Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Makerere University
- Enrollment
- 535
- Locations
- 1
- Primary Endpoint
- Incidence of a Spontaneous Vaginal delivery
Study Overview
Brief Summary
A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental group. Events and outcomes will then be assessed during and after birth.
Detailed Description
The order of introduction of the intervention will be determined randomly. Control data will be obtained from the first health facility until the sample size for the control for that facility is achieved. Following collection of control data for the first facility, the intervention will be introduced to the same facility to a new group of participants. Simultaneously control data from the other facilities will be collected and this will be done until all the facilities are covered in a step wedge manner.
The intervention will consist of a session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women with a singleton fetus and a supposed cephalic presentation.
- •Women with a female friend or relative willing to stay with them through the process of labor and birth.
Exclusion Criteria
- •Women with a multiple pregnancy.
- •Women with a previous cesarean section
- •Women who are mentally incapacitated or deaf and dumb
Arms & Interventions
Arm 1
Women are normally escorted to the health facilities by one or more family members and or friends. Women usually labor in an open first stage room where more than one woman is admitted sometimes with curtains to separate the beds with one person allowed besides her to provide support. The support persons do not have designated roles to play during this process. Routine analgesia is not given neither is continuous fetal monitoring. Midwives,
Intervention: Support from a trained companion (Behavioral)
Arm 2
One session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed
Intervention: Support from a trained companion (Behavioral)
Outcomes
Primary Outcomes
Incidence of a Spontaneous Vaginal delivery
Time Frame: labour duration
delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section
Secondary Outcomes
- Length of labour(labour duration)
- Apgar score(At 1 and 5 minutes)
- coping and anxiety(labour duration)
- use of oxytocin to augment labor(labor duration)
- Maternal satisfaction questionnaire(Labour duration)