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.: PACTR202101553712948 Date of Approval: 28/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Extra virgin olive oil effect on nipples
Official scientific title Effect of Application of Extra Virgin Olive Oil (Evoo) versus expressed breast milk (EBM) on painful and damaged nipples during lactation
Brief summary describing the background and objectives of the trial Nipple damage, which includes pain or cracks, and soreness are common problems that frequently occur after breastfeeding. When the nipples are injured, breastfeeding is put in danger. It is estimated that 34%–96% of breastfeeding women experience nipple soreness that may resort to premature weaning. Moreover, up to one-third of mothers who experience these problems may change to other methods of infant nutrition within the first 6 weeks postnatal. Extra virgin olive oil (EVOO) has immunological, anti-inflammatory, antioxidant, antibacterial, and antifungal properties. It has been used by researchers for the prevention and treatment of nipple trauma since it is an easily attainable and relatively inexpensive substance. Moreover, it had been used for sore nipples in Mediterranean countries for years. Breast milk (BM) is also used for preventing and treating nipple trauma, due to its healing elements, such as growth factors, anti-inflammatory, and anti-microbial substances. These protective factors help explain the effects of breast milk in healing nipple trauma in breastfeeding women. Thus, we aimed to evaluate the effectiveness of the application of EVOO versus BM on nipple trauma and pain among lactating women. The aim of this work is to evaluate the effect of extra virgin olive oil compared to breast milk on painful and damaged nipples during lactation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied Breast feeding
Purpose of the trial Treatment: Other
Anticipated trial start date 25/09/2019
Actual trial start date 25/09/2019
Anticipated date of last follow up 25/12/2019
Actual Last follow-up date 25/12/2019
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Extra virgin olive oil EVOO a few drops of EVOO after each baby feeding, day and night prepared natural EVOO using the cold press method, which had 0.8% acidity and no more than 0.8 grams of oleic acid per 100 grams of oil, and subsequently stored it in the dark at room temperature until use. The women in group 1 (intervention group) applied a few drops of EVOO to their nipples after breastfeeding, 60
Control Group Breast milk a few drops of breast milk after each baby feeding, day and night Women applied a few drops of breast milk to their nipples after breastfeeding 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women who are willing to participate, have normal nipple skin, have breastfed their baby during the first 12 hours after birth, have not used any ointment, oil, or any medication to the nipples Women who have any medical contraindication for breastfeeding were diagnosed by ultrasound to deliver a baby with cleft lip or palate or other congenital anomalies that interfere with normal suckling have any psychological or mental disorder, allergic to EVOO. Adult: 19 Year-44 Year 21 Year(s) 39 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 18/09/2019 Ethical committee for scientific research review menoufia university faculty of nursing
Ethics Committee Address
Street address City Postal code Country
Gamal Abdelnaser street Kebly Sheben Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain - subject's level of pain intensity during breastfeeding the 3rd, 7th, and 14th days of postpartum period
Primary Outcome Nipple trauma - Occurrence/healing the 3rd, 7th, and 14th days of postpartum period
Secondary Outcome Areolar skin reaction the 3rd, 7th, and 14th days of postpartum period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maternal and child health center Gamal Abdelnaser street Kebly Menufia governorate Sheben Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Naglaa Ahmed 9 Mamdouh Nassar Quessna Menoufia 32631 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faulty of nursing Menoufia university Yassin Abdelghafar street Sheben Elkom Menoufia governorate 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nadia Bassuoni Elsharkawy 19 Elhoria Street Cairo 11765 Egypt
Amina Ibrahim Badawy Othman EL Nahda street Quessna 32631 Egypt
Amal Ahmed Kanona Habib Street Qotor 31726 Egypt
Samah M. Abd Elgaphar Alashgar street Cairo 11765 Egypt
Amal Gamal Almaady Street Cairo 11728 Egypt
Hemat Mostafa Amer Elmeslha street Sheben ElKom 32513 Egypt
Nagat Salah Shalaby Elmaadia street Port said 42513 Egypt
Fatma Elemam Hafez Elemam Elgash Street Port said 42513 Egypt
Naglaa Abdelmawgoud Ahmed Mamdouh Nassar Quessna 32631 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amina Othman amina73737373@yahoo.com 00201033202175 EL Nahda street
City Postal code Country Position/Affiliation
Quessna Menoufia 32631 Egypt Assistant professor Medical Surgical Nursing Faculty of nursing Menoufia University Egypt
Role Name Email Phone Street address
Scientific Enquiries Naglaa Ahmed naglaa.abdalmaougod13@nursing.menofia.edu.eg 00201002163918 9 Mamdouh Nassar
City Postal code Country Position/Affiliation
Quessna Menoufia 32631 Egypt Assistant professor Family and Community Health Nursing Faculty of Nursing Menoufia University Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A Yes 26/01/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/01/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information