Condition category
Mental and Behavioural Disorders
Date applied
27/07/2007
Date assigned
03/10/2007
Last edited
03/10/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Suzanne Tough

ORCID ID

Contact details

Alberta Children's Hospital (ACH)
c/o Decision Support Research Team
Room C4-301
2888 Shaganappi Trail NW
Calgary
T3B 6A8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

It was hypothesised that group prenatal care would improve maternal mental health (depression and anxiety), psychosocial health (social support, stress, parenting morale, parenting self-efficacy) and infant birth outcomes (low birth weight, small for gestational age and preterm birth rates) compared to individual prenatal care among a community sample of women in Calgary, Alberta.

Ethics approval

Ethics approval received from the Conjoint Health Research Ethics Board, University of Calgary and Calgary Health Region on the 7th June 2007 (ref: E-20821).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Maternal mental health

Intervention

Pregnant women are randomised to:
1. Standard individual prenatal care
2. Group prenatal care

Control: Standard Prenatal Care
Women randomly assigned to individual prenatal care will receive a standard schedule of one-on-one prenatal visits with a physician. The timing and frequency of visits will be decided by each womens' physician, although it is anticipated that they will follow the clinical practice guidelines, Healthy Beginnings: Guidelines for Care during Pregnancy and Childbirth provided by the Society for Obstetrics and Gynaecologists of Canada (SOGC). Women with high medical risk pregnancies will be referred for obstetrical care.

Intervention: Group Prenatal Care
Women randomly assigned to group prenatal care will receive an initial individual prenatal visit with a physician to confirm their pregnancy and subsequently will be grouped with 8 - 12 other women who are at a similar stage in pregnancy. Each group will meet with a health care provider for nine group sessions including one-on-one time with the provider for a prenatal check-up, time to conduct self measurements of their weight and blood pressure and a group discussion covering a topic appropriate to their stage of pregnancy. The group discussion will be co-facilitated by the physician and a perinatal educator who will encourage group members to participate in discussing topics of interest related to pregnancy, childbirth, parenting, and personal growth. These group sessions will take place at approximately 16, 20, 24, 28, 32, 34, 36, 38 weeks gestation and 2 weeks postpartum. Women will also receive individual prenatal visits at 37 and 39 weeks gestation. Women with high medical risk pregnancies will be referred for obstetrical care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Maternal mental health: depression and anxiety - measured at study intake (prior to 20 weeks gestation), third trimester (32 - 36 weeks gestation) and 4 months postpartum
2. Maternal psycho-social health:
2.1. Social support and stress - measured at study intake (prior to 20 weeks gestation) and 4 months postpartum
2.2. Parenting morale and parenting self efficacy - measured at 4 months postpartum

Secondary outcome measures

1. Rates of infant birth outcomes (low birth weight, small for gestational age, preterm birth) - measured at birth
2. Rates of breast feeding, uptake of parenting classes/supports, attendance at well child visits, immunisation rates - measured at 4 months postpartum

Overall trial start date

01/11/2007

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant woman living in Northeast Calgary
2. Less than 20 weeks gestation at study intake
3. Able to communicate in English, Punjabi, Mandarin, Hindi, Arabic, Urdu or Spanish

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

1200

Participant exclusion criteria

1. Pregnant woman living outside Northeast Calgary
2. Greater than 20 weeks gestation at study intake
3. Unable to communicate in English, Punjabi, Mandarin, Hindi, Arabic, Urdu or Spanish

Recruitment start date

01/11/2007

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Alberta Children's Hospital (ACH)
Calgary
T3B 6A8
Canada

Sponsor information

Organisation

Calgary Health Region (Canada) - Three Cheers for the Early Years

Sponsor details

5th Floor
1509 Centre Street South
Calgary
T2G 2E6
Canada

Sponsor type

Research organisation

Website

http://www.calgaryhealthregion.ca/3cheers/home.htm

Funders

Funder type

Research organisation

Funder name

Calgary Health Region (Canada) - Three Cheers for the Early Years

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alberta Heritage Foundation for Medical Research (Canada)

Alternative name(s)

AHFMR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes