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Completed

NCT Number: NCT01216098

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.

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Key information

Conditions

Cesarean

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doula support

Behavioral

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

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

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Provincial Health Services Authority (PHSA)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Oct 7, 2010
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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