Efficacy of a Midwife-coordinated, Individualized, and Specialized Maternity Care Intervention (ChroPreg) in Addition to Standard Care in Pregnant Women With Chronic Disease: a Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Hospitalization, length of stay (LOS)
研究概览
简要总结
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.
详细描述
Pregnant women with chronic disease such as epilepsy, sclerosis, hypertension, and thyroid disorders have a significant increased risk of pregnancy complications such as spontaneous abortion, preterm delivery, and caesarian section. Children born by mothers affected by chronic disease have a higher risk of low birthweight, prematurity and birth defects. Moreover women affected by chronic disease have a higher incidence of post-natal depression than women with no history of chronic disease.
Previous studies have found that pregnant some women with chronic disease experienced a lack of continuity in the maternity care: they felt that their different care providers were giving contradictory information on issues such as mode of delivery, breastfeeding and medications. This lack of continuity led to dissatisfaction with care and insecurity with decision-making.
Previous studies that evaluate maternity care interventions, have shown that the elements of the interventions that have a positive effect on pregnancy outcomes such as lowering pregnancy and birth complications, health costs and patient satisfaction are: increased care-coordination, continuity of care providers, specially trained care providers (e.g. nurses and midwives), specialized teams, focus on transitions from e.g. one care setting to another and individualized women-centered care.
However, none of these studies have been targeted pregnant women with chronic disease and how to optimize their course of maternity care. Moreover, systematic reviews point out that studies that examine the effect of the interventions on patient satisfaction, health costs and psychological well-being.
On this background, the purpose of this study is to examine the effect of a midwife-coordinated individualized and specialized maternity care 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women 18 years and above of age.
- •Pregnant women with one or more chronic diseases before pregnancy (e.g. epilepsy, hypertension, lung disease, thyroid disease, multiple sclerosis).
- •high-risk pregnancy with planned antenatal care with obstetrician
- •Pregnancy with a single fetus.
- •Ability to give written informed consent.
排除标准
- •Pregnant women below 18 years of age.
- •Multiple pregnancies.
- •Lack of ability to speak and understand Danish language.
- •Substance abuse problems
- •Women with diabetes mellitus before pregnancy and women with Heart disease ( these women already receive a special programme at the Deprtment of Obstetrics, Rigshospitalet)
- •Chronic psychiatric disease (as only chronic disease)
结局指标
主要结局
Hospitalization, length of stay (LOS)
时间窗: 2 weeks post-partum
The duration of hospitalization will be measured in days (mean and SD)
次要结局
- Edinburgh Postnatal Depression Scale (EPDS)(33th-37th week of gestation and 2 months after delivery)
- number of outpatient visits(2 weeks post-partum)
- Preterm delivery (delivery before 37 full gestational weeks)(2 weeks post-partum)
- Self-evaluated ability to cope with the mother role(2 months after delivery)
- World Health Organization Five Well-being Index (WHO-5)(33th-37th week of gestation and 2 months after delivery)
- Pregnancy & Childbirth Questionnaire (PCQ)(2 months after delivery)
- Birth weight in kilograms(2 weeks post-partum)
- Newborn's well-being at time of delivery (Apgar-score)(2 weeks post-partum)
- Mode of delivery(2 weeks post-partum)
- Onset of labor(2 weeks post-partum)
- Use of epidural analgesia(2 weeks post-partum)
- Pregnancy complicated by pre-eclampsia(2 weeks post-partum)
- Intention to breastfeed(33-37 weeks of gestation)
- Self-evaluated ability to cope with breastfeeding(2 months after delivery)
- Self-evaluated ability to cope with chronic disease(2 months after delivery)
- Breastfeeding (2 months after delivery)(2 months after delivery)
- Pregnancy complicated by pregnancy-induced hypertension(2 weeks post-partum)
- Pregnancy complicated with gestational diabetes(2 weeks post-partum)
- Satisfaction with breastfeeding(2 months after delivery)
- Intended duration of breastfeeding.(2 months after delivery)
- Cambridge Worry Scale (CWS)(33th-37th week of gestation)
- Newborn's well-being at time of delivery (pH-value in cord blood)(2 weeks post-partum)
- Overall satisfaction with maternity care(2 months after delivery)
研究者
Hanne Kristine Hegaard
Midwife, ph.d. Associate Professor
Rigshospitalet, Denmark