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.: PACTR202309863209397 Date of Approval: 13/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of normal saline ice packs on blood loss after delivery: A randomized clinical trial.
Official scientific title Effect of normal saline ice packs on blood loss after delivery: A randomized clinical trial.
Brief summary describing the background and objectives of the trial Obstetric hemorrhage is the commonest single cause of maternal mortality worldwide. Without timely and appropriate treatment, postpartum hemorrhage (PPH) may ensue and lead to disseminated intravascular coagulation, hemorrhagic shock, multiple organ failure, and even death. Hemorrhage is very common in both urgent and elective cesarean sections (CS) and often requires B-lynch suture, uterine artery ligation, transcatheter arterial embolization, and even hysterectomy to stop bleeding. However, these approaches are rather difficult to carry out, especially in resource-poor settings. Another choice is intrauterine packing, which stops bleeding to some extent using compression power and is used effectively in resource poor settings. However, this technique may affect the suture of the uterine incision and cause infection. Iced saline solution has been used to treat gastric lavage in gastroduodenal hemorrhage caused by peptic ulcer and erosive gastritis and has been shown to be effective for control of active hemorrhage. The constant cold stimulation on the myometrium causes muscles to shrink, introducing the homeostasis effect. Also, a cold compress can cause local blood flow to decrease, during the process of which coagulation is facilitated as local blood flow slows down, blood thickens and platelets aggregate. This raised the assumption that application of ice packs on the uterus after delivery would be associated with decreased blood loss. Primary objective: To evaluate the amount of blood loss between women who applied ice packs and those who did not. Secondary objective: To determine the prevalence of PPH among both groups.
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 Prevention
Anticipated trial start date 10/09/2023
Actual trial start date 15/09/2023
Anticipated date of last follow up 10/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
Recruitment status Active, not 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
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
Control Group control group routine management of labor 30 min after delivery active management of labor 23 Active-Treatment of Control Group
Experimental Group ice packs group ice packs immediately after delivery for 30 minutes. 30 min ice packs immediately after delivery for 30 minutes. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged between 18-45 years, any parity. women having vaginal delivery. full term singleton pregnancy women with medical disorders such as diabetes, hypertension, sickle cell disease, or bleeding disorders, severe anemia defined as hemoglobin level ≤ 7gm/dl (9), abnormal placentation as placenta previa- accreta spectrum, placental abruption, pregnancy-related complications as severe preeclampsia, women on anticoagulant therapy, women refusing to participate in the study. Adult: 19 Year-44 Year 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 20/06/2023 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road, kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the amount of perioperative blood loss 24 hours after delivery
Secondary Outcome the change in hemoglobin level 24 hours after delivery, the need for additional uterotonics, and the incidence of PPH 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road, kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
omima tharwat ring road, kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal universityq ring road, kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
omima tharwat ring road, kilo 4.5 ismailia Egypt
hanaa helmi ring road, kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hanaa helmi Hanaa.helmi@yahoo.com 01223423685 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt Lecturer of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant professor of obstetrics and gynecology
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant professor of obstetrics and gynecology
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 after completion of the study after approval of the research ethics committee
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