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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Labor Long

Intervention / Treatment
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* Behavioral: Support from a trained companion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Educational; training of lay persons on support during labour
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>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, | Behavioral: Support from a trained companion<br>* Birth companions trained on how to effectively support women during labor<br>|
| Experimental: Arm 2<br>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 | Behavioral: Support from a trained companion<br>* Birth companions trained on how to effectively support women during labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a Spontaneous Vaginal delivery | delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section | labour duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coping and anxiety | Women's self-reported anxiety on admission and after birth will be measured using the 10 cm Visual Analogue Scales Coping with labour will be assessed using the Roberts coping with labour algorithm the midwife looks out for cues for coping and not coping | labour duration | 
| Length of labour | From time of admission (4-6cm) to birth | labour duration | 
| Apgar score | Apgar score of baby at birth | At 1 and 5 minutes | 
| use of oxytocin to augment labor | Use of oxytocin to augment labor | labor duration | 
| Maternal satisfaction questionnaire | Level of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience | Labour duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Support, companion,labour