Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202503666794479 Date of Registration: 17/03/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role oriented labor companions’ intrapartum support to improve maternal satisfaction and birth outcomes
Official scientific title Implementation of role oriented labor companion continuous intrapartum support to improve maternal satisfaction and birth outcomes in childbearing women: A cluster randomized control trial
Brief summary describing the background and objectives of the trial Improving the quality of care around the time of birth has been acknowledged as the most impactful strategy for reducing stillbirths and maternal and newborn deaths. A woman’s emotional and cognitive experience of birth has a significant impact on her physical and psychological state. The process of labor comprises a great amount of physiological and psychological stress. The World Health Organization (WHO) recommends that every woman be supported continuously throughout labor by a companion of choice. Continuous labor companion support is defined as the presence of a trained professional or layperson or family members at the bedside of a parturient women to coach, empathize with, give practical aid to, and inform the expectant mother about birthing. Labor companionship, like other non-clinical interventions, has not been regarded as a priority in many settings, yet it is an essential component of the experience of care, Several barriers have been identified in the implementation of the presence of a companion of choice at birth in resource-strained hospital settings. Amongst these is the absence of clear communication with the companion about their roles companions’ lack of confidence and clarity about their role may lead to a sense of powerlessness when a woman is in pain. Presently, women in Ethiopia are allowed to have a companion of choice during labor. These companions, however, neither receive an orientation nor have defined roles and responsibilities. It is acknowledged that actively involving family members in the process of labor ensures ownership and engagement. Therefore, this study aimed to assess the effect of role oriented labor companions’ support on reducing psychological birth trauma and adverse birth outcomes. We hypothesized that giving an orientation to women’s labor companion of choice increases positive child birth experience and improve birth outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 04/02/2023
Actual trial start date 23/12/2023
Anticipated date of last follow up 14/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 440
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Role orientation of labor companions during antenatal period 5 Times 18 months Intervention groups: The intervention is “Role orientation of labor companions during antenatal period”. The chosen labor companion of choice is provided orientation session on how to provide continuous intrapartum support and roles and responsibility of labor companions during intrapartum period. We assume that providing an orientation session is likely to boost labor companion confidence, hence increasing the effectiveness of continuous support. The content for the orientation session consisted of providing emotional, informational, communication and physical supports. Emotional support included being present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, and praise, and encouraging and acknowledging efforts. Physical support included supporting her to change positions favoring upright positions, walking with her, giving her drinks and food, massaging, reminding her to go and pass urine, helping her find a comfortable position for pushing, and wiping her face with a cool cloth. Informational includes talking and knowing the progress of labor with the mother and health care providers and communication means paraphrasing the women’s need and talk on behave of the women with health care providers. The content is developed based on the literature on labor companionship techniques. This orientation is integrated into the antenatal care of the woman and lasted about 20 min. After labor is confirmed, in addition to the routine orientation procedure, the health provider explain to the labor companion the different support techniques and clarified what is expected of them. Each task is explained in simple terms and local language with image/picture, including why the task is important and how it is performed, then labor companions are shown how it is performed, with return demonstrations from the companion. This is repeated for the labor companion to grasp and retain the task Control (usual care) groups : Women 220
Control Group Usual care 5 Times 18months Control (usual care) groups : Women are escorted to the health facilities by one or more family members or friends. One person is allowed, besides her, to provide support. The support persons do not receive any orientation sessions and have no designated roles. Routine care is given. Health care providers provide skilled care as usual. 220 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for pregnant women *Primigravida *single pregnancy *First trimester pregnancy *Low-risk pregnancy Having desire to receive labor companion intrpartum period support Inclusion for labor companion of choice *Willing to accompanying the mother to the health facility during antenatal period, intranatal period and immediate postpartum period. *Chosen by the women *Having the ability to communicate verbally Exclusion criteria *Multiparous women *Multiple pregnancy *High risk pregnancy *Do not have desire to be a companion Adult: 18 Year(s)-44 Year(s) 19 Year(s) 44 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/12/2023 Addis Ababa Health Bureau
Ethics Committee Address
Street address City Postal code Country
Meganegna Addis Ababa 1000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcomes Companions level of adherence to continuous intrapartum support Level of psychological birth trauma Adverse birth outcomes (Still birth, Lowbirth weight, preterm birth etc) At the end of the intervention
Secondary Outcome Number of cesarean section births , Number of spontaneous vaginal delivery , Level of maternal satisfaction At the end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Public Health Facilities such as Arada Kirkos Lideta Bole AKaki Gulele Kolfe Addis ketema Lemikura Lafto and Yeka Addis Ababa Addis Ababa 1000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Jimma main campus Jimma 1000 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MeKelle University Ayder campus Mekelle 1000 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gedamu Zegeye gedamuabera@yahoo.com +251977812857 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Mekele University
Role Name Email Phone Street address
Public Enquiries Gedamu Zegeye gedamuabera@yahoo.com +251977812857 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Lecturer and researcher
Role Name Email Phone Street address
Scientific Enquiries Gedamu Zegeye gedamuabera@yahoo.com +251977812857 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1000 Ethiopia Lecturer and researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 13/03/2025 Comments from reviewer Improving the quality of care around the time of birth has been acknowledged as the most impactful strategy for reducing stillbirths and maternal and newborn deaths. A woman’s emotional and cognitive experience of birth has a significant impact on her physical and psychological state. The process of labor comprises a great amount of physiological and psychological stress. The World Health Organization (WHO) recommends that every woman be supported continuously throughout labor by a companion of choice. Continuous labor companion support is defined as the presence of a trained professional or layperson or family members at the bedside of a parturient women to coach, empathize with, give practical aid to, and inform the expectant mother about birthing. The labor companion in this context can be any person chosen by the woman to provide her with continuous intrapartum support Labor companionship, like other non-clinical interventions, has not been regarded as a priority in many settings, yet it is an essential component of the experience of care . Several barriers have been identified in the implementation of the presence of a companion of choice at birth in resource-strained hospital settings. Amongst these is the absence of clear communication with the companion about their roles Companions’ lack of confidence and clarity about their role may lead to a sense of powerlessness when a woman is in pain. For implementation purposes, WHO recommends that labor companions have an orientation session on supportive labor companionship techniques. This is to ensure that their presence is beneficial to both the woman and her health care providers. Presently, women in Ethiopia are allowed to have a companion of choice during labor. These companions, however, neither receive an orientation nor have defined roles and responsibilities. It is acknowledged that actively involving family members in the process of labor ensures ownership and engagement. There is low-quality evidence Improving the quality of care around the time of birth has been acknowledged as the most impactful strategy for reducing stillbirths and maternal and newborn deaths. A woman’s emotional and cognitive experience of birth has a significant impact on her physical and psychological state. The process of labor comprises a great amount of physiological and psychological stress. The World Health Organization (WHO) recommends that every woman be supported continuously throughout labor by a companion of choice. Continuous labor companion support is defined as the presence of a trained professional or layperson or family members at the bedside of a parturient women to coach, empathize with, give practical aid to, and inform the expectant mother about birthing. Labor companionship, like other non-clinical interventions, has not been regarded as a priority in many settings, yet it is an essential component of the experience of care, Several barriers have been identified in the implementation of the presence of a companion of choice at birth in resource-strained hospital settings. Amongst these is the absence of clear communication with the companion about their roles companions’ lack of confidence and clarity about their role may lead to a sense of powerlessness when a woman is in pain. Presently, women in Ethiopia are allowed to have a companion of choice during labor. These companions, however, neither receive an orientation nor have defined roles and responsibilities. It is acknowledged that actively involving family members in the process of labor ensures ownership and engagement. Therefore, this study aimed to assess the effect of role oriented labor companions’ support on reducing psychological birth trauma and adverse birth outcomes. We hypothesized that giving an orientation to women’s labor companion of choice increases positive child birth experience and improve birth outcome.