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

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Long
• Intervention / Treatment: Behavioral: Support from a trained companion

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 Type: Interventional
• Enrollment (Anticipated): 535
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Wodeya Wanyenze, Master of Nursing (Midwifery); Phone Number: +256772651333 256772651333; Email: ewanyenze@must.ac.ug
• Study Contact Backup: Name: Gorrette Nalwadda, PhD; Phone Number: 0782387865; Email: gnalwadda@gmail.com

Study Locations

• Uganda
  • Mbale, Uganda, +256
    • Recruiting
    • Mbale Regional Referral Hospital
    • Contact: Kenneth Mugabe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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,	Behavioral: Support from a trained companion; Birth companions trained on how to effectively support women during labor
Experimental: 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	Behavioral: Support from a trained companion; Birth companions trained on how to effectively support women during labor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Makerere University
• Collaborators: Swedish International Development Cooperation Agency (SIDA)
• Investigators: Study Chair: Gorrette Nalwadda, PhD, Makerere University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Support, companion,labour
• Other Study ID Numbers: 2017-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No