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.: PACTR201510001314191 Date of Approval: 21/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The cervix as a natural tamponade in postpartum hemorrhage caused by placenta previa and placenta previa accreta: a prospective study
Official scientific title The cervix as a natural tamponade in postpartum hemorrhage caused by placenta previa and placenta previa accreta: a prospective study
Brief summary describing the background and objectives of the trial Background: Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with placenta accreta may reach as high as 7-10%. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze, balloon tamponades, the B-Lynch suture, insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries, but there is a wide variation in the success rate of these maneuvers. In a case report, Dawlatly et al. (2007) described a simple technique of suturing an inverted lip of the cervix over the bleeding placental bed that was successful in controlling the bleeding, saving the patient¿s life, and preserving her uterus. The objectives of this trial is to evaluate the safety and efficacy of the use of this Dawlatly stitch as a natural tamponade for controlling postpartum haemorrhage in cases of placenta previa and/ or placenta previa accreta.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Placenta previa, placenta accreta,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2012
Actual trial start date 01/06/2012
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 208
Actual target sample size (number of participants)
Recruitment status 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
Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cervical inversion as a natural tamponade using Dawlatly stitich Once during cesarean section Surgical technique Significant bleeding from the placental bed during placenta previa/placenta accreta cesarean section was managed by inverting the cervix into the uterine cavity and suturing the anterior and/or the posterior cervical lips into the anterior and/or posterior walls of the lower uterine segment.With this technique, the cervix can be used as a natural tamponade replacing the artificial tamponades. 100
Control Group Standard managment of PPH as per hospital protocol Oxytocin 20-40 IU/L IV fluid infusion- Syntometrine (5 IU Oxytocin + 0.5mg ergometrine- 100MG carbetocin -Bakri Balloon insertion-operative intervention 1- Medical management: Oxytocin 20-40 IU/L IV fluid infusion- Syntometrine (5 IU Oxytocin + 0.5mg ergometrine- 100MG carbetocin 108 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-All participating women had one or more previous cesarean deliveries. 2-were diagnosed with placenta previa and/ or placenta previa accreta by ultrasound. When the ultrasound result was not conclusive for placenta accreta, MRI was performed. 3-All participating women desired to preserve their fertility 4-Patients with focal (partial) placenta previa accreta/ placenta previa. 1-placenta percreta. 2-diffuse placenta accreta or increta. 3-uncontrollable postpartum hemorrhage. 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 17/03/2012 The Department ethical committee-Minia university Hospital
Ethics Committee Address
Street address City Postal code Country
Department of Obstetrics And Gynaecolgy- Faculty of Medicine-Minia University Minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Successful control of bleeding 1- Intra-operative 2- Post-operative
Primary Outcome Need for hysterectomy 1- Intra-operative 2- Post-operative
Primary Outcome Incidence of complications 1-short term 2-long term
Secondary Outcome The mean blood loss 1-Intra-operative 2-Post-operative
Secondary Outcome The mean number of blood units transfused 1-Intra-operative 2-Post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia Maternity & Children University Hospital Faculty of Medicine, Minia University Minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia Maternity and Children University Hospital Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Saad A ElGelany Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt
Mo'men M Hassan Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt
Mohammed T Gad ElRab Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt
Ayman M Youssef Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt
Emad M Ibrahim Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt
Eissa M khalifa Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelraheim arabdelraheim@yahoo.com +201096860338 Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University
City Postal code Country Position/Affiliation
Minia 61111 Egypt Lecturer Of Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Saad ElGelany saad.elgelany@yahoo.co.uk +201068700595 Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University
City Postal code Country Position/Affiliation
Minia 61111 Egypt Assistant Professor of obstetrics And Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Mo'men Hassan memoharty@yahoo.com +201005766439 Department Of Obstetrics and Gynaecology- Faculty Of Medicine-Minia University
City Postal code Country Position/Affiliation
Minia 61111 Egypt Lecturer Of Obstetrics and Gynaecology
REPORTING
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