PregnancyNCT02526459
The Effect of Birth Plans on Obstetrical Outcomes
A study testing Birth plan in people with Pregnancy, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
Trial summary
The study design is a prospective, single institution, randomized control trial in which the introduction of a birth plan is the intervention and a comparison of the rate of Caesarean sections between participants in the control group (no birth plan) and the experimental group (birth plan) is the primary outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Birth plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has singleton pregnancy
- Patient has baby with cephalic presentation
- Patient is at less than 34 weeks gestation
Who cannot join
- Patient has planned Caesarean section
- Patient has planned pre-existing birth plan
- Patient has intrauterine fetal demise
- Patient having a fetus with congenital anomalies
- Existence of intrauterine growth restriction
- Existence of oligohydramnios
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Birth Plans on Obstetrical Outcomes: a Randomized Control Trial
The study design is a prospective, single institution, randomized control trial in which the introduction of a birth plan is the intervention and a comparison of the rate of Caesarean sections between participants in the control group (no birth plan) and the experimental group (birth plan) is the primary outcome.
Read the detailed description
The study design is a prospective, single institution, randomized control trial in which the introduction of a birth plan is the intervention and a comparison of the rate of Caesarean sections between participants in the control group (no birth plan) and the experimental group (birth plan) is the primary outcome. In addition, a variety of maternal variables such as epidural use, induction of labour, and excessive blood loss will be collected to be compared between the two groups as it is anticipated that these could have a confounding effect on whether a Caesarean section will be used or not. Furthermore, neonatal outcomes such as birth weight, presence of meconium, and APGAR scores <7 at 5 minutes are also collected for this purpose. A complete list of all collected variable can be found in the data collection form. Patients will be enrolled by Dr. Rashmi Bhargava who sees approximately an average of one patient a day who would be eligible to participate in this project. The investigators aim to enroll a total of about 200 patients from this group over the next 12 to 18 months.
Potential research participants will be approached by the PI, who is a staff obstetrician, during office visits at approximately 34 weeks gestational age. The study will be explained and if the patient is interested in participation, she will receive the study's consent form to take home and look over. It will be stressed to her that she is under no obligation to participate and if she decides not to participate or discontinue participation at a later time, the standard of care she will receive will not be affected. At the following prenatal visit (approximately 36 weeks), patients will bring the completed consent form and concurrently be randomized to either the birth plan group or the control group. Only those randomized to the birth plan group will be provided with a template to assist them in the construction of an individualized birth plan. The staff obstetrician will review and finalize these birth plans and answer any questions the participant may have in the following prenatal visit (approximately 37 weeks). The finalized birth plan will be taken home by the participant, while a copy will be made and faxed from Dr. Bhargava's office to the Labour and Birth Unit at the Regina General Hospital and placed in the participant's file. This way, the birth plan will available for when the participant arrives at RGH for child birth in case she did not bring the original with her. All office visits are scheduled as per normal procedures (standard of care) and are not scheduled solely for the purpose of this research project.
Participants will be randomized in a 1:1 ratio using permuted blocks of 6. A computer generated (SPSS) algorithm will be used to create the randomization sequence table before recruitment starts. Participants will be informed of their allocation at the time of their consent by their obstetrician.
All data will be collected from the participant's chart, except for her rating of childbirth satisfaction, which will be collected through the Mackey Childbirth Satisfaction Rating Scale. This online questionnaire will be completed by patients postpartum using a secure website (FluidSurveys) as an assessment of their satisfaction in labour. To this end, participants are asked to provide their email address on the consent form if they like to complete this questionnaire. Participants will be contacted by email for collection of these surveys about two weeks after child birth. Participants will be required to list their name with their responses so the data can be linked to their other data. As soon as the questionnaire data is collected and the data is linked, the participant's name will be removed and replaced by her study ID.
