Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial

E.O.G. van Vliet; L. Seinen; C. Roos; E. Schuit; H. C J Scheepers; K. W M Bloemenkamp; J. J. Duvekot; J. van Eyck; J. H. Kok; F. K. Lotgering; A. van Baar; A. G. van Wassenaer-Leemhuis; M. T. Franssen; M. M. Porath; J. A M van der Post; A. Franx; B. W J Mol; M. A. Oudijk

doi:10.1111/1471-0528.13586

Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial

E.O.G. van Vliet, L. Seinen, C. Roos, E. Schuit, H. C J Scheepers, K. W M Bloemenkamp, J. J. Duvekot, J. van Eyck, J. H. Kok, F. K. Lotgering, A. van Baar, A. G. van Wassenaer-Leemhuis, M. T. Franssen, M. M. Porath, J. A M van der Post, A. Franx, B. W J Mol, M. A. Oudijk^*

^*Corresponding author for this work

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

2 Citations (Scopus)

Abstract

Objective

To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant.

Design, Setting and Population

Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo.

Methods

Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire.

Main outcome measures

Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry.

Results

Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29–9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04).

Conclusions

This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time.

Tweetable abstract

No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.

Original language	English
Pages (from-to)	1107-1114
Number of pages	8
Journal	BJOG - An International Journal of Obstetrics and Gynaecology
Volume	123
Issue number	7
DOIs	https://doi.org/10.1111/1471-0528.13586
Publication status	Published - 2016

Keywords

Maintenance tocolysis
nifedipine
outcome
preterm birth

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10.1111/1471-0528.13586

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van Vliet, E. O. G., Seinen, L., Roos, C., Schuit, E., Scheepers, H. C. J., Bloemenkamp, K. W. M., Duvekot, J. J., van Eyck, J., Kok, J. H., Lotgering, F. K., van Baar, A., van Wassenaer-Leemhuis, A. G., Franssen, M. T., Porath, M. M., van der Post, J. A. M., Franx, A., Mol, B. W. J., & Oudijk, M. A. (2016). Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial. BJOG - An International Journal of Obstetrics and Gynaecology, 123(7), 1107-1114. https://doi.org/10.1111/1471-0528.13586

@article{cb2cf950c9754d3884a2884d949ac0c0,

title = "Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial",

abstract = " Objective To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant. Design, Setting and Population Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo. Methods Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire. Main outcome measures Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry. Results Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29–9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04). Conclusions This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time. Tweetable abstract No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome. ",

keywords = "Maintenance tocolysis, nifedipine, outcome, preterm birth",

author = "{van Vliet}, E.O.G. and L. Seinen and C. Roos and E. Schuit and Scheepers, {H. C J} and Bloemenkamp, {K. W M} and Duvekot, {J. J.} and {van Eyck}, J. and Kok, {J. H.} and Lotgering, {F. K.} and {van Baar}, A. and {van Wassenaer-Leemhuis}, {A. G.} and Franssen, {M. T.} and Porath, {M. M.} and {van der Post}, {J. A M} and A. Franx and Mol, {B. W J} and Oudijk, {M. A.}",

year = "2016",

doi = "10.1111/1471-0528.13586",

language = "English",

volume = "123",

pages = "1107--1114",

journal = "BJOG - An International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

publisher = "Wiley-Blackwell",

number = "7",

}

van Vliet, EOG, Seinen, L, Roos, C, Schuit, E, Scheepers, HCJ, Bloemenkamp, KWM, Duvekot, JJ, van Eyck, J, Kok, JH, Lotgering, FK, van Baar, A, van Wassenaer-Leemhuis, AG, Franssen, MT, Porath, MM, van der Post, JAM, Franx, A, Mol, BWJ & Oudijk, MA 2016, 'Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial', BJOG - An International Journal of Obstetrics and Gynaecology, vol. 123, no. 7, pp. 1107-1114. https://doi.org/10.1111/1471-0528.13586

TY - JOUR

T1 - Maintenance tocolysis with nifedipine in threatened preterm labour

T2 - 2-year follow up of the offspring in the APOSTEL II trial

AU - van Vliet, E.O.G.

AU - Seinen, L.

AU - Roos, C.

AU - Schuit, E.

AU - Scheepers, H. C J

AU - Bloemenkamp, K. W M

AU - Duvekot, J. J.

AU - van Eyck, J.

AU - Kok, J. H.

AU - Lotgering, F. K.

AU - van Baar, A.

AU - van Wassenaer-Leemhuis, A. G.

AU - Franssen, M. T.

AU - Porath, M. M.

AU - van der Post, J. A M

AU - Franx, A.

AU - Mol, B. W J

AU - Oudijk, M. A.

PY - 2016

Y1 - 2016

N2 - Objective To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant. Design, Setting and Population Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo. Methods Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire. Main outcome measures Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry. Results Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29–9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04). Conclusions This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time. Tweetable abstract No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.

AB - Objective To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant. Design, Setting and Population Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo. Methods Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire. Main outcome measures Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry. Results Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29–9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04). Conclusions This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time. Tweetable abstract No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.

KW - Maintenance tocolysis

KW - nifedipine

KW - outcome

KW - preterm birth

UR - http://www.scopus.com/inward/record.url?scp=84978431981&partnerID=8YFLogxK

U2 - 10.1111/1471-0528.13586

DO - 10.1111/1471-0528.13586

M3 - Article

C2 - 26330379

AN - SCOPUS:84978431981

SN - 1470-0328

VL - 123

SP - 1107

EP - 1114

JO - BJOG - An International Journal of Obstetrics and Gynaecology

JF - BJOG - An International Journal of Obstetrics and Gynaecology

IS - 7

ER -

Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial

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Keywords

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