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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207835155214 Date of Approval: 21/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perineal Massage During The Second Stage Of Labour For Preventing Perineal Trauma In Nulliparous Women: A Randomised Controlled Study.
Official scientific title Perineal Massage During The Second Stage Of Labour For Preventing Perineal Trauma In Nulliparous Women: A Randomised Controlled Study.
Brief summary describing the background and objectives of the trial Perineal trauma is common during childbirth especially in the nulliparous women. Perineal trauma include any spontaneous or iatrogenic (including episiotomy) injury to the perineum. Perineal massage increases elasticity and blood supply to the perineum and leads to easier stretching of the muscles and less pain during childbirth. However, the use of perineal massage in preventing perineal injury has yielded varied results. Further research into the effect of perineal massage on the reproductive system during labour is therefore needed. AIM: This study will determine the effectiveness of perineal massage during the second stage of labour in preventing perineal trauma in nulliparous women. OBJECTIVES: To determine the effect of perineal massage during the second stage of labour on the rate of episiotomy and other perineal tears, the duration of second stage, neonatal outcome (Apgar scores) and the severity of perineal pain at 4 hours and 24 hours postpartum.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied perineal trauma
Purpose of the trial Prevention
Anticipated trial start date 16/06/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 16/12/2022
Actual Last follow-up date 31/01/2023
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard of care standard of care given timely standard of care during the second stage of labour. standard of care. All the patient in that arm will receive standard of care during the second stage of labour 52 Historical
Experimental Group Lubricated perineal massage 10 minutes in the second stage of labour After wearing sterile gloves and lubricating the index and middle fingers with 5mls sterile lubricant (a colourless, odourless, and water-soluble substance called K – Y Jelly), the resident doctor (senior registrar) to conduct the delivery will massage the perineum with a gentle up-down pressure towards the rectum in a way that each movement lasts one minute along 3 o'clock and 9 o'clock positions (U-shaped reciprocating motion) in the second stage of labour. Overall, each participant in the intervention group will be massaged for 10 minutes, and the degree of downward pressure will be determined by the participants' responses, with the pressure being eased if they express pain or burning sensation. 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Nulliparous women in the age bracket of 18 to 35years 2. Gestational age 37-42weeks 3. Singleton fetus 4. Cephalic presentation 5. Cervical Os dilatation of 10 cm 1. Poor progress of labour 2. Fetal distress 3. Instrumental vaginal delivery 4. Erythematous rashes and oedema of the perineum 5. Female genital mutilation 6. Voluntary withdrawal 7. Need for Caesarean section 8. Prematurity 9. Malposition 10.Ultrasound estimated birth weight more than 4.0kg and less than 2.5kg Adult: 19 Year-44 Year 18 Year(s) 35 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 06/06/2022 Nnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Onitsha Road, Nnewi Nnewi 420001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants having perineal tears during vaginal delivery between the intervention and control groups immediately after vaginal delivery
Secondary Outcome Proportion of participants having episiotomy during vaginal delivery between the intervention and control groups immediately after vaginal delivery
Secondary Outcome Duration of second stage of labour between the two groups after second stage of labour
Secondary Outcome Perineal pain and its severity between the intervention and control groups 4 and 24 hours after vaginal delivery respectively
Secondary Outcome Neonatal birth weights, 1st and 5th minute Apgar scores between the intervention and control groups 1st and 5th minutes after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Onitsha Road Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nnabuchi Obinna kenneth obiofia-Nnewichi nnewi 420001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Obinna Kenneth Nnabuchi Nnewi Onitsha road Nnewi Anambra State Nigeria Nnewi 435101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr George Uchenna Eleje Nnewi Anambra 420001 Nigeria
Prof. Joseph Ifeanyi Brian D Adinma Nneni Anambra 420001 Nigeria
Professor Joe Ikechebelu Awka Anambra 420001 Nigeria
Dr Chigozie Geoffrey Okafor Nnewi Anambra 435101 Nigeria
Dr Golibe Christian Ikpeze Nnewi Anambra 435101 Nigeria
Dr Nnaedozie Paul Obiegbu Nnewi Anambra 433101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Obinna Nnabuchi drnnabuchi2@gmail.com +2347039540731 Nnewi
City Postal code Country Position/Affiliation
Anambra State 435101 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries George Uchenna Eleje gu.eleje@unizik.edu.ng +2348068117444 Nnewi
City Postal code Country Position/Affiliation
Anambra State Nigeria Head Of Department
Role Name Email Phone Street address
Public Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Nnewi Onitsha road Nnewi Anambra State Nigeria
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Immediately following publication, No end date Beginning 3 months and ending 5 years f Not applicable
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