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.: PACTR202209687644401 Date of Approval: 02/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of 2hrs versus 6hrs oral feeding on recovery of normal bowel functions after Caesarean Section performed under regional anesthesia
Official scientific title Effect of 2hrs versus 6hrs oral feeding on recovery of normal bowel functions after Caesarean Section performed under regional anesthesia A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Aim of the study was to compare effect of early postoperative oral feeding versus late oral feeding on return of bowel movements in patients had cesarean section under regional anesthesia. after elective cs under regional anesthesia pt divided into 2 groups Group I (intervention group " early 2hrs oral hydration") These women were given a cup of 200ml of water after about 2 hours of surgery. they were allowed to chew gum and drink whatever they wanted after that according to their needs then started semisolid food at bowel movement. . Group II (control group "6hrs oral hydration") these women were allowed to drink after 6 hours. they were allowed to drink and chew gum whatever they wanted after that according to their needs then started semisolid food at bowel movement. Intravenous fluids regimen was the same for 2 groups analgesia was the same... While the woman was in the recovery room and after transferring her to the postpartum ward, the following data were collected after excluding postpartum hemorrhage 1-Return of intestinal movements 2-Passage of flatus 3-The occurrence of vomiting and abdominal distention 4-The occurrence of nausea and abdominal pain 5-Time of Initiation of breastfeeding. and Duration of hospital stay:
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 Physical activity and nutrition
Anticipated trial start date 14/12/2020
Actual trial start date 02/01/2021
Anticipated date of last follow up 01/05/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 186
Actual target sample size (number of participants) 140
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral feeding 200ml of water after about 2 hours of surgery according to her needs then started semisolid food at bowel movement. the woman was given a cup of 200ml of water after about 2 hours of surgery. She was allowed to chew gum and drink whatever she wanted after that according to her needs then started semisolid food at bowel movement. Intravenous fluids regimen: All women were given the same hospital intravenous fluid regimen which was 500 ml of 5% glucose every 8 hours, 500 ml of Ringer lactate every 6 hours and 500 ml of normal saline every 12 hours. Taking into consideration that these intravenous fluids were discontinued when the bowel movements started early and the woman feeding was well established before 24 hours. All women received the same routine analgesia that was added to the first bottle of intravenous fluids given to them in the recovery room; it was Epicotil 20mg IV injection/12 hours. 70
Control Group oral feeding the woman was allowed to drink after 6 hours he was allowed to drink and chew gum whatever she wanted after that according to her needs then started semisolid food at bowel movement. the woman was allowed to drink after 6 hours. She was allowed to drink and chew gum whatever she wanted after that according to her needs then started semisolid food at bowel movement. the fluid regimen and analgesia was the same as prescribed in experimental group 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Term Singleton Pregnancy. 2-Uncomplicated Elective Caesarean Section. 3-No intra or postpartum hemorrhage. 4-All caesarean sections performed under spinal anesthesia. 1-BMI > 30 kg/m2. 2-Multiple pregnancy and polyhydramnios. 3-Medical disorders such as Diabetes, Hypertension and anemia 4-Surgical Complications Such as intestinal or bladder injury. 5-Postpartum Hemorrhage. Adult: 19 Year-44 Year 18 Year(s) 40 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 13/12/2020 Ain Shams University Faculty OF medicine Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
elabassia cairo none Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The assessment of the return of bowel functions after C-section, as gauged by time to 1st flatus. women were asked about passage of flatus every hour postoperatively
Secondary Outcome 1- detection of intestinal sounds 2-The evaluation of GI complications, 1-mild ileus symptoms and severe ileus symptoms. The presence of anorexia, abdominal cramping, or mild distension on physical examination is defined as mild ileus symptoms. Marked abdominal distension with more than 3 episodes of vomiting in 24 hrs after surgery, or the inability to tolerate a liquid diet with delayed step diet is defined as severe ileus symptoms. Abdominal auscultation was done 2 hours postoperatively and every 1 hour to detect intestinal sounds. The occurrence of vomiting and abdominal distention were taken from women every 1 hour in the 1st
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Maternity Hospital elabassia cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University elabassia cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University elabbasia cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ain Shams University elabassia cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Sayed Snosi drmarwasnosi@gmail.com +201200522228 hadeq el qubba
City Postal code Country Position/Affiliation
cairo Egypt lecturer of obstetrics and gynecology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Lamiaa Ismail lamiaashahin4@gmail.com +201000519320 tokh
City Postal code Country Position/Affiliation
banha Egypt resident of obstetrics and gynecology tokh central hospital
Role Name Email Phone Street address
Scientific Enquiries Marwa Sayed snosi drmarwasnosi@gmail.com +021200522228 hadeq el qubaa
City Postal code Country Position/Affiliation
cairo Egypt lecturer of obstetrics and gynecology Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data cannot be shared due to privacy issues Study Protocol Data cannot be shared due to privacy issues Availability upon request due to privacy issues
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/08/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/08/2022 Result - 30/08/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information