Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data

Roberto Romero; Kypros Nicolaides; Agustin Conde-Agudelo; Ann Tabor; John M O'Brien; Elcin Cetingoz; Eduardo Da Fonseca; George W Creasy; Katharina Klein; Line Rode; Priya Soma-Pillay; Shalini Fusey; Cetin Cam; Zarko Alfirevic; Sonia S Hassan

doi:10.1016/j.ajog.2011.12.003

Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data

Roberto Romero, Kypros Nicolaides, Agustin Conde-Agudelo, Ann Tabor, John M O'Brien, Elcin Cetingoz, Eduardo Da Fonseca, George W Creasy, Katharina Klein, Line Rode, Priya Soma-Pillay, Shalini Fusey, Cetin Cam, Zarko Alfirevic, Sonia S Hassan

359 Citations (Scopus)

Abstract

Objective: To determine whether the use of vaginal progesterone in asymptomatic women with a sonographic short cervix (≤25 mm) in the midtrimester reduces the risk of preterm birth and improves neonatal morbidity and mortality. Study Design: Individual patient data metaanalysis of randomized controlled trials. Results: Five trials of high quality were included with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth <33 weeks (relative risk [RR], 0.58; 95% confidence interval [CI], 0.420.80), <35 weeks (RR, 0.69; 95% CI, 0.550.88), and <28 weeks (RR, 0.50; 95% CI, 0.300.81); respiratory distress syndrome (RR, 0.48; 95% CI, 0.300.76); composite neonatal morbidity and mortality (RR, 0.57; 95% CI, 0.400.81); birthweight <1500 g (RR, 0.55; 95% CI, 0.380.80); admission to neonatal intensive care unit (RR, 0.75; 95% CI, 0.590.94); and requirement for mechanical ventilation (RR, 0.66; 95% CI, 0.440.98). There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies. Conclusion: Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.

Original language	English
Journal	American Journal of Obstetrics and Gynecology
Volume	206
Issue number	2
Pages (from-to)	124.e1-19
ISSN	0002-9378
DOIs	https://doi.org/10.1016/j.ajog.2011.12.003
Publication status	Published - Feb 2012

Keywords

Administration, Intravaginal
Female
Humans
Pregnancy
Pregnancy Trimester, Second
Premature Birth
Progesterone
Progestins
Risk
Treatment Outcome

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Romero, R., Nicolaides, K., Conde-Agudelo, A., Tabor, A., O'Brien, J. M., Cetingoz, E., Da Fonseca, E., Creasy, G. W., Klein, K., Rode, L., Soma-Pillay, P., Fusey, S., Cam, C., Alfirevic, Z., & Hassan, S. S. (2012). Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. American Journal of Obstetrics and Gynecology, 206(2), 124.e1-19. https://doi.org/10.1016/j.ajog.2011.12.003

Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity : a systematic review and metaanalysis of individual patient data. / Romero, Roberto; Nicolaides, Kypros; Conde-Agudelo, Agustin et al.

In: American Journal of Obstetrics and Gynecology, Vol. 206, No. 2, 02.2012, p. 124.e1-19.

Research output: Contribution to journal › Journal article › Research › peer-review

Romero, R, Nicolaides, K, Conde-Agudelo, A, Tabor, A, O'Brien, JM, Cetingoz, E, Da Fonseca, E, Creasy, GW, Klein, K, Rode, L, Soma-Pillay, P, Fusey, S, Cam, C, Alfirevic, Z & Hassan, SS 2012, 'Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data', American Journal of Obstetrics and Gynecology, vol. 206, no. 2, pp. 124.e1-19. https://doi.org/10.1016/j.ajog.2011.12.003

Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. American Journal of Obstetrics and Gynecology. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003

Romero, Roberto ; Nicolaides, Kypros ; Conde-Agudelo, Agustin et al. / Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity : a systematic review and metaanalysis of individual patient data. In: American Journal of Obstetrics and Gynecology. 2012 ; Vol. 206, No. 2. pp. 124.e1-19.

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abstract = "Objective: To determine whether the use of vaginal progesterone in asymptomatic women with a sonographic short cervix (≤25 mm) in the midtrimester reduces the risk of preterm birth and improves neonatal morbidity and mortality. Study Design: Individual patient data metaanalysis of randomized controlled trials. Results: Five trials of high quality were included with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth <33 weeks (relative risk [RR], 0.58; 95% confidence interval [CI], 0.420.80), <35 weeks (RR, 0.69; 95% CI, 0.550.88), and <28 weeks (RR, 0.50; 95% CI, 0.300.81); respiratory distress syndrome (RR, 0.48; 95% CI, 0.300.76); composite neonatal morbidity and mortality (RR, 0.57; 95% CI, 0.400.81); birthweight <1500 g (RR, 0.55; 95% CI, 0.380.80); admission to neonatal intensive care unit (RR, 0.75; 95% CI, 0.590.94); and requirement for mechanical ventilation (RR, 0.66; 95% CI, 0.440.98). There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies. Conclusion: Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.",

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T1 - Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity

T2 - a systematic review and metaanalysis of individual patient data

AU - Romero, Roberto

AU - Nicolaides, Kypros

AU - Conde-Agudelo, Agustin

AU - Tabor, Ann

AU - O'Brien, John M

AU - Cetingoz, Elcin

AU - Da Fonseca, Eduardo

AU - Creasy, George W

AU - Klein, Katharina

AU - Rode, Line

AU - Soma-Pillay, Priya

AU - Fusey, Shalini

AU - Cam, Cetin

AU - Alfirevic, Zarko

AU - Hassan, Sonia S

PY - 2012/2

Y1 - 2012/2

N2 - Objective: To determine whether the use of vaginal progesterone in asymptomatic women with a sonographic short cervix (≤25 mm) in the midtrimester reduces the risk of preterm birth and improves neonatal morbidity and mortality. Study Design: Individual patient data metaanalysis of randomized controlled trials. Results: Five trials of high quality were included with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth <33 weeks (relative risk [RR], 0.58; 95% confidence interval [CI], 0.420.80), <35 weeks (RR, 0.69; 95% CI, 0.550.88), and <28 weeks (RR, 0.50; 95% CI, 0.300.81); respiratory distress syndrome (RR, 0.48; 95% CI, 0.300.76); composite neonatal morbidity and mortality (RR, 0.57; 95% CI, 0.400.81); birthweight <1500 g (RR, 0.55; 95% CI, 0.380.80); admission to neonatal intensive care unit (RR, 0.75; 95% CI, 0.590.94); and requirement for mechanical ventilation (RR, 0.66; 95% CI, 0.440.98). There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies. Conclusion: Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.

AB - Objective: To determine whether the use of vaginal progesterone in asymptomatic women with a sonographic short cervix (≤25 mm) in the midtrimester reduces the risk of preterm birth and improves neonatal morbidity and mortality. Study Design: Individual patient data metaanalysis of randomized controlled trials. Results: Five trials of high quality were included with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth <33 weeks (relative risk [RR], 0.58; 95% confidence interval [CI], 0.420.80), <35 weeks (RR, 0.69; 95% CI, 0.550.88), and <28 weeks (RR, 0.50; 95% CI, 0.300.81); respiratory distress syndrome (RR, 0.48; 95% CI, 0.300.76); composite neonatal morbidity and mortality (RR, 0.57; 95% CI, 0.400.81); birthweight <1500 g (RR, 0.55; 95% CI, 0.380.80); admission to neonatal intensive care unit (RR, 0.75; 95% CI, 0.590.94); and requirement for mechanical ventilation (RR, 0.66; 95% CI, 0.440.98). There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies. Conclusion: Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.

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KW - Humans

KW - Pregnancy

KW - Pregnancy Trimester, Second

KW - Premature Birth

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KW - Progestins

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KW - Treatment Outcome

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