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

NCT ID: NCT01216098

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental arm - D

Experimental arm - Women randomized to this arm will receive doula support alongside standard care.

Group Type: EXPERIMENTAL

Doula support

Intervention Type: BEHAVIORAL

A doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period.

No intervention - ND

No intervention - Women randomized to this arm will receive standard care alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Doula support

A doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Provincial Health Services Authority (PHSA)

UNKNOWN

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Janssen, BSN, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Women's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Related Links

http://www.powertopush.ca/info-for-professionals/more-about-the-campaign/

Related Info

Other Identifiers

H10-01551

Identifier Type: -

Identifier Source: org_study_id