A Randomized Trial of Progesterone in Women with Recurrent Miscarriages

Research output: Contribution to journalArticlepeer-review

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A Randomized Trial of Progesterone in Women with Recurrent Miscarriages. / Coomarasamy, Aravinthan; Williams, Helen; Truchanowicz, Ewa; Seed, Paul T; Chu, Justin; Eapen, Abey; Small, Rachel; Quenby, Siobhan; Gupta, Pratima; Dawood, Feroza; Koot, Yvonne; Bender Atik, Ruth; Bloemenkamp, KWM; Brady, Rebecca; Briley, Annette; Cavallaro, Rebecca; Cheong, Ying; Ewies, Ayman; Hoek, A; Kaaijk, EM; Koks, CAM; Li, TC; Maclean, M.; Mol, BW; Moore, J; Ross, JA; Sharpe, Lisa; Stewart, Jane; Vaithilingam, Nirmala; Farquharson, RG; Kilby, Mark; Khalaf, Y; Goddijn, M; Regan, Lesley; Rai, Raj.

In: The New England Journal of Medicine, Vol. 373, No. 22, 26.11.2015, p. 2141-2148.

Research output: Contribution to journalArticlepeer-review

Harvard

Coomarasamy, A, Williams, H, Truchanowicz, E, Seed, PT, Chu, J, Eapen, A, Small, R, Quenby, S, Gupta, P, Dawood, F, Koot, Y, Bender Atik, R, Bloemenkamp, KWM, Brady, R, Briley, A, Cavallaro, R, Cheong, Y, Ewies, A, Hoek, A, Kaaijk, EM, Koks, CAM, Li, TC, Maclean, M, Mol, BW, Moore, J, Ross, JA, Sharpe, L, Stewart, J, Vaithilingam, N, Farquharson, RG, Kilby, M, Khalaf, Y, Goddijn, M, Regan, L & Rai, R 2015, 'A Randomized Trial of Progesterone in Women with Recurrent Miscarriages', The New England Journal of Medicine, vol. 373, no. 22, pp. 2141-2148. https://doi.org/10.1056/NEJMoa1504927, https://doi.org/10.1056/NEJMoa1504927

APA

Coomarasamy, A., Williams, H., Truchanowicz, E., Seed, P. T., Chu, J., Eapen, A., Small, R., Quenby, S., Gupta, P., Dawood, F., Koot, Y., Bender Atik, R., Bloemenkamp, KWM., Brady, R., Briley, A., Cavallaro, R., Cheong, Y., Ewies, A., Hoek, A., ... Rai, R. (2015). A Randomized Trial of Progesterone in Women with Recurrent Miscarriages. The New England Journal of Medicine, 373(22), 2141-2148. https://doi.org/10.1056/NEJMoa1504927, https://doi.org/10.1056/NEJMoa1504927

Vancouver

Author

Coomarasamy, Aravinthan ; Williams, Helen ; Truchanowicz, Ewa ; Seed, Paul T ; Chu, Justin ; Eapen, Abey ; Small, Rachel ; Quenby, Siobhan ; Gupta, Pratima ; Dawood, Feroza ; Koot, Yvonne ; Bender Atik, Ruth ; Bloemenkamp, KWM ; Brady, Rebecca ; Briley, Annette ; Cavallaro, Rebecca ; Cheong, Ying ; Ewies, Ayman ; Hoek, A ; Kaaijk, EM ; Koks, CAM ; Li, TC ; Maclean, M. ; Mol, BW ; Moore, J ; Ross, JA ; Sharpe, Lisa ; Stewart, Jane ; Vaithilingam, Nirmala ; Farquharson, RG ; Kilby, Mark ; Khalaf, Y ; Goddijn, M ; Regan, Lesley ; Rai, Raj. / A Randomized Trial of Progesterone in Women with Recurrent Miscarriages. In: The New England Journal of Medicine. 2015 ; Vol. 373, No. 22. pp. 2141-2148.

Bibtex

@article{eb105b332c284c01a51b2c2cbaa2e196,
title = "A Randomized Trial of Progesterone in Women with Recurrent Miscarriages",
abstract = "BACKGROUNDProgesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain.METHODSWe conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation.RESULTSA total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, −4.0 to 9.0). There were no significant between-group differences in the rate of adverse events.CONCLUSIONSProgesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.)",
keywords = "Progesterone, Miscarriage",
author = "Aravinthan Coomarasamy and Helen Williams and Ewa Truchanowicz and Seed, {Paul T} and Justin Chu and Abey Eapen and Rachel Small and Siobhan Quenby and Pratima Gupta and Feroza Dawood and Yvonne Koot and {Bender Atik}, Ruth and KWM Bloemenkamp and Rebecca Brady and Annette Briley and Rebecca Cavallaro and Ying Cheong and Ayman Ewies and A Hoek and EM Kaaijk and CAM Koks and TC Li and M. Maclean and BW Mol and J Moore and JA Ross and Lisa Sharpe and Jane Stewart and Nirmala Vaithilingam and RG Farquharson and Mark Kilby and Y Khalaf and M Goddijn and Lesley Regan and Raj Rai",
year = "2015",
month = nov,
day = "26",
doi = "10.1056/NEJMoa1504927",
language = "English",
volume = "373",
pages = "2141--2148",
journal = "The New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "22",

}

RIS

TY - JOUR

T1 - A Randomized Trial of Progesterone in Women with Recurrent Miscarriages

AU - Coomarasamy, Aravinthan

AU - Williams, Helen

AU - Truchanowicz, Ewa

AU - Seed, Paul T

AU - Chu, Justin

AU - Eapen, Abey

AU - Small, Rachel

AU - Quenby, Siobhan

AU - Gupta, Pratima

AU - Dawood, Feroza

AU - Koot, Yvonne

AU - Bender Atik, Ruth

AU - Bloemenkamp, KWM

AU - Brady, Rebecca

AU - Briley, Annette

AU - Cavallaro, Rebecca

AU - Cheong, Ying

AU - Ewies, Ayman

AU - Hoek, A

AU - Kaaijk, EM

AU - Koks, CAM

AU - Li, TC

AU - Maclean, M.

AU - Mol, BW

AU - Moore, J

AU - Ross, JA

AU - Sharpe, Lisa

AU - Stewart, Jane

AU - Vaithilingam, Nirmala

AU - Farquharson, RG

AU - Kilby, Mark

AU - Khalaf, Y

AU - Goddijn, M

AU - Regan, Lesley

AU - Rai, Raj

PY - 2015/11/26

Y1 - 2015/11/26

N2 - BACKGROUNDProgesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain.METHODSWe conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation.RESULTSA total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, −4.0 to 9.0). There were no significant between-group differences in the rate of adverse events.CONCLUSIONSProgesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.)

AB - BACKGROUNDProgesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain.METHODSWe conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation.RESULTSA total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, −4.0 to 9.0). There were no significant between-group differences in the rate of adverse events.CONCLUSIONSProgesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.)

KW - Progesterone

KW - Miscarriage

UR - http://www.nejm.org/doi/full/10.1056/NEJMoa1504927

U2 - 10.1056/NEJMoa1504927

DO - 10.1056/NEJMoa1504927

M3 - Article

C2 - 26605928

VL - 373

SP - 2141

EP - 2148

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

IS - 22

ER -