A randomised controlled trial comparing group to individual prenatal care
| ISRCTN | ISRCTN46330948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46330948 |
| Secondary identifying numbers | N/A |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 01/11/2007 |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 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
T3B 6A8
Canada
Sponsor information
Calgary Health Region (Canada) - Three Cheers for the Early Years
Research organisation
Research organisation
5th Floor
1509 Centre Street South
Calgary
T2G 2E6
Canada
| Website | http://www.calgaryhealthregion.ca/3cheers/home.htm |
|---|---|
"ROR" |
https://ror.org/02nt5es71 |
Funders
Funder type
Research organisation
Calgary Health Region (Canada) - Three Cheers for the Early Years
No information available
Alberta Heritage Foundation for Medical Research (Canada)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- AHFMR
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
