Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-03 @ 6:42 AM
Study NCT ID:
NCT05314595
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
The Effect of Bilateral Uterine Artery Ligation as an Added Step for Placental Pouch Closure Technique in Management of Placenta Accreta Spectrum on Reducing Intra-operative Blood Loss: A Comparative Study
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of the study
Primary outcomes:
1. The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
2. Decrease surgical time.
Secondary outcomes:
1. Associated maternal morbidity and mortality.
2. Amount of blood transfusion
3. Difference in hematocrit value before and after delivery
Primary outcomes:
1. The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
2. Decrease surgical time.
Secondary outcomes:
1. Associated maternal morbidity and mortality.
2. Amount of blood transfusion
3. Difference in hematocrit value before and after delivery
Detailed Description:
Introduction Placenta accreta spectrum