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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511508
Recruitment Status : Completed
First Posted : April 27, 2018
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hanne Kristine Hegaard, Rigshospitalet, Denmark

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Diseases in Pregnancy Behavioral: ChroPreg + standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention Group and Control group
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ChroPreg
The participants in the intervention Group receive the midwife-coordinated, individualized and specialized intervention plus standard care
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.

No Intervention: Standard care alone

Participants in the control group receive the standard care for pregnant women with chronic disease.

The standard care is given to the participants in the control group. The standard care for pregnant women with chronic disease include five routine visits at a non-specialized midwife and an individually scheduled number of visits with an obstetrician, depending on the type and severity of the chronic Medical disease and possible pregnancy complications.

The women in the control Group have the same amount of ultrasound examinations as do the women in the intervention Group.

Women in the control Group can attend auditorium antenatal classes at the hospital.




Primary Outcome Measures :
  1. Hospitalization, length of stay (LOS) [ Time Frame: 2 weeks post-partum ]
    The duration of hospitalization will be measured in days (mean and SD)


Secondary Outcome Measures :
  1. World Health Organization Five Well-being Index (WHO-5) [ Time Frame: 33th-37th week of gestation and 2 months after delivery ]
    Psychological well-being will be measured by the World Health Organization Five Well-being Index (WHO-5) (mean and SD) or (median and range).

  2. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 33th-37th week of gestation and 2 months after delivery ]
    Symptoms of depression measured by the Edinburgh Postnatal Depression Scale (EPDS) will be defined as cutoff score ≥ 13 and a cutoff score ≥ 10. The scale measures the intensity of common depressive symptoms on a 4-point Likert scale (0-3), where 0 indikates absence of depressive symptoms and 3 indicates the highgest amount of depressive symptoms. The lowest score of the scale is 0 and the highest total score is 30.

  3. Cambridge Worry Scale (CWS) [ Time Frame: 33th-37th week of gestation ]
    The degree of worry during pregnancy measured by the Cambridge Worry Scale (CWS) will be defined as an overall score (mean/SD) or (median/range). The scal consists of a 16 items on a 6-point Likert scale (0-5). The highest total score is 80 indicating the highest level of worry and the lowest score is 0 indicating the lowest level of worry during pregnancy.

  4. Pregnancy & Childbirth Questionnaire (PCQ) [ Time Frame: 2 months after delivery ]
    Patient satisfaction will be measured by the Pregnancy & Childbirth Questionnaire (PCQ) (mean and SD) or (median and range). The scale consists of 25 items on a 5-point Likert scale (0-4). The highest total score is 100 indicating the highest level of satisfaction and the lowest score is 0 indicating the lowest level of satisfaction. The scale can be divided in two subscales. the first subscale measures satisfaction with pregnancy care and education and information and consists of the first 18 items on the total scale. The second subscale measures satisfaction with childbirth and consists of the last 7 items of the total scale.

  5. number of outpatient visits [ Time Frame: 2 weeks post-partum ]
    Outpatient visits will be measured by the number of outpatient visits (mean and SD) or (median and range).

  6. Mode of delivery [ Time Frame: 2 weeks post-partum ]
    Mode of delivery will be measured with respectively spontaneous vaginal delivery, vacuum extraction or caesarian section (n/%)

  7. Onset of labor [ Time Frame: 2 weeks post-partum ]
    Onset of labor will be measures will be measured with respectively spontaneous onset of labor or induced labor (n/%).

  8. Preterm delivery (delivery before 37 full gestational weeks) [ Time Frame: 2 weeks post-partum ]
    Preterm delivery will be measured by yes or no (n/%).

  9. Use of epidural analgesia [ Time Frame: 2 weeks post-partum ]
    Use of epidural analgesia will be measured by yes or no (n/%).

  10. Pregnancy complicated by pre-eclampsia [ Time Frame: 2 weeks post-partum ]
    Pre-eclampsia will be measured by yes or no (n/%l).

