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.: PACTR202510702645961 Date of Registration: 07/10/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Companionship in Labor on Maternal and Fetal Outcome Among Parturient at Jos University Teaching Hospital: A Randomized Controlled Trial
Official scientific title The Effect of Companionship in Labor on Maternal and Fetal Outcome Among Parturient at Jos University Teaching Hospital: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial BACKGROUND: Childbirth is a pivotal event in women's lives, emphasizing the importance of positive maternal and fetal outcomes. A labour companion offers continuous care during labour, potentially improving outcomes. However, its impact remains understudied in Nigerian healthcare settings. Hence the need to assess the impact of companionship in labour among parturients OBJECTIVE: To assess the effect of companionship in labour on maternal and fetal outcome among parturients at Jos University Teaching Hospital.
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 06/01/2025
Actual trial start date 06/01/2025
Anticipated date of last follow up 30/08/2025
Actual Last follow-up date 30/07/2025
Anticipated target sample size (number of participants) 174
Actual target sample size (number of participants) 160
Recruitment status Completed
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Did not receive doula support i.e routine intrapartum care during active phase of labour They received the routine care during labour 80 Active-Treatment of Control Group
Experimental Group doula support during active phase of labor For women in the intervention group, emotional support will be provided by the trained labour companions (doula), including the use of encouraging phrases about the nature of labour pain, the effect of pain intensity on the progress of labour, touching and massaging the mothers' back, answering mothers' questions about the progress and success of delivery, and providing essential education during labour (such as how to breathe and correct positioning in different stages). Additionally, physical support will be offered by the doula, including helping the mothers to change their position, accompanying the mother, and assisting with the need to move out of bed. In contrast, women in the control group (without doula support) will only receive routine care. 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women admitted for vaginal delivery at Jos University Teaching Hospital. 2. Gestational age 37-42 weeks 3. Singleton pregnancy. 4. Low-risk pregnancy, defined as absence of significant medical or obstetric complications such as hypertension, diabetes, or placenta previa. 4.6 EXCLUSION CRITERIA 1. Multiple gestation (e.g., twins, triplets). 2. High-risk pregnancy, including but not limited to pre-eclampsia, gestational diabetes, placental abnormalities, or foetal anomalies. 3. Planned caesarean section. 4. Inability to provide informed consent due to cognitive impairment or language barrier, or those that declined consent? 5. Any condition that, in the judgment of the attending obstetrician, would preclude participation in the study or compromise the safety of the mother or baby. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 45 Year(s) Female
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 11/06/2024 JUTH Health Research Committe
Ethics Committee Address
Street address City Postal code Country
lamingo Jos PMB 2076 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure for this study will be the duration of active phase labour time elapsed from the onset of regular, painful contractions with cervical dilation of 4 centimeters until full cervical dilation of 10 centimeters.
Secondary Outcome Secondary outcome measures will include the duration of the second stage of labour, the time from full cervical dilation to the delivery of the baby.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital Lamingo Jos PMB 2076 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mary Musa Rayfield Jos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self sponsored rayfield jos Nigeria Self Sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MARY MEMUNA MUSA mary.m.musa00@gmail.com +2348030642826 rayfield
City Postal code Country Position/Affiliation
jos Nigeria Resident in Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Jos University Teaching Hospital Health Research Ethical Committee info@juth.org.ng +2349030001194 lamingo
City Postal code Country Position/Affiliation
jos plateau state PMB 2076 Nigeria Ethical chairman
Role Name Email Phone Street address
Scientific Enquiries Amaka Ngozi Ockeke amakaocheke@yahoo.com +2348036135114 State lowcost
City Postal code Country Position/Affiliation
Jos plateau state Nigeria Research Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data (IPD) will be shared by widespread third party access to the IPD and associated documentation from the trial. The sharing shall be fully Open. The following methods will be used; * utilizing of data sharing platforms and repositories * making data accessible through data sharing statements in clinical trial registries. Informed Consent Form,Statistical Analysis Plan,Study Protocol 3years open
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 Public title 29/09/2025 Typographic error THE EFFECT OF COMPANIONSHIP IN LABOUR ON MATERNAL AND FETAL OUTCOMES AMONG PARTURIENTS AT JOS UNIVERSITY TEACHING HOSPITAL: A RANDOMISED CONTROLLED TRIAL The Effect of Companionship in Labor on Maternal and Fetal Outcome Among Parturient at Jos University Teaching Hospital: A Randomized Controlled Trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 29/09/2025 Typographic error THE EFFECT OF COMPANIONSHIP IN LABOUR ON MATERNAL AND FETAL OUTCOMES AMONG PARTURIENTS AT JOS UNIVERSITY TEACHING HOSPITAL: A RANDOMISED CONTROLLED TRIAL The Effect of Companionship in Labor on Maternal and Fetal Outcome Among Parturient at Jos University Teaching Hospital: A Randomized Controlled Trial
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 29/09/2025 error during uploading Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/09/2025 typographic error Control Group, doula support, , during active phase of labour, They received the routine care during labour , 80, Active-Treatment of Control Group Control Group, Did not receive doula support i.e routine intrapartum care, , during active phase of labour, They received the routine care during labour , 80, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/09/2025 previous ethical clearance wasn't legible TRUE, JUTH Health Research Committe, lamingo, Jos, PMB 2076, Nigeria, , 11 Jun 2024, +2349030001194, info@juth.org.ng, 37137_34322_4737.pdf TRUE, JUTH Health Research Committe, lamingo, Jos, PMB 2076, Nigeria, , 11 Jun 2024, +2349030001194, info@juth.org.ng, 37137_34322_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 29/09/2025 error in entering name of funding sources Self , Rayfield , Jos, , Nigeria, Self Funded, Dr. Mary Musa, Rayfield , Jos, , Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 29/09/2025 initial response wasn't correct A total of 174 women were assessed for eligibility, of which 160 met the inclusion criteria and were randomised equally into two groups: 80 received doula-supported care, and 80 received routine care. All participants in both groups received their allocated interventions. There were no losses to follow-up or exclusions from analysis, and data from all 160 participants were included in the final analysis. The two groups were similar in their sociodemographic and obstetric characteristics,There was no significant difference in the age group distribution between the two groups (p = 0.670). Educational levels showed a marginal trend towards statistical significance, with more participants in the primary education category receiving doula care, although this was not significant overall (p = 0.056). Parity distribution did not differ significantly between groups (p = 0.338), and the median gestational age at delivery was 39.0 weeks (IQR = 2.0) in both groups (p = 0.374). Booking status and the onset of labour were also similar across groups, with no statistically significant differences noted (p = 0.620 and p = 0.719, respectively). The median cervical dilatation at admission was 6.0 cm in both groups (IQR = 1.0), with no significant difference (p = 0.622). Labour and delivery outcomes are presented in Table 2. The median duration of the active phase of labour was 207.0 minutes (IQR = 174.5) in the doula care group and 195.0 minutes (IQR = 133.0) in the routine care group, with no significant difference (p = 0.231). The individual participant data (IPD) will be shared by widespread third party access to the IPD and associated documentation from the trial. The sharing shall be fully Open. The following methods will be used; * utilizing of data sharing platforms and repositories * making data accessible through data sharing statements in clinical trial registries.