An interventional study of Tamponade of lower uterine segment in management of placenta accreta spectrum cases and partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases in Placenta Accreta, sponsored by Assiut University. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .
Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium (1-2). Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS (3). PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality (4).
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches (5).
The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture (1). Several techniques have been described for controlling massive bleeding associated with placenta previa caesarean 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 awide variation in the success rate of these maneuvers. Over-sewing of the bleeding site is the most common procedure used for PPH management, but in many cases, the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding(
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 222 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1-Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .
2 - Gestational age starting from 28 weeks onwards. 3- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy) 4- Elective or emergent Caesarean deliveries
Exclusion Criteria:
usage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases
Procedure: Tamponade of lower uterine segment in management of placenta accreta spectrum cases
partial resection of lower uterine segment myometrium
Procedure: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum
tamponade vs partial myomertial resection of lower uterine segment in managment of placenta accreta spectrum cases
amount of intraopertive blood loss.
compare of amount of blood loss between two methods by adding collected blood in suction apparatus in milliliters to amount of biood in the soaked towels
Time frame: 2 years
ICU admission
yes or no admission number of days if there is ICU admission cause of admission
Time frame: 2 years
Re exploration
if there is exploration or no cause of re-exploration outcome of re-exploration
Time frame: 2 years
drop of HB level postoperative
result of substitution of HB level postoperative from preoperative in gmldl
Time frame: 2 years
blood transfusion
amount of transfused blood units
Time frame: 2 years
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Sep 2024; primary completion for Aug 2026, 23 months later.
Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 23 months is above that.
Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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