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

NCT ID: NCT04771325

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-30

Study Completion Date

2021-08-30

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.

Conditions

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Labor Long

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Educational; training of lay persons on support during labour
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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,

Group Type OTHER

Support from a trained companion

Intervention Type BEHAVIORAL

Birth companions trained on how to effectively support women during labor

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

Group Type EXPERIMENTAL

Support from a trained companion

Intervention Type BEHAVIORAL

Birth companions trained on how to effectively support women during labor

Interventions

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Support from a trained companion

Birth companions trained on how to effectively support women during labor

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish International Development Cooperation Agency (SIDA)

OTHER_GOV

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gorrette Nalwadda, PhD

Role: STUDY_CHAIR

Makerere University

Locations

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Mbale Regional Referral Hospital

Mbale, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Eva Wodeya Wanyenze, Master of Nursing (Midwifery)

Role: CONTACT

256772651333 ext. +256772651333

Gorrette Nalwadda, PhD

Role: CONTACT

0782387865

Facility Contacts

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Kenneth Mugabe

Role: primary

References

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Wanyenze EW, Nalwadda GK, Tumwesigye NM, Byamugisha JK. Efficacy of midwife-led role orientation of birth companions on maternal satisfaction and birth outcomes: a randomized control trial in Uganda. BMC Pregnancy Childbirth. 2023 Sep 18;23(1):669. doi: 10.1186/s12884-023-05978-8.

Reference Type DERIVED
PMID: 37723430 (View on PubMed)

Other Identifiers

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2017-54

Identifier Type: -

Identifier Source: org_study_id

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