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.

Methods/design

This two-arm parallel group RCT will be conducted from October 2018 through June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: (1) coordinated and individualized care, (2) additional ante- and postpartum consultations, and (3) specialized midwives. The primary outcome is length of hospital stay during pregnancy and in the postpartum period, and secondary outcomes are psychological well-being (five-item World Health Organization Well-Being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (12-Item Short Form Health Survey), patient satisfaction (Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data are collected via patient-administered questionnaires and medical records.

Discussion

This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra-, and postpartum care for women with chronic disease is founded.

Trial registration

ClinicalTrials.gov, NCT03511508. Registered April 27, 2018.

Details

Title
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
Author
de Wolff, Mie Gaarskjaer 1   VIAFID ORCID Logo  ; Johansen, Marianne 2 ; Ersbøll, Anne S. 3 ; Rosthøj, Susanne 4 ; Brunsgaard, Anne 5 ; Midtgaard, Julie 6 ; Tabor, Ann 7 ; Hegaard, Hanne Kristine 8 

1  Copenhagen University Hospital, Department of Obstetrics, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); Copenhagen University Hospital, Research Unit for Women’s and Children’s Health, The Juliane Marie Centre, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); Copenhagen University, Faculty of Health and Medical Science, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X) 
2  Copenhagen University Hospital, Department of Obstetrics, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); Copenhagen University Hospital Rigshospitalet, Center for Pregnancy and Heart Disease, Copenhagen, Denmark (GRID:grid.475435.4) 
3  Copenhagen University Hospital, Department of Obstetrics, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); North Zealand Hospital, Department of Gynecology and Obstetrics, Hillerød, Denmark (GRID:grid.4973.9) 
4  University of Copenhagen, Section of Biostatistics, Department of Public Health, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X) 
5  Copenhagen University Hospital, Research Unit for Women’s and Children’s Health, The Juliane Marie Centre, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373) 
6  The University Hospitals Centre for Health Research (UCSF), Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark (GRID:grid.475435.4); University of Copenhagen, Department of Public Health, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X) 
7  Copenhagen University Hospital, Center of Fetal Medicine and Pregnancy, Department of Obstetrics, Copenhagen Ø, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); University of Copenhagen, Faculty of Health Sciences, Copenhagen N, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X) 
8  Copenhagen University Hospital, Department of Obstetrics, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); Copenhagen University Hospital, Research Unit for Women’s and Children’s Health, The Juliane Marie Centre, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373); University of Copenhagen, The Institute of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X) 
Pages
291
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3405-5
ProQuest document ID
2795352316
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.