NCT03511508: ChroPreg

Pregnancy and Chronic Disease: The Effect of a Midwife-coordinated Maternity Care Intervention

Completed NA Last updated 10 March 2021

What this trial tests

NA trial testing ChroPreg + standard care in Chronic Diseases in Pregnancy in 262 participants. Completed in 1 October 2020.

Timeline

1 October 2018

Primary endpoint
15 August 2020

1 October 2020

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	262
Start date	1 October 2018
Primary completion	15 August 2020
Estimated completion	1 October 2020
Sites	1 location across Denmark

Drugs / interventions tested

• ChroPreg + standard care

Conditions studied

• Chronic Diseases in Pregnancy — all drugs for Chronic Diseases in Pregnancy →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 18 to 50, female only, with Chronic Diseases in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The number of pregnant women affected by chronic diseases such as epilepsy, hypertension and thyroid disease is rising, and in the Danish population 15 % of all pregnant women had a chronic disease in 2016. Chronic disease increase the risk of complications during pregnancy such as preterm birth and caesarian section, while children born of mothers with chronic disease have an increased risk of low birthweight, prematurity and birth effects. Moreover, pregnant women with chronic disease have an increased risk of post-natal depression and report higher rates of anxiety during pregnancy and have described dissatisfaction with the communication with care providers about issues such as breastfeeding, lack of coherence during the course of pregnancy and after delivery.

The purpose of this study is to examine the effect of an increased, interdisciplinary, coordinated and specialized maternity care multimodal intervention for pregnant women with chronic disease on the length of hospitalization (during pregnancy and after delivery). Secondarily, the purpose is to examine the effect of the intervention on psychological well-being and patient satisfaction.

The investigators hypothesis is that the delivery of an increased interdisciplinary, coordinated and specialized intervention targeted pregnant women with pre-existing chronic disease will be beneficial for this group of pregnant women's' length of hospitalization during pregnancy and after delivery due to improved maternity care and improved self-care. Also, the investigators hypothesize that the effect of the intervention will be improved psychological well-being and satisfaction with care during pregnancy and after delivery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a Midwife-Coordinated Maternity Care Intervention (ChroPreg) vs. Standard Care in Pregnant Women with Chronic Medical Conditions: Results from a Randomized Controlled Trial.
   de Wolff MG, Midtgaard J, Johansen M, Rom AL, et al · · 2021 · cited 9× · PMID 34360168 · DOI 10.3390/ijerph18157875
2. 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.
   de Wolff MG, Johansen M, Ersbøll AS, Rosthøj S, et al · · 2019 · cited 9× · PMID 31138296 · DOI 10.1186/s13063-019-3405-5