Impact of Doula Support on Childbirth Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)
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| First Received Date ICMJE | October 5, 2010 | ||||||||
| Last Updated Date | December 20, 2012 | ||||||||
| Start Date ICMJE | October 2010 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Use of epidural analgesia and cervical dilation at time of epidural administration. [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01216098 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Cervical dilation at time of epidural administration [ Designated as safety issue: Yes ] The following secondary outcomes will be measured:
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of Doula Support on Childbirth Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC) | ||||||||
| Official Title ICMJE | Impact of Doula Support on Intrapartum Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC) | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Cesarean | ||||||||
| Intervention ICMJE | Behavioral: Doula support
A doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 534 | ||||||||
| Estimated Completion Date | May 2014 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01216098 | ||||||||
| Other Study ID Numbers ICMJE | H10-01551 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of British Columbia | ||||||||
| Study Sponsor ICMJE | University of British Columbia | ||||||||
| Collaborators ICMJE | Provincial Health Services Authority (PHSA) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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