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

May 5, 2015 updated by: University of British Columbia

Impact of Doula Support on Intrapartum 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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 Outcome Measures

Outcome Measure
Measure Description
Cervical dilation at time of epidural administration

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Provincial Health Services Authority (PHSA)

Investigators

  • Principal Investigator: Patricia Janssen, BSN, MPH, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H10-01551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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