An interventional study of Filled-bladder and non filled-bladder in Placenta Accreta, sponsored by Hatem AbuHashim. Status unknown. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2019-12-24.
Sponsored by Hatem AbuHashim · Not applicable, Interventional, and Prevention
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome.
Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases.
Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.
147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.
This study's planned enrollment of 64 is close to the median of 62 across 63 interventional studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →Hatem AbuHashim is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bladder filling with 300ml diluted methylene blue.
Procedure: Filled-bladder
Procedure: non filled-bladder
Urinary bladder filling with 300 ml diluted methylene blue
Pull up the empty (non-filled) urinary bladder using Allis forceps
Rate of urinary bladder injury
Unintentional bladder injury during elective cesarean hysterectomy
Time frame: Intra-operative (i.e. during surgery).
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Hatem AbuHashim