  11. Pregnancy complicated by pregnancy-induced hypertension [ Time Frame: 2 weeks post-partum ]
    Pregnancy-induced hypertension will be measured by yes or no (n/%).

  12. Pregnancy complicated with gestational diabetes [ Time Frame: 2 weeks post-partum ]
    Gestational diabetes will be measured by yes or no (n/%).

  13. Birth weight in kilograms [ Time Frame: 2 weeks post-partum ]
    Birth weight will be measured in kilograms (mean and SD).

  14. Newborn's well-being at time of delivery (Apgar-score) [ Time Frame: 2 weeks post-partum ]

    Newborn's well-being at time of delivery will be measured by Apgar-score (yes no to an Apgar-score ≤ 7 at 5 minutes post-partum) (n/%).

    Newborn's well-being at time of delivery will be measured by Apgar-score (yes no to an Apgar-score ≤ 7 at 5 minutes post-partum) (OR and 95 % confidence interval).


  15. Newborn's well-being at time of delivery (pH-value in cord blood) [ Time Frame: 2 weeks post-partum ]
    Newborn's well-being at time of delivery will be measured by the pH-value in the cord blood at time of delivery (mean/SD) or (median and range).

  16. Breastfeeding (2 months after delivery) [ Time Frame: 2 months after delivery ]

    Breastfeeding will be measured by yes/no at 2 months after delivery (n/%).

    Breastfeeding will be measured by yes/no at 2 months after delivery (OR and 95% confidence interval).

    Breastfeeding will be measured by yes/no at 2 months after delivery (OR and 95% confidence interval).


  17. Intention to breastfeed [ Time Frame: 33-37 weeks of gestation ]
    Intention to breastfeed will be measured by yes/no at 33-37 weeks of gestation (N/%).

  18. Intended duration of breastfeeding. [ Time Frame: 2 months after delivery ]
    Intended duration of breastfeeding will be measured in months (mean/SD) or (median and range)

  19. Satisfaction with breastfeeding [ Time Frame: 2 months after delivery ]
    Satisfaction with breastfeeding. Satisfaction with breastfeeding will be measured on a scale from really good to bad (5 categories)(n/%).

  20. Overall satisfaction with maternity care [ Time Frame: 2 months after delivery ]
    Overall satisfaction with maternity care will be measured by percentage of participants in each of the five categories of satisfaction (really good, good, moderate, not so good, poor) (n/%).

  21. Self-evaluated ability to cope with breastfeeding [ Time Frame: 2 months after delivery ]
    Self-evaluated ability to cope with breastfeeding will be measured by percentage of participants in each of the five categories of satisfaction (really good, good, moderate, not so good, poor) (n/%).

  22. Self-evaluated ability to cope with chronic disease [ Time Frame: 2 months after delivery ]
    Self-evaluated ability to cope with chronic disease will be measured by percentage of participants in each of the five categories of satisfaction (really good, good, moderate, not so good, poor) (n/%).

  23. Self-evaluated ability to cope with the mother role [ Time Frame: 2 months after delivery ]
    Self-evaluated ability to cope with the mother role will be measured by percentage of participants in each of the five categories of satisfaction (really good, good, moderate, not so good, poor) (n/%).


Other Outcome Measures:
  1. Health related quality af lifeSF-12 [ Time Frame: 2 months after delivery ]
    The SF-12 questionnaire consists of 12 items that measure physical and mental health, divided into eight subscales: physical and social functioning, role limitation due to physical and mental health, bodily pain, general health perceptions (self-rated health), vitality, and mental health. The scores from the subscales can be calculated in two overall scores: Physical Component Summary (PCS) and Mental Component Summary (MCS) with higher scores indicating better health-related quality of life



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511508


Locations
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Denmark
Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Hanne K Hegaard, PhD Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Study Protocol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanne Kristine Hegaard, Midwife, ph.d. Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03511508    
Other Study ID Numbers: ChroPreg
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanne Kristine Hegaard, Rigshospitalet, Denmark:
pregnancy
maternity Care
complex intervention
interdisiplinary team
chronic disease
interdisciplinary
midwifery
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes