Clinical trial NCT04771325: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Long
Keywords: Support, companion,labour
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2021-02-25
Enrollment: 535
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Educational; training of lay persons on support during labour
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Women with a singleton fetus and a supposed cephalic presentation.
2. 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

Primary outcomes:
measure: Incidence of a Spontaneous Vaginal delivery
timeFrame: labour duration
Secondary outcomes:
measure: coping and anxiety
timeFrame: labour duration
measure: Length of labour
timeFrame: labour duration
measure: Apgar score
timeFrame: At 1 and 5 minutes
measure: use of oxytocin to augment labor
timeFrame: labor duration
measure: Maternal satisfaction questionnaire
timeFrame: Labour duration
Other outcomes:
Locations:
city: Mbale
country: Uganda
facility: Mbale Regional Referral Hospital
Study officials:
affiliation: Makerere University
name: Gorrette Nalwadda, PhD
role: STUDY_CHAIR
References: