CesareanNCT01216098
Impact of Doula Support on Childbirth Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)
A study testing Doula support in people with Cesarean, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the impact of doula support on childbirth outcomes of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC). Doulas are paraprofessionals who provide women with continuous physical and emotional support throughout the course of labour. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean
- What is being tested?
- Doula support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Feb 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who have had at least one prior cesarean birth, are eligible for VBAC, and plan to attempt a VBAC after counseling at the Best Birth Clinic.
- Singleton gestation.
- Cephalic presentation.
- Term gestation (37-42 weeks at time of delivery).
Who cannot join
- Women who have a pre-existing medical condition that would be an indication for an elective cesarean birth.
- Women who plan to privately hire a doula regardless of placement in either arm of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Doula Support on Intrapartum Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)
The purpose of this study is to evaluate the impact of doula support on childbirth outcomes of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC). Doulas are paraprofessionals who provide women with continuous physical and emotional support throughout the course of labour. They also conduct home visits in the prenatal and postpartum periods in order to provide women with information on childbirth-related topics and breastfeeding support. They do not perform clinical tasks. Their value lies in the psycho-social care that they provide. It is hypothesized that women who receive doula support alongside standard care will have a lower rate of epidural analgesia use and greater cervical dilation at time of epidural administration, as compared to those who receive standard care alone.
Read the detailed description
A two-armed randomized controlled trial will be conducted at BC Women's Hospital. The experimental group will receive both standard clinical care and doula support. The control group will receive standard clinical care without doula support. The main outcomes being looked at are use of epidural analgesia and cervical dilation at time of epidural administration. These outcomes have been chosen because of the association between the use of epidural analgesia and both a prolonged length of labour and the need for assisted deliveries (i.e. forceps assisted deliveries, vacuum assisted deliveries, and cesarean births). If it is found that providing doula support for women who are eligible for and attempting to have a VBAC reduces or delays the use of epidural analgesia, then it could be hypothesized that doula support for this population may also shorten the length of labour and reduce the need for assisted deliveries, thereby justifying ongoing research in this area.
- Conditions
- Cesarean
- Being tested
- Doula support
- Keywords
- Intrapartum, Clinical trial, Perinatal, Doula, VBAC, Perinatal Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula supportBehavioural
A doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm - D | Experimental | Experimental arm - Women randomized to this arm will receive doula support alongside standard care. Receives: Behavioral: Doula support |
| No intervention - ND | No intervention | No intervention - Women randomized to this arm will receive standard care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of epidural analgesia and cervical dilation at time of epidural administration.
The main outcomes being looked at are use of epidural analgesia and cervical dilation at time of epidural administration. This information will be recorded in the patient charts during the intrapartum period and collected from these charts at a later date by a research assistant.
Secondary outcomes (1)
Cervical dilation at time of epidural administration
The following secondary outcomes will be measured:
- Use of nitrous oxide analgesia during labour.
- Use of narcotic analgesia during labour (type and amount).
- Number of visits to the assessment room before admission.
- Mode of delivery (cesarean section, spontaneous vaginal, or forceps/vacuum).
- Indication(s) for repeat cesarean (if applicable).
- Length of time between admission and the start of active pushing.
- Length of time between the start of active pushing and delivery.
- Length of time between delivery and discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CesareanStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority (PHSA)
- Responsible party
- Sponsor
- Investigators
- Patricia Janssen, BSN, MPH, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216098
- Sponsor's protocol ID
- H10-01551
- Status last verified
- May 2015
- First submitted
- 5 Oct 2010
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Doula Support on Intrapartum Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)
- ClinicalTrials.gov ID
- NCT01216098
- Acronym / sponsor ID
- H10-01551
- Conditions
- Cesarean
- Keywords
- Intrapartum, Clinical trial, Perinatal, Doula, VBAC, Perinatal Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority (PHSA)
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Oct 2010 (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 purpose of this study is to evaluate the impact of doula support on childbirth outcomes of women who are eligible for and attempting to have a Vaginal Birth After Cesarean (VBAC). Doulas are paraprofessionals who provide women with continuous physical and emotional support throughout the course of labour. They also conduct home visits in the prenatal and postpartum periods in order to provide women with information on childbirth-related topics and breastfeeding support. They do not perform clinical tasks. Their value lies in the psycho-social care that they provide. It is hypothesized that women who receive doula support alongside standard care will have a lower rate of epidural analgesia use and greater cervical dilation at time of epidural administration, as compared to those who receive standard care alone.
Detailed description
A two-armed randomized controlled trial will be conducted at BC Women's Hospital. The experimental group will receive both standard clinical care and doula support. The control group will receive standard clinical care without doula support. The main outcomes being looked at are use of epidural analgesia and cervical dilation at time of epidural administration. These outcomes have been chosen because of the association between the use of epidural analgesia and both a prolonged length of labour and the need for assisted deliveries (i.e. forceps assisted deliveries, vacuum assisted deliveries, and cesarean births). If it is found that providing doula support for women who are eligible for and attempting to have a VBAC reduces or delays the use of epidural analgesia, then it could be hypothesized that doula support for this population may also shorten the length of labour and reduce the need for assisted deliveries, thereby justifying ongoing research in this area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm - D | Experimental | Behavioral: Doula supportExperimental arm - Women randomized to this arm will receive doula support alongside standard care. |
| No intervention - ND | No intervention | –No intervention - Women randomized to this arm will receive standard care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who have had at least one prior cesarean birth, are eligible for VBAC, and plan to attempt a VBAC after counseling at the Best Birth Clinic.
- Singleton gestation.
- Cephalic presentation.
- Term gestation (37-42 weeks at time of delivery).
Key exclusion criteria (2 listed)
- Women who have a pre-existing medical condition that would be an indication for an elective cesarean birth.
- Women who plan to privately hire a doula regardless of placement in either arm of the trial.
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 |
|---|---|---|
| Doula supportA doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period. | Behavioural | Experimental arm - D |
Primary outcome
Use of epidural analgesia and cervical dilation at time of epidural administration.
The main outcomes being looked at are use of epidural analgesia and cervical dilation at time of epidural administration. This information will be recorded in the patient charts during the intrapartum period and collected from these charts at a later date by a research assistant.
1 secondary outcome
Cervical dilation at time of epidural administration
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 6 May 2015.
- Related InfoLink provided by the sponsor.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Patricia Janssen, BSN, MPH, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula support in people with Cesarean, run by University of British Columbia 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 4 inclusion and 2 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 6 May 2015. 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?
Use of epidural analgesia and cervical dilation at time of epidural administration.. 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 6 May 2015.