- Conditions
- Pregnancy
- Being tested
- Birth plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth planBehavioural
Patient will receive a birth plan
| Study group | Role | What they receive |
|---|---|---|
| birth plan | Experimental | Use of birth plan Receives: Behavioral: Birth plan |
| no birth plan | No intervention | No use of birth plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean sections (yes/no variable)
Was a Caesarean section used to deliver the baby? (yes/no variable abstracted from medical chart)
Measured: 4 weeks
Secondary outcomes (3)
neonatal outcome: APGAR<7
Scale (abstracted from medical chart)
Measured: 4 weeks
neonatal outcome: low birth weight
Variable abstracted from medical chart
Measured: 4 weeks
Childbirth Satisfaction (questionnaire)
Mackey Childbirth Satisfaction Rating Scale - It rates different satisfaction aspects on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rashmi Bhargava, Saskatchewan Health Authority - Regina Area
- Investigators
- Rashmi Bhargava, MD, Principal investigator, RQHR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526459
- Sponsor's protocol ID
- REB-15-31
- Status last verified
- Sep 2019
- First submitted
- 31 Jul 2015
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Birth Plans on Obstetrical Outcomes: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02526459
- Acronym / sponsor ID
- REB-15-31
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study design is a prospective, single institution, randomized control trial in which the introduction of a birth plan is the intervention and a comparison of the rate of Caesarean sections between participants in the control group (no birth plan) and the experimental group (birth plan) is the primary outcome.
Detailed description
The study design is a prospective, single institution, randomized control trial in which the introduction of a birth plan is the intervention and a comparison of the rate of Caesarean sections between participants in the control group (no birth plan) and the experimental group (birth plan) is the primary outcome. In addition, a variety of maternal variables such as epidural use, induction of labour, and excessive blood loss will be collected to be compared between the two groups as it is anticipated that these could have a confounding effect on whether a Caesarean section will be used or not. Furthermore, neonatal outcomes such as birth weight, presence of meconium, and APGAR scores <7 at 5 minutes are also collected for this purpose. A complete list of all collected variable can be found in the data collection form. Patients will be enrolled by Dr. Rashmi Bhargava who sees approximately an average of one patient a day who would be eligible to participate in this project. The investigators aim to enroll a total of about 200 patients from this group over the next 12 to 18 months.
Potential research participants will be approached by the PI, who is a staff obstetrician, during office visits at approximately 34 weeks gestational age. The study will be explained and if the patient is interested in participation, she will receive the study's consent form to take home and look over. It will be stressed to her that she is under no obligation to participate and if she decides not to participate or discontinue participation at a later time, the standard of care she will receive will not be affected. At the following prenatal visit (approximately 36 weeks), patients will bring the completed consent form and concurrently be randomized to either the birth plan group or the control group. Only those randomized to the birth plan group will be provided with a template to assist them in the construction of an individualized birth plan. The staff obstetrician will review and finalize these birth plans and answer any questions the participant may have in the following prenatal visit (approximately 37 weeks). The finalized birth plan will be taken home by the participant, while a copy will be made and faxed from Dr. Bhargava's office to the Labour and Birth Unit at the Regina General Hospital and placed in the participant's file. This way, the birth plan will available for when the participant arrives at RGH for child birth in case she did not bring the original with her. All office visits are scheduled as per normal procedures (standard of care) and are not scheduled solely for the purpose of this research project.
Participants will be randomized in a 1:1 ratio using permuted blocks of 6. A computer generated (SPSS) algorithm will be used to create the randomization sequence table before recruitment starts. Participants will be informed of their allocation at the time of their consent by their obstetrician.
All data will be collected from the participant's chart, except for her rating of childbirth satisfaction, which will be collected through the Mackey Childbirth Satisfaction Rating Scale. This online questionnaire will be completed by patients postpartum using a secure website (FluidSurveys) as an assessment of their satisfaction in labour. To this end, participants are asked to provide their email address on the consent form if they like to complete this questionnaire. Participants will be contacted by email for collection of these surveys about two weeks after child birth. Participants will be required to list their name with their responses so the data can be linked to their other data. As soon as the questionnaire data is collected and the data is linked, the participant's name will be removed and replaced by her study ID.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| birth plan | Experimental | Behavioral: Birth planUse of birth plan |
| no birth plan | No intervention | –No use of birth plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has singleton pregnancy
- Patient has baby with cephalic presentation
- Patient is at less than 34 weeks gestation
Key exclusion criteria (6 listed)
- Patient has planned Caesarean section
- Patient has planned pre-existing birth plan
- Patient has intrauterine fetal demise
- Patient having a fetus with congenital anomalies
- Existence of intrauterine growth restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birth planPatient will receive a birth plan | Behavioural | birth plan |
Primary outcome
Caesarean sections (yes/no variable)
Time frame: 4 weeks
Was a Caesarean section used to deliver the baby? (yes/no variable abstracted from medical chart)
3 secondary outcomes
neonatal outcome: APGAR<7
Time frame: 4 weeks
neonatal outcome: low birth weight
Time frame: 4 weeks
Childbirth Satisfaction (questionnaire)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Bhargava, MD principal investigator
RQHR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birth plan in people with Pregnancy, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean sections (yes/no variable) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.