Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial

Melanie A. Van Os; A. Jeanine Van Der Ven; C. Emily Kleinrouweler; Ewoud Schuit; Brenda M. Kazemier; Corine J. Verhoeven; Esteriek De Miranda; Aleid G. Van Wassenaer-Leemhuis; J. Marko Sikkema; Mallory D. Woiski; Patrick M. Bossuyt; Eva Pajkrt; Christianne J.M. De Groot; Ben Willem J. Mol; Monique C. Haak

doi:10.1055/s-0035-1547327

Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial

Melanie A. Van Os^*, A. Jeanine Van Der Ven, C. Emily Kleinrouweler, Ewoud Schuit, Brenda M. Kazemier, Corine J. Verhoeven, Esteriek De Miranda, Aleid G. Van Wassenaer-Leemhuis, J. Marko Sikkema, Mallory D. Woiski, Patrick M. Bossuyt, Eva Pajkrt, Christianne J.M. De Groot, Ben Willem J. Mol, Monique C. Haak

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

28 Citations (Scopus)

Abstract

Objective The objective of this study was to evaluate the effectiveness of vaginal progesterone in reducing adverse neonatal outcome due to preterm birth (PTB) in low-risk pregnant women with a short cervical length (CL). Study Design Women with a singleton pregnancy without a history of PTB underwent CL measurement at 18 to 22 weeks. Women with a CL ≤ 30 mm received vaginal progesterone or placebo. Primary outcome was adverse neonatal outcome, defined as a composite of respiratory distress syndrome, bronchopulmonary dysplasia, intracerebral hemorrhage > grade II, necrotizing enterocolitis > stage 1, proven sepsis, or death before discharge. Secondary outcomes included time to delivery, PTB before 32, 34, and 37 weeks of gestation. Analysis was by intention to treat.

Original language	English
Pages (from-to)	993-1000
Number of pages	8
Journal	American journal of perinatology
Volume	32
Issue number	10
DOIs	https://doi.org/10.1055/s-0035-1547327
Publication status	Published - 4 Mar 2015

Keywords

cervical length
neonatal outcome
preterm birth
progesterone

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10.1055/s-0035-1547327

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Van Os, M. A., Van Der Ven, A. J., Kleinrouweler, C. E., Schuit, E., Kazemier, B. M., Verhoeven, C. J., De Miranda, E., Van Wassenaer-Leemhuis, A. G., Sikkema, J. M., Woiski, M. D., Bossuyt, P. M., Pajkrt, E., De Groot, C. J. M., Mol, B. W. J., & Haak, M. C. (2015). Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial. American journal of perinatology, 32(10), 993-1000. https://doi.org/10.1055/s-0035-1547327

Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial. / Van Os, Melanie A.; Van Der Ven, A. Jeanine; Kleinrouweler, C. Emily et al.
In: American journal of perinatology, Vol. 32, No. 10, 04.03.2015, p. 993-1000.

Research output: Contribution to journal › Article › peer-review

Van Os, MA, Van Der Ven, AJ, Kleinrouweler, CE, Schuit, E, Kazemier, BM, Verhoeven, CJ, De Miranda, E, Van Wassenaer-Leemhuis, AG, Sikkema, JM, Woiski, MD, Bossuyt, PM, Pajkrt, E, De Groot, CJM, Mol, BWJ & Haak, MC 2015, 'Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial', American journal of perinatology, vol. 32, no. 10, pp. 993-1000. https://doi.org/10.1055/s-0035-1547327

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abstract = "Objective The objective of this study was to evaluate the effectiveness of vaginal progesterone in reducing adverse neonatal outcome due to preterm birth (PTB) in low-risk pregnant women with a short cervical length (CL). Study Design Women with a singleton pregnancy without a history of PTB underwent CL measurement at 18 to 22 weeks. Women with a CL ≤ 30 mm received vaginal progesterone or placebo. Primary outcome was adverse neonatal outcome, defined as a composite of respiratory distress syndrome, bronchopulmonary dysplasia, intracerebral hemorrhage > grade II, necrotizing enterocolitis > stage 1, proven sepsis, or death before discharge. Secondary outcomes included time to delivery, PTB before 32, 34, and 37 weeks of gestation. Analysis was by intention to treat.",

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AU - Van Der Ven, A. Jeanine

AU - Kleinrouweler, C. Emily

AU - Schuit, Ewoud

AU - Kazemier, Brenda M.

AU - Verhoeven, Corine J.

AU - De Miranda, Esteriek

AU - Van Wassenaer-Leemhuis, Aleid G.

AU - Sikkema, J. Marko

AU - Woiski, Mallory D.

AU - Bossuyt, Patrick M.

AU - Pajkrt, Eva

AU - De Groot, Christianne J.M.

AU - Mol, Ben Willem J.

AU - Haak, Monique C.

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AB - Objective The objective of this study was to evaluate the effectiveness of vaginal progesterone in reducing adverse neonatal outcome due to preterm birth (PTB) in low-risk pregnant women with a short cervical length (CL). Study Design Women with a singleton pregnancy without a history of PTB underwent CL measurement at 18 to 22 weeks. Women with a CL ≤ 30 mm received vaginal progesterone or placebo. Primary outcome was adverse neonatal outcome, defined as a composite of respiratory distress syndrome, bronchopulmonary dysplasia, intracerebral hemorrhage > grade II, necrotizing enterocolitis > stage 1, proven sepsis, or death before discharge. Secondary outcomes included time to delivery, PTB before 32, 34, and 37 weeks of gestation. Analysis was by intention to treat.

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Preventing Preterm Birth with Progesterone in Women with a Short Cervical Length from a Low-Risk Population: A Multicenter Double-Blind Placebo-Controlled Randomized Trial

Abstract

Keywords

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