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

NCT03511508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2021-03-10

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Diseases in Pregnancy

Interventions

BEHAVIORAL

ChroPreg + standard care

* Ongoing update of individual maternity care plan. * Extra consultation with the specialized midwife at 20-24 weeks of pregnancy about psychological well-being during pregnancy. * Extra consultation with the specialized midwife at 30-33 weeks of pregnancy about individual birth preparation, breastfeeding and post-partum care. * Possibility for psychologist consultation. * Post-partum: Telephone follow-up by the specialized midwife 1 and 2 weeks after discharge. * Postnatal follow-up: 4-6 weeks after delivery: conversation with specialized midwife about the pregnancy and birth.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Hanne K Hegaard, PhD · Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-08-15
Completion
2020-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511508 on ClinicalTrials.gov