Group Based Care Versus Individual Care

Study Overview
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Brief Summary
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The Study compares group based care versus individual given care-effects on patient satisfaction and health. Midwives will be randomized to either traditional antenatal care (Individual care) or group based antenatal care(intervention).

Detailed Description
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In the RCT the midwife is randomized.There are a multicenter study. Before the study started the midwives received education about the study. Then they randomized with simple randomization per site(clinics). The midwives also have follow up meeting with the research team during the recruting period. The parents are informed about the study at the booking appointment, after that they can choose if they want to participate in the study and are allocated to either intervention or control, based on the woman's date of birth. The main aim is to investigate parents' satisfaction of antenatal group based care. The RCT is based on three questionnaires which both women and their partners receive, the first at baseline before they receive different models of care, and the second questionnaire distributed four to six months after birth and the last one year after birth. Descriptive and inferential statistics will be used in the analysis.A power calculation is made and the study schould have a total number of 350 partners.

Official Title
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Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Other: group based care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to Speak Swedish Exclusion Criteria: Non speaking Swedish
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group antenatal care<br>The first arm is midwife which allocated to group based antenatal care. They have education in this model of care and follow up meeting to secure the intervention | Other: group based care<br>* Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care.<br>* Other names: intervention including midwifes in the care.;|
| No Intervention: Individual antenaal care<br>the second arm include midwife which allocated to traditional care as control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group based antenatal care versus Individual care- parent´s satisfaction with care | Satisfaction with care and involvement of partner, three questionnaire to parents in control group and intervention group, which measure the satisfaction with care | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| socialization with other parents | The study include this secondary outcome, measure with two qustionnarie four to six mounts after birth and the second qustionnarie one year after birth. The questionnare to borth group(conrtil group and intervention griup) | 4 years | 
| Self reported health effect on mother and child | Measure the health with instrument as EPDS scale and question regarding health, parental stress and breastfeeding.Four to six months and one year after birth. The questionnaire is sending out to both woman and partner. | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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group based care, antenatal care, parents satisfaction, Antenatal care´s organization and patient satisfaction