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

Sponsor
Makerere University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04771325
Collaborator
Swedish International Development Cooperation Agency (SIDA) (Other)
535
1
2
20
26.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Support from a trained companion
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
535 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Educational; training of lay persons on support during labourEducational; training of lay persons on support during labour
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Dec 30, 2019
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Aug 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of a Spontaneous Vaginal delivery [labour duration]

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

Secondary Outcome Measures

  1. coping and anxiety [labour duration]

    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

  2. Length of labour [labour duration]

    From time of admission (4-6cm) to birth

  3. Apgar score [At 1 and 5 minutes]

    Apgar score of baby at birth

  4. use of oxytocin to augment labor [labor duration]

    Use of oxytocin to augment labor

  5. Maternal satisfaction questionnaire [Labour duration]

    Level of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mbale Regional Referral Hospital Mbale Uganda +256

Sponsors and Collaborators

  • Makerere University
  • Swedish International Development Cooperation Agency (SIDA)

Investigators

  • Study Chair: Gorrette Nalwadda, PhD, Makerere University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Makerere University
ClinicalTrials.gov Identifier:
NCT04771325
Other Study ID Numbers:
  • 2017-54
First Posted:
Feb 25, 2021
Last Update Posted:
Feb 25, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Makerere University

Study Results

No Results Posted as of Feb 25, 2021