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 13/03/2025 Error in selecting from the calendar 31 Mar 2024 04 Feb 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 13/03/2025 PACTR Admin 31 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 13/03/2025 Permission was obtained from Addis Ababa health Bureau to each health facilities on 23/12/23. We attached letter 31 Mar 2024 23 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/03/2025 Miscalcualtion Control Group, Usual care , 5 Times , 18months , Control (usual care) groups : Women are escorted to the health facilities by one or more family members or friends. One person is allowed, besides her, to provide support. The support persons do not receive any orientation sessions and have no designated roles. Routine care is given. Health care providers provide skilled care as usual. , 220, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/03/2025 Error/ Miscalculation Experimental Group, Role orientation of labor companions during antenatal period, 5 Times , 12 months , Intervention groups: The intervention is “Role orientation of labor companions during antenatal period”. The chosen labor companion of choice is provided orientation session on how to provide continuous intrapartum support and roles and responsibility of labor companions during intrapartum period. We assume that providing an orientation session is likely to boost labor companion confidence, hence increasing the effectiveness of continuous support. The content for the orientation session consisted of providing emotional, informational, communication and physical supports. Emotional support included being present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, and praise, and encouraging and acknowledging efforts. Physical support included supporting her to change positions favoring upright positions, walking with her, giving her drinks and food, massaging, reminding her to go and pass urine, helping her find a comfortable position for pushing, and wiping her face with a cool cloth. Informational includes talking and knowing the progress of labor with the mother and health care providers and communication means paraphrasing the women’s need and talk on behave of the women with health care providers. The content is developed based on the literature on labor companionship techniques. This orientation is integrated into the antenatal care of the woman and lasted about 20 min. After labor is confirmed, in addition to the routine orientation procedure, the health provider explain to the labor companion the different support techniques and clarified what is expected of them. Each task is explained in simple terms and local language with image/picture, including why the task is important and how it is performed, then labor companions are shown how it is performed, with return demonstrations from the companion. This is repeated for the labor companion to grasp and retain the task Control (usual care) groups : Women , 220, Experimental Group, Role orientation of labor companions during antenatal period, 5 Times , 18 months , Intervention groups: The intervention is “Role orientation of labor companions during antenatal period”. The chosen labor companion of choice is provided orientation session on how to provide continuous intrapartum support and roles and responsibility of labor companions during intrapartum period. We assume that providing an orientation session is likely to boost labor companion confidence, hence increasing the effectiveness of continuous support. The content for the orientation session consisted of providing emotional, informational, communication and physical supports. Emotional support included being present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, and praise, and encouraging and acknowledging efforts. Physical support included supporting her to change positions favoring upright positions, walking with her, giving her drinks and food, massaging, reminding her to go and pass urine, helping her find a comfortable position for pushing, and wiping her face with a cool cloth. Informational includes talking and knowing the progress of labor with the mother and health care providers and communication means paraphrasing the women’s need and talk on behave of the women with health care providers. The content is developed based on the literature on labor companionship techniques. This orientation is integrated into the antenatal care of the woman and lasted about 20 min. After labor is confirmed, in addition to the routine orientation procedure, the health provider explain to the labor companion the different support techniques and clarified what is expected of them. Each task is explained in simple terms and local language with image/picture, including why the task is important and how it is performed, then labor companions are shown how it is performed, with return demonstrations from the companion. This is repeated for the labor companion to grasp and retain the task Control (usual care) groups : Women , 220,
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/03/2025 Cooments from reviewer Public Health Facilities , Addis Ababa, Addis Ababa, 1000, Ethiopia Public Health Facilities such as Arada Kirkos Lideta Bole AKaki Gulele Kolfe Addis ketema Lemikura Lafto and Yeka , Addis Ababa, Addis Ababa, 1000, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/03/2025 Cooments from reviewer Public Health Facilities such as Arada Kirkos Lideta Bole AKaki Gulele Kolfe Addis ketema Lemikura Lafto and Yeka , Addis Ababa, Addis Ababa, 1000, Ethiopia Public Health Facilities such as Arada Kirkos Lideta Bole AKaki Gulele Kolfe Addis ketema Lemikura Lafto and Yeka , Addis Ababa, Addis Ababa, 1000, Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/03/2025 Comment from reviewer TRUE, Jimma University Institutional Review Board , Jimma, Oromia, Jimma, 1000, Ethiopia, , 11 Aug 2022, +251471111457, ethicsjuirb@gmail.com, 33509_30631_4737.pdf TRUE, Addis Ababa Health Bureau , Meganegna , Addis Ababa, 1000, Ethiopia, , 23 Dec 2023, +251111234272, ethicsaahb@gmail.com, 33509_30631_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/03/2025 Comment from reviewer TRUE, Addis Ababa Health Bureau , Meganegna , Addis Ababa, 1000, Ethiopia, , 23 Dec 2023, +251111234272, ethicsaahb@gmail.com, 33509_30631_4737.pdf TRUE, Addis Ababa Health Bureau , Meganegna , Addis Ababa, 1000, Ethiopia, , 23 Dec 2023, +251111234272, ethicsaahb@gmail.com, 33509_30631_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 13/03/2025 Comment from reviewer Yes IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).