17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies

Arianne C. Lim; Ewoud Schuit; Kitty Bloemenkamp; Rob E. Bernardus; Johannes J. Duvekot; Jan Jaap H. M. Erwich; Jim van Eyck; Rolf H. H. Groenwold; Tom H. M. Hasaart; Piet Hummel; Michael M. Kars; Anneke Kwee; Charlotte M. van Oirschot; Marielle G. van Pampus; Dimitri Papatsonis; Martina M. Porath; Marc E. Spaanderman; Christine Willekes; Janine Wilpshaar; Ben W. J. Mol; Hein W. Bruinse

doi:10.1097/AOG.0b013e31822ad6aa

17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies

Arianne C. Lim^*, Ewoud Schuit, Kitty Bloemenkamp, Rob E. Bernardus, Johannes J. Duvekot, Jan Jaap H. M. Erwich, Jim van Eyck, Rolf H. H. Groenwold, Tom H. M. Hasaart, Piet Hummel, Michael M. Kars, Anneke Kwee, Charlotte M. van Oirschot, Marielle G. van Pampus, Dimitri Papatsonis, Martina M. Porath, Marc E. Spaanderman, Christine Willekes, Janine Wilpshaar, Ben W. J. MolHein W. Bruinse

^*Corresponding author voor dit werk

Onderzoeksoutput › Academic › peer review

77 Citaten (Scopus)

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OBJECTIVE: To estimate whether administration of 17 alpha-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.

METHODS: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17 alpha-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation.

RESULTS: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17 alpha-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17 alpha-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P =.32). Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17 alpha-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28).

CONCLUSION: 17 alpha-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies.

Originele taal-2	English
Pagina's (van-tot)	513-520
Aantal pagina's	8
Tijdschrift	Obstetrics and Gynecology
Volume	118
Nummer van het tijdschrift	3
DOI's	https://doi.org/10.1097/AOG.0b013e31822ad6aa
Status	Published - sep.-2011

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Lim, A. C., Schuit, E., Bloemenkamp, K., Bernardus, R. E., Duvekot, J. J., Erwich, J. J. H. M., van Eyck, J., Groenwold, R. H. H., Hasaart, T. H. M., Hummel, P., Kars, M. M., Kwee, A., van Oirschot, C. M., van Pampus, M. G., Papatsonis, D., Porath, M. M., Spaanderman, M. E., Willekes, C., Wilpshaar, J., ... Bruinse, H. W. (2011). 17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies. Obstetrics and Gynecology, 118(3), 513-520. https://doi.org/10.1097/AOG.0b013e31822ad6aa

@article{023c1247556249b7a8171eaa991cf60c,

title = "17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies",

abstract = "OBJECTIVE: To estimate whether administration of 17 alpha-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.METHODS: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17 alpha-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation.RESULTS: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17 alpha-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17 alpha-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P =.32). Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17 alpha-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28).CONCLUSION: 17 alpha-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies.",

keywords = "PRETERM BIRTH, DOUBLE-BLIND, PROGESTERONE, DELIVERY, TWINS, MYOMETRIUM, PREDICTION, TRIAL, WOMEN, RISK",

author = "Lim, {Arianne C.} and Ewoud Schuit and Kitty Bloemenkamp and Bernardus, {Rob E.} and Duvekot, {Johannes J.} and Erwich, {Jan Jaap H. M.} and {van Eyck}, Jim and Groenwold, {Rolf H. H.} and Hasaart, {Tom H. M.} and Piet Hummel and Kars, {Michael M.} and Anneke Kwee and {van Oirschot}, {Charlotte M.} and {van Pampus}, {Marielle G.} and Dimitri Papatsonis and Porath, {Martina M.} and Spaanderman, {Marc E.} and Christine Willekes and Janine Wilpshaar and Mol, {Ben W. J.} and Bruinse, {Hein W.}",

year = "2011",

month = sep,

doi = "10.1097/AOG.0b013e31822ad6aa",

language = "English",

volume = "118",

pages = "513--520",

journal = "Obstetrics and Gynecology",

issn = "0029-7844",

publisher = "LIPPINCOTT WILLIAMS & WILKINS",

number = "3",

}

Lim, AC, Schuit, E, Bloemenkamp, K, Bernardus, RE, Duvekot, JJ, Erwich, JJHM, van Eyck, J, Groenwold, RHH, Hasaart, THM, Hummel, P, Kars, MM, Kwee, A, van Oirschot, CM, van Pampus, MG, Papatsonis, D, Porath, MM, Spaanderman, ME, Willekes, C, Wilpshaar, J, Mol, BWJ & Bruinse, HW 2011, '17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies', Obstetrics and Gynecology, vol. 118, nr. 3, blz. 513-520. https://doi.org/10.1097/AOG.0b013e31822ad6aa

TY - JOUR

T1 - 17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies

AU - Lim, Arianne C.

AU - Schuit, Ewoud

AU - Bloemenkamp, Kitty

AU - Bernardus, Rob E.

AU - Duvekot, Johannes J.

AU - Erwich, Jan Jaap H. M.

AU - van Eyck, Jim

AU - Groenwold, Rolf H. H.

AU - Hasaart, Tom H. M.

AU - Hummel, Piet

AU - Kars, Michael M.

AU - Kwee, Anneke

AU - van Oirschot, Charlotte M.

AU - van Pampus, Marielle G.

AU - Papatsonis, Dimitri

AU - Porath, Martina M.

AU - Spaanderman, Marc E.

AU - Willekes, Christine

AU - Wilpshaar, Janine

AU - Mol, Ben W. J.

AU - Bruinse, Hein W.

PY - 2011/9

Y1 - 2011/9

N2 - OBJECTIVE: To estimate whether administration of 17 alpha-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.METHODS: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17 alpha-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation.RESULTS: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17 alpha-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17 alpha-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P =.32). Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17 alpha-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28).CONCLUSION: 17 alpha-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies.

AB - OBJECTIVE: To estimate whether administration of 17 alpha-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.METHODS: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17 alpha-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation.RESULTS: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17 alpha-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17 alpha-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P =.32). Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17 alpha-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28).CONCLUSION: 17 alpha-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies.

KW - PRETERM BIRTH

KW - DOUBLE-BLIND

KW - PROGESTERONE

KW - DELIVERY

KW - TWINS

KW - MYOMETRIUM

KW - PREDICTION

KW - TRIAL

KW - WOMEN

KW - RISK

U2 - 10.1097/AOG.0b013e31822ad6aa

DO - 10.1097/AOG.0b013e31822ad6aa

M3 - Article

SN - 0029-7844

VL - 118

SP - 513

EP - 520

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

IS - 3

ER -

17 alpha-Hydroxyprogesterone Caproate for the Prevention of Adverse Neonatal Outcome in Multiple Pregnancies

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