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.: PACTR202505660094613 Date of Registration: 27/05/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Use of perineal warm compress during second stage of labour in reducing perineal trauma in nullipara in Enugu, Nigeria: A randomized controlled trial.
Official scientific title Use of perineal warm compress during the second stage of labour in reducing perineal trauma in nullipara in Enugu, Nigeria: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Background: Perineal trauma is a common complication associated with most vaginal.births. It is categorized into four major types by the extent of injury sustained to the perineum, skin, perineal muscle, labia, clitoris, urethra and anal sphincter. Preventing or minimizing perineal trauma is part of the global effort to ensure women have a positive birth experience. Objectives- To compare the effect of warm compress in the second stage of labour on the perineum as against standard hands- off in reducing perineal trauma in nullipara.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Nil
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 14/08/2024
Actual trial start date 05/09/2024
Anticipated date of last follow up 05/09/2024
Actual Last follow-up date 25/03/2025
Anticipated target sample size (number of participants) 186
Actual target sample size (number of participants) 182
Recruitment status Completed
Publication URL Nil
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Warm compress Minimum of 3 1-3 minutes Warm compress was applied on the perineum of the woman at active second stage of labour with each uterine contraction with water temperature ranging from 38 to 42 degrees Celsius. A minimum of 3 warm compress was applied to the perineum. 93
Experimental Group Warm compress A minimum of three In between contractions The warm compress was a perineal pad soaked in warm water (temperature of 45-50 degrees Celsius) within a bowl, squeezed to remove excess water, with the pad temperature ranging between 38-42 degrees Celsius was placed gently on the perineum between and through contractions when the parturient was in active phase of the second stage of labour. 90
Control Group No warm compress Nil Nil The partiurient was monitored during the active phase of the second stage of labour according to the standard of care for delivery in the hospital. 92 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primigravida from 37weeks gestational age Uncomplicated singleton pregnancy Cephalic presentation Contraindications to vaginal delivery Informed consent for participation Pregnancy before 37weeks Multiple pregnancy Previous caesarean section Malpresentation Abruptio place at Placenta praevia Elderly primigravida Preeclampsia Sickle cell disease Adult: 18 Year(s)-44 Year(s) 18 Year(s) 34 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 27/02/2024 University of Nigeria Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Ituku-ozalla, Enugu Enugu 040004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of women that had perineal trauma in the intervention group versus the control group. After delivery
Secondary Outcome To compare the degree of pain between the women who had warm compress and those that did not have 30minutes and 24 hours after delivery respectively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tertiary hospital in Enugu Ituku-ozalla, parklane, ogui road Enugu 0040001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Edegware Ifeoma Uwani, Enugu Enugu 040004 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Edegware Ifeoma Uwani, Enugu Enugu 040004 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Ezugwu C. Euzebus Ituku-Ozalla Enugu 04004 Nigeria
Prof. Chigbu O. Chibuike Ituku-Ozalla Enugu 04004 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeoma Edegware brifyede27@gmail.com +2348032504990 Uwani, Enugu
City Postal code Country Position/Affiliation
Enugu 04004 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Ifeoma Edegware brifyede27@gmail.com +2348032504990 Uwani, Enugu
City Postal code Country Position/Affiliation
Enugu 04004 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Euzebus Ezugwu euzebus.ezugwu@unn.edu.ng +2348037020295 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 04004 Nigeria Director Institute of Maternal and Child Health University of NIgeria Nsukka
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I am willing to share my raw data. PROFORMA Name Age Marital status Occupation Ethnicity Educational status Intervention Time of commencement of intervention How many times intervention was done Time of delivery Mode of delivery Perineal trauma -Yes No If yes First degree Second degree Third degree Fourth degree Suturing Yes No Estimated blood loss Pain score Maternal satisfaction score Neonatal outcome- APGAR score in 1 minute APGAR score in 5 minutes Birthweight Newborn special care unit admission- Yes No Informed Consent Form From time of admission of patient into the labour ward in active phase of labour to discharge Open acess
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
Ethics Ethics List 15/05/2025 Thank you for the review. The letter was dated 27th February 2024, however was duly signed by the committee on 5th March 2024. That was the reason for putting the approval date as 5th March initially. This has been corrected above TRUE, University of Nigeria Teaching Hospital Ethical Committee, Ituku-ozalla, Enugu, Enugu, 040004, Nigeria, , 05 Mar 2024, +2348037020295, info@unth.edu.ng, 34687_31878_4737.pdf TRUE, University of Nigeria Teaching Hospital Ethical Committee, Ituku-ozalla, Enugu, Enugu, 040004, Nigeria, , 27 Feb 2024, +2348037020295, info@unth.edu.ng, 34687_31878_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 15/05/2025 The proforma for the study has been inserted Proforma which included the sociodemographics of the patient, the type of intervention carried out, the outcome, visual analogue scale and a maternal satisfaction scale PROFORMA Name Age Marital status Occupation Ethnicity Educational status Intervention Time of commencement of intervention How many times intervention was done Time of delivery Mode of delivery Perineal trauma -Yes No If yes First degree Second degree Third degree Fourth degree Suturing Yes No Estimated blood loss Pain score Maternal satisfaction score Neonatal outcome- APGAR score in 1 minute APGAR score in 5 minutes Birthweight Newborn special care unit admission- Yes No
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 20/05/2025 Sharing statement has been inserted. PROFORMA Name Age Marital status Occupation Ethnicity Educational status Intervention Time of commencement of intervention How many times intervention was done Time of delivery Mode of delivery Perineal trauma -Yes No If yes First degree Second degree Third degree Fourth degree Suturing Yes No Estimated blood loss Pain score Maternal satisfaction score Neonatal outcome- APGAR score in 1 minute APGAR score in 5 minutes Birthweight Newborn special care unit admission- Yes No I am willing to share my raw data. PROFORMA Name Age Marital status Occupation Ethnicity Educational status Intervention Time of commencement of intervention How many times intervention was done Time of delivery Mode of delivery Perineal trauma -Yes No If yes First degree Second degree Third degree Fourth degree Suturing Yes No Estimated blood loss Pain score Maternal satisfaction score Neonatal outcome- APGAR score in 1 minute APGAR score in 5 minutes Birthweight Newborn special care unit admission- Yes No