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Completed

NCT Number: NCT01224275

Group Based Care Versus Individual Care

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).

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institut-Woman and childrens health

Stockholm, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to Speak Swedish

Exclusion criteria

  • Non speaking Swedish

Treatment and study plan

group based care

Other

Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care.

Other names: intervention including midwifes in the care.

Primary outcomes

  1. Group based antenatal care versus Individual care- parent´s satisfaction with care

    Time frame: 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 outcomes

  1. socialization with other parents

    Time frame: 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)

  2. Self reported health effect on mother and child

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: GBAC

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Oct 20, 2010
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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