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Impact of Doula Support on Childbirth Outcomes for Women Undergoing a Vaginal Birth After Cesarean (VBAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Provincial Health Services Authority (PHSA)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01216098
First received: October 5, 2010
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Cesarean
Behavioral: Doula support

Study Type: Interventional
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)

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 75
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216098

Locations
Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Provincial Health Services Authority (PHSA)
Investigators
Principal Investigator: Patricia Janssen, BSN, MPH, PhD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01216098     History of Changes
Other Study ID Numbers: H10-01551
Study First Received: October 5, 2010
Last Updated: September 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Intrapartum
Clinical trial
Perinatal
Doula
VBAC
Perinatal Outcomes

ClinicalTrials.gov processed this record on November 20, 2014