A randomised controlled trial comparing group to individual prenatal care

ISRCTN	ISRCTN46330948
DOI	https://doi.org/10.1186/ISRCTN46330948
Protocol serial number	N/A
Sponsor	Calgary Health Region (Canada) - Three Cheers for the Early Years
Funders	Calgary Health Region (Canada) - Three Cheers for the Early Years, Alberta Heritage Foundation for Medical Research (Canada)

Submission date: 27/07/2007
Registration date: 03/10/2007
Last edited: 03/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Suzanne Tough
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	1200
Key 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
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

Canada

Study participating centre

Alberta Children's Hospital (ACH)

Calgary
T3B 6A8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan