An interventional study of A glove-loaded Foley's catheter tamponade and stepwise uterine devascularization in Placenta Previa and Post Partum Hemorrhage, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Aswan University Hospital · Not applicable, Interventional, and Prevention
Objective: To investigate the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.
Postpartum hemorrhage (PPH) due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation.
Despite placenta previa can be diagnosed by obstetrician before delivery nowadays, still a leading etiology of maternal mortality and morbidity.
Placenta previa is an obstetric condition that is closely linked with massive obstetric hemorrhage. Is not only associated with increased chance of requiring massive transfusion (> 3 units of packed red blood cells) but also a is now the leading etiology of the cesarean hysterectomies. The incidence has progressively risen worldwide, mainly due to the increasing rates of cesarean section.
Uterine tamponade can be considered as a line of treatment before performing surgical procedures in PPH resulting from the placental site bleeding. It can save the life, avoid laparotomy and preserve fertility.
Nowadays, the use of intrauterine balloons has been developed and become effective for the control of placental site bleeding not responding to medical treatment.
The 2-way Foley's catheter has many advantages over the gauze packing; first, it allows drainage of blood, so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's catheter balloon is easy and not painful, third, the removal of 2-way Foley's catheter could be gradual as a test of its effectiveness before complete removal.
Bakri intrauterine balloon tamponade is used for the treatment of obstetric hemorrhage during cesarean delivery and many recent reports had described the successful use of balloon tamponade to manage hemorrhage due to placenta previa- with an overall success rate of 80%. However; its price is high so in our country, its availability and use are difficult.
So, the aims of this study to assess the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.
The study will be single blinded randomized controlled trial carried out in a tertiary University Hospital between June 2018to June 2021. The included patients will be scheduled for CS due to complete placenta previa. They will be randomly allocated to the group (I) managed by stepwise uterine devascularization, group (II) managed by A glove-loaded Foley's catheter tamponade. The primary outcome will be the amount of intraoperative estimated blood loss.
80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.
This study's enrollment of 120 is above the median of 109 across 45 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Patients with the cardiac, hepatic, renal, or thromboembolic disease;
Uterine hemostatic sutures, through examination of the placental bed, may use some hemostasis at the placental bed,"overswing" was commenced using endo-uterine sutures. If there is still significant bleeding, bilateral uterine artery ligation, and internal iliac artery ligation when needed.BUAL started immediately through blunt dissection downwards and laterally of the peritoneum covering the uterine isthmus and cervix. The peritoneum is mobilized freely at the uterine angles to expose both uterine arteries and avoid inclusion of the ureters in the ligation. The uterine artery pulsations were palpated digitally at the level of the internal os.
Procedure: stepwise uterine devascularization
A glove-loaded Foley's catheter tamponade, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 300 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures. Only one glove-loaded Foley's catheter was used for tamponade.
Procedure: A glove-loaded Foley's catheter tamponade
A glove-loaded Foley's catheter tamponade, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 300 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures. Only one glove-loaded Foley's catheter was used for tamponade.
Also known as: Foley's tamponade
Uterine hemostatic sutures, through examination of the placental bed, may use some hemostasis at the placental bed,"overswing" was commenced using endo-uterine sutures. If there is still significant bleeding, bilateral uterine artery ligation, and internal iliac artery ligation when needed.BUAL started immediately through blunt dissection downwards and laterally of the peritoneum covering the uterine isthmus and cervix. The peritoneum is mobilized freely at the uterine angles to expose both uterine arteries and avoid inclusion of the ureters in the ligation. The uterine artery pulsations were palpated digitally at the level of the internal os.
intraoperative blood loss
blood loss during operation
Time frame: during the operation
cesarean hysterectomy
cesarean hysterectomy
Time frame: intraoperative
need for blood transfusion
need for blood transfusion
Time frame: intraoperative and post operative 4 hours blood loss estimation
postoperative blood loss
blood loss post operative
Time frame: 4 hours post operative
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Aswan University Hospital