AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

Canada1 site
  • Dr Rashmi Bhargava

    Regina, Saskatchewan, S4P 0L9

Other trials in Canada

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 groups in NCT02526459
Study groupRoleWhat they receive
birth planExperimentalUse of birth plan
Receives: Behavioral: Birth plan
no birth planNo interventionNo use of birth plan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. neonatal outcome: APGAR<7

    Scale (abstracted from medical chart)

    Measured: 4 weeks

  2. neonatal outcome: low birth weight

    Variable abstracted from medical chart

    Measured: 4 weeks

  3. 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.

  1. First posted18 Aug 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in