NCT04771325

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
535

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

February 23, 2021

Last Update Submit

February 24, 2021

Conditions

Labor Long

Keywords

Support, companion,labour

Outcome Measures

Primary Outcomes (1)

  • Incidence of a Spontaneous Vaginal delivery

    delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section

    labour duration

Secondary Outcomes (5)

  • coping and anxiety

    labour duration

  • Length of labour

    labour duration

  • Apgar score

    At 1 and 5 minutes

  • use of oxytocin to augment labor

    labor duration

  • Maternal satisfaction questionnaire

    Labour duration

Study Arms (2)

Arm 1

OTHER

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

Arm 2

EXPERIMENTAL

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

Interventions

Support from a trained companionBEHAVIORAL

Birth companions trained on how to effectively support women during labor

Arm 1Arm 2

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Women with a multiple pregnancy.
  • Women with a previous cesarean section
  • Women who are mentally incapacitated or deaf and dumb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbale Regional Referral Hospital

Mbale, +256, Uganda

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37723430DERIVED

Study Officials

  • Gorrette Nalwadda, PhD

    Makerere University

    STUDY CHAIR

Central Study Contacts

Eva Wodeya Wanyenze, Master of Nursing (Midwifery)

CONTACT

256772651333ewanyenze@must.ac.ug

Gorrette Nalwadda, PhD

CONTACT

0782387865gnalwadda@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Educational; training of lay persons on support during labour
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 25, 2021

Study Start

December 30, 2019

Primary Completion

June 30, 2021

Study Completion

August 30, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

UG(1)