STUDY PROTOCOL Open Access
Efficacy of a midwife-coordinated,
individualized, and specialized maternity
care intervention (ChroPreg) in addition to
standard care in pregnant women with
chronic disease: protocol for a parallel
randomized controlled trial
Mie Gaarskjaer de Wolff
1,2,3*
, Marianne Johansen
1,4
, Anne S. Ersbøll
1,5
, Susanne Rosthøj
6
, Anne Brunsgaard
2
,
Julie Midtgaard
7,8
, Ann Tabor
9,10
and Hanne Kristine Hegaard
1,2,11
Abstract
Background and objectives: The number of women of childbearing age with chronic diseases is rising. Evidence has
shown that obstetric complications and poor psychological well-being are more prevalent among this group, in
addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate
how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown
that care coordination, continuity of care, woman-centered care, and specialized maternity care interventions delivered
to women with high-risk pregnancies can improve patient-reported outcomes and pregnancy outcomes and be cost-
effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among
pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a
midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard
care for pregnant women with chronic diseases.
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© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
* Correspondence: mie.gaarskjaer.de.wolff.01@regionh.dk
1
Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet,
Blegdamsvej 9, 2100 Copenhagen, Denmark
2
Research Unit for Women’s and Children’s Health, The Juliane Marie Centre,
Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100
Copenhagen, Denmark
Full list of author information is available at the end of the article
de Wolff et al. Trials (2019) 20:291
https://doi.org/10.1186/s13063-019-3405-5