Impact of Doula Support on Childbirth 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impact of Doula Support on Intrapartum Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)|
- 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.
- Cervical dilation at time of epidural administration [ Designated as safety issue: Yes ]
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.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Experimental arm - D
Experimental arm - Women randomized to this arm will receive doula support alongside standard care.
Behavioral: Doula support
A doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period.
No Intervention: No intervention - ND
No intervention - Women randomized to this arm will receive standard care alone.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216098
|Contact: Patricia Janssen, BSN, MPH, PhD||604-875-2424 ext email@example.com|
|Contact: Lee Saxell, RM, MA||604-875-2000 ext firstname.lastname@example.org|
|Canada, British Columbia|
|BC Women's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Contact: Patricia Janssen, BSN, MPH, PhD 604-875-2424 ext 5415 email@example.com|
|Contact: Lee Saxell, RM, MA 604-875-2000 ext 6387 firstname.lastname@example.org|
|Principal Investigator: Patricia Janssen, BSN, MPH, PhD|
|Sub-Investigator: Lee Saxell, RM, MA|
|Principal Investigator:||Patricia Janssen, BSN, MPH, PhD||University of British Columbia|