pessary placement and 23 (50%) to no pessary. Demographic characteristics, including median gestational age (21.0 vs 21.2 weeks; P = 0.69) and TVS-CL (16.7 vs 22.9 mm; P = 0.45) at randomization, were similar between the pessary and no-pessary groups, except for level of education (more than high school education: 48% vs 78%, respectively; P = 0.03) and proportion of spontaneous conceptions (83% vs 43%, respectively; P = 0.01). There were no significant differences between the pessary and no-pessary groups in rate of primary outcome, PTB < 34 weeks (39% vs 35%; relative risk, 1.13 (95% CI, 0.53-2.40)), as well as other outcomes, including PTB < 37 weeks and < 28 weeks, gestational age at delivery, birth weight and composite adverse neonatal outcome.
CONCLUSION: Treatment with cervical pessary was not associated with the prevention of PTB in women with a twin gestation and a mid-trimester TVS-CL of ≤ 30 mm in this small underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.
| Errataetall: |
CommentIn: Ultrasound Obstet Gynecol. 2017 Sep;50(3):409-410. - PMID 28938060 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:49 |
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| Enthalten in: |
Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology - 49(2017), 5 vom: 07. Mai, Seite 567-572 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Berghella, V [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 10.10.2017 Date Revised 17.11.2017 published: Print CommentIn: Ultrasound Obstet Gynecol. 2017 Sep;50(3):409-410. - PMID 28938060 Citation Status MEDLINE |
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| doi: |
10.1002/uog.17430 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a CommentIn: Ultrasound Obstet Gynecol. 2017 Sep;50(3):409-410. - PMID 28938060 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. | ||
| 520 | |a OBJECTIVE: To evaluate whether cervical pessary placement prevents preterm birth (PTB) in twin gestations with a short mid-trimester cervical length (CL) on transvaginal sonography (TVS) | ||
| 520 | |a METHODS: This was a multicenter randomized controlled trial of asymptomatic women with a twin gestation and a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks' gestation. TVS-CL was measured at the time of the fetal anatomy scan at 18 + 0 to 23 + 6 weeks and at subsequent scheduled ultrasound scans prior to 28 weeks. Women with a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks were randomized to receive either the Bioteque™ cup cervical pessary or no pessary. Randomization was stratified by gestational age, study site and chorionicity. Women with a monoamniotic twin gestation, twin-twin transfusion syndrome, early selective intrauterine growth restriction or placenta previa were excluded. Cervical pessaries were inserted by maternal-fetal medicine staff centrally trained in proper placement. No other treatment for women with a short cervix was recommended. Primary outcome was PTB < 34 weeks. The trial was stopped early before complete enrollment | ||
| 520 | |a RESULTS: A total of 421 women with a twin gestation were screened for TVS-CL, and 85 (20%) had a TVS-CL of ≤ 30 mm. Of these, 80 (94%) met the eligibility criteria and 46 (58%) of the eligible women agreed to randomization. Twenty-three (50%) women were randomized to pessary placement and 23 (50%) to no pessary. Demographic characteristics, including median gestational age (21.0 vs 21.2 weeks; P = 0.69) and TVS-CL (16.7 vs 22.9 mm; P = 0.45) at randomization, were similar between the pessary and no-pessary groups, except for level of education (more than high school education: 48% vs 78%, respectively; P = 0.03) and proportion of spontaneous conceptions (83% vs 43%, respectively; P = 0.01). There were no significant differences between the pessary and no-pessary groups in rate of primary outcome, PTB < 34 weeks (39% vs 35%; relative risk, 1.13 (95% CI, 0.53-2.40)), as well as other outcomes, including PTB < 37 weeks and < 28 weeks, gestational age at delivery, birth weight and composite adverse neonatal outcome | ||
| 520 | |a CONCLUSION: Treatment with cervical pessary was not associated with the prevention of PTB in women with a twin gestation and a mid-trimester TVS-CL of ≤ 30 mm in this small underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd | ||
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| 650 | 4 | |a randomized controlled trial | |
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