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

Cesarean Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216098
• Other study ID #: H10-01551
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: May 5, 2015
• Start date: October 2010
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean

Intervention

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

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Provincial Health Services Authority (PHSA)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Yes
Secondary	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.		Yes

External Links

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