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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04771325
Enrollment
535
Registered
2021-02-25
Start date
2019-12-30
Completion date
2021-08-30
Last updated
2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Long

Keywords

Support, companion,labour

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.

Interventions

BEHAVIORALSupport from a trained companion

Birth companions trained on how to effectively support women during labor

Sponsors

Swedish International Development Cooperation Agency (SIDA)
CollaboratorOTHER_GOV
Makerere University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Educational; training of lay persons on support during labour

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of a Spontaneous Vaginal deliverylabour durationdelivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section

Secondary

MeasureTime frameDescription
coping and anxietylabour durationWomen'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
Length of labourlabour durationFrom time of admission (4-6cm) to birth
Apgar scoreAt 1 and 5 minutesApgar score of baby at birth
use of oxytocin to augment laborlabor durationUse of oxytocin to augment labor
Maternal satisfaction questionnaireLabour durationLevel of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience

Countries

Uganda

Contacts

Primary ContactEva Wodeya Wanyenze, Master of Nursing (Midwifery)
ewanyenze@must.ac.ug256772651333
Backup ContactGorrette Nalwadda, PhD
gnalwadda@gmail.com0782387865

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026