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

Labor Long Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771325
• Other study ID #: 2017-54
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: February 2021
• Source: Makerere University
• Contact: Eva Wodeya Wanyenze, Master of Nursing (Midwifery)
• Phone: 256772651333
• Email: ewanyenze[@]must.ac.ug
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 535
• Est. completion date: August 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Long

Intervention

Behavioral:
• Support from a trained companion
Birth companions trained on how to effectively support women during labor

Locations

Country	Name	City	State
Uganda	Mbale Regional Referral Hospital	Mbale

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Swedish International Development Cooperation Agency (SIDA)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a Spontaneous Vaginal delivery	delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section	labour duration
Secondary	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
Secondary	Length of labour	From time of admission (4-6cm) to birth	labour duration
Secondary	Apgar score	Apgar score of baby at birth	At 1 and 5 minutes
Secondary	use of oxytocin to augment labor	Use of oxytocin to augment labor	labor duration
Secondary	Maternal satisfaction questionnaire	Level of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience	Labour duration