Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial

Laura Visser; Marjon A. de Boer; Christianne J. M. de Groot; Tobias A. J. Nijman; Marieke A. C. Hemels; Kitty W. M. Bloemenkamp; Judith E. Bosmans; Marjolein Kok; Judith O. van Laar; Marieke Sueters; Hubertina Scheepers; Joris van Drongelen; Maureen T. M. Franssen; J. Marko Sikkema; Hans J. J. Duvekot; Mireille N. Bekker; Joris A. M. van der Post; Christiana Naaktgeboren; Ben W. J. Mol; Martijn A. Oudijk

doi:10.1186/s12884-017-1338-0

Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial

Laura Visser, Marjon A. de Boer, Christianne J. M. de Groot, Tobias A. J. Nijman, Marieke A. C. Hemels, Kitty W. M. Bloemenkamp, Judith E. Bosmans, Marjolein Kok, Judith O. van Laar, Marieke Sueters, Hubertina Scheepers, Joris van Drongelen, Maureen T. M. Franssen, J. Marko Sikkema, Hans J. J. Duvekot, Mireille N. Bekker, Joris A. M. van der Post, Christiana Naaktgeboren, Ben W. J. Mol, Martijn A. Oudijk^*

^*Corresponding author for this work

Reproductive Origins of Adult Health and Disease (ROAHD)

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

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Abstract

Background: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-) effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial.

Methods/design: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) <37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost- effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo.

Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth.

Original language	English
Article number	223
Number of pages	7
Journal	BMC Pregnancy and Childbirth
Volume	17
DOIs	https://doi.org/10.1186/s12884-017-1338-0
Publication status	Published - 14-Jul-2017

Keywords

Pregnancy
'Spontaneous recurrent preterm birth'
SPTB
Preterm birth
Preterm labour
PTB
Prevention
Reduction
Aspirin
Acetylsalicylic acid
ASA
LOW-BIRTH-WEIGHT
TASK-FORCE
PHYSIOLOGICAL TRANSFORMATION
PREGNANCY COMPLICATIONS
SPIRAL ARTERIES
META-ANALYSIS
DELIVERY
MEMBRANES
PREECLAMPSIA
METAANALYSIS

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Visser, L., de Boer, M. A., de Groot, C. J. M., Nijman, T. A. J., Hemels, M. A. C., Bloemenkamp, K. W. M., Bosmans, J. E., Kok, M., van Laar, J. O., Sueters, M., Scheepers, H., van Drongelen, J., Franssen, M. T. M., Sikkema, J. M., Duvekot, H. J. J., Bekker, M. N., van der Post, J. A. M., Naaktgeboren, C., Mol, B. W. J., & Oudijk, M. A. (2017). Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial. BMC Pregnancy and Childbirth, 17, Article 223. https://doi.org/10.1186/s12884-017-1338-0

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title = "Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial",

abstract = "Background: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-) effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial.Methods/design: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) <37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost- effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo.Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth.",

keywords = "Pregnancy, 'Spontaneous recurrent preterm birth', SPTB, Preterm birth, Preterm labour, PTB, Prevention, Reduction, Aspirin, Acetylsalicylic acid, ASA, LOW-BIRTH-WEIGHT, TASK-FORCE, PHYSIOLOGICAL TRANSFORMATION, PREGNANCY COMPLICATIONS, SPIRAL ARTERIES, META-ANALYSIS, DELIVERY, MEMBRANES, PREECLAMPSIA, METAANALYSIS",

author = "Laura Visser and {de Boer}, {Marjon A.} and {de Groot}, {Christianne J. M.} and Nijman, {Tobias A. J.} and Hemels, {Marieke A. C.} and Bloemenkamp, {Kitty W. M.} and Bosmans, {Judith E.} and Marjolein Kok and {van Laar}, {Judith O.} and Marieke Sueters and Hubertina Scheepers and {van Drongelen}, Joris and Franssen, {Maureen T. M.} and Sikkema, {J. Marko} and Duvekot, {Hans J. J.} and Bekker, {Mireille N.} and {van der Post}, {Joris A. M.} and Christiana Naaktgeboren and Mol, {Ben W. J.} and Oudijk, {Martijn A.}",

year = "2017",

month = jul,

day = "14",

doi = "10.1186/s12884-017-1338-0",

language = "English",

volume = "17",

journal = "BMC Pregnancy and Childbirth",

issn = "1471-2393",

publisher = "BMC",

}

Visser, L, de Boer, MA, de Groot, CJM, Nijman, TAJ, Hemels, MAC, Bloemenkamp, KWM, Bosmans, JE, Kok, M, van Laar, JO, Sueters, M, Scheepers, H, van Drongelen, J, Franssen, MTM, Sikkema, JM, Duvekot, HJJ, Bekker, MN, van der Post, JAM, Naaktgeboren, C, Mol, BWJ & Oudijk, MA 2017, 'Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial', BMC Pregnancy and Childbirth, vol. 17, 223. https://doi.org/10.1186/s12884-017-1338-0

TY - JOUR

T1 - Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study

T2 - a multicenter randomized placebo controlled trial

AU - Visser, Laura

AU - de Boer, Marjon A.

AU - de Groot, Christianne J. M.

AU - Nijman, Tobias A. J.

AU - Hemels, Marieke A. C.

AU - Bloemenkamp, Kitty W. M.

AU - Bosmans, Judith E.

AU - Kok, Marjolein

AU - van Laar, Judith O.

AU - Sueters, Marieke

AU - Scheepers, Hubertina

AU - van Drongelen, Joris

AU - Franssen, Maureen T. M.

AU - Sikkema, J. Marko

AU - Duvekot, Hans J. J.

AU - Bekker, Mireille N.

AU - van der Post, Joris A. M.

AU - Naaktgeboren, Christiana

AU - Mol, Ben W. J.

AU - Oudijk, Martijn A.

PY - 2017/7/14

Y1 - 2017/7/14

N2 - Background: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-) effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial.Methods/design: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) <37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost- effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo.Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth.

AB - Background: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-) effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial.Methods/design: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) <37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost- effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo.Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth.

KW - Pregnancy

KW - 'Spontaneous recurrent preterm birth'

KW - SPTB

KW - Preterm birth

KW - Preterm labour

KW - PTB

KW - Prevention

KW - Reduction

KW - Aspirin

KW - Acetylsalicylic acid

KW - ASA

KW - LOW-BIRTH-WEIGHT

KW - TASK-FORCE

KW - PHYSIOLOGICAL TRANSFORMATION

KW - PREGNANCY COMPLICATIONS

KW - SPIRAL ARTERIES

KW - META-ANALYSIS

KW - DELIVERY

KW - MEMBRANES

KW - PREECLAMPSIA

KW - METAANALYSIS

U2 - 10.1186/s12884-017-1338-0

DO - 10.1186/s12884-017-1338-0

M3 - Article

SN - 1471-2393

VL - 17

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

M1 - 223

ER -

Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial

Abstract

Keywords

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