Group Based Care Versus Individual Care

Not Applicable

Completed

• Conditions: Patient Satisfaction
• Interventions: Other: group based care

• Registration Number: NCT01224275
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2014-06
• Study Completion: 2015-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

• Must be able to Speak Swedish

Exclusion Criteria

• Non speaking Swedish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group antenatal care	group based care	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
socialization with other parents	4 years	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)
Self reported health effect on mother and child	6 years	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.

Trial Locations

Locations (1)

Karolinska Institut-Woman and childrens health; 🇸🇪 Stockholm, Sweden