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.: PACTR202312583411798 Date of Approval: 13/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of single versus double layer uterine closure during caesarean section on niche formation and menstrual irregularity
Official scientific title Effect of single versus double layer uterine closure during caesarean section on niche formation and menstrual irregularity: A randomized controlled trial
Brief summary describing the background and objectives of the trial Double-layer compared to single-layer closure of the uterus during a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. We aimed to conduct a randomized controlled trial to determine the superiority of double-layer unlocked uterine closure on postmenstrual spotting and niche formation after a first CS, compared with single-layer unlocked uterine closure.
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 Treatment: Surgery
Anticipated trial start date 25/10/2022
Actual trial start date 02/11/2022
Anticipated date of last follow up 02/06/2023
Actual Last follow-up date 10/06/2023
Anticipated target sample size (number of participants) 297
Actual target sample size (number of participants) 240
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
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Double layer continuous uterotomy suture Six months follow-up Double-layer closure of the uterine incision was performed using unlocked continuous sutures for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricated the first layer, including serosal and myometrial tissue. 120
Control Group Single layer continuous uterotomy suture Six months follow-up Single layer group received uterine closure with unlocking. Uterine closure was done from one corner of the incision and then the uterine incision wound was closed using Polyglactin thread ( 1-0) include endometrium, myometrium and serosa. 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Primigravida women undergoing elective cesarean section, 2) Singleton term pregnancies after 37 gestational weeks, 3) Age: 18 – 40 years, 4) Non lactating and non-hormonal contraception. a) Previous uterine surgery (myomectomy or metroplasty), b) Women with known causes of menstrual disorders (abnormal Uterine Bleeding in the form of premenstrual or postmenstrual spotting, dysmenorrhea, and amenorrhea), c) Placenta accreta spectrum during the current pregnancy, d) Cases associated with poor wound healing as steroid administration or patients with antenatal anemia, e) Medical conditions as diabetes mellitus, f) Risk of endometritis and puerperal sepsis g) 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 25/10/2022 Research Ethics Committee of Ain Shams University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Abbasia, Cairo, Egypt. Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-menstrual spotting over 3 successive spontaneous menstrual cycles. Six months post-intervention.
Secondary Outcome Ultrasound findings suggestive of niche formation Six months post-intervention.
Secondary Outcome Dysmennorhea, dyspareunia, and premenstrual spotting. Six months post-intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams Maternity Hospital Ramsis street - Ain Shams Maternity Hospital Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams Maternity Hospital Ramsis street - Ains Shams Maternity Hospital Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Mohamed 25 El Haram Street - Giza - Cairo Giza 12556 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohamed 25 El Haram street - Giza - Egypt Giza 12556 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Ahmed Mohamed ma0974846@gmail.com +201151366151 25 El Haram Street - Giza Egypt
City Postal code Country Position/Affiliation
Giza 12556 Egypt Assistant professor Obstetrics and Gynecology
Role Name Email Phone Street address
Principal Investigator Esraa Hussein Fouad Ghoneimy esraaghoneimy81@gmail.com +201008057054 158 Abbasiya street - Cairo -Egypt
City Postal code Country Position/Affiliation
Cairo 11517 Egypt Lecturer Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Walid Hitler mohamedkhaled858585@gmail.com +201111410041 59 El Dokki street - Giza - Egypt
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant professor Obstetrics and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Not decided to share Study Protocol Not decided to share Available upon request only.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No 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