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

NCT01216098 | Completed DMC

• 1 other identifier: H10-01551
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean

Keywords

Intrapartum; Clinical trial; Perinatal; Doula; VBAC; Perinatal Outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental arm - D

EXPERIMENTAL

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

Behavioral: Doula support

No intervention - ND

NO INTERVENTION

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

Interventions

Doula support BEHAVIORAL

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

Experimental arm - D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Provincial Health Services Authority (PHSA): collaborator

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Links

• Related Info

Study Officials

• Patricia Janssen, BSN, MPH, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

CA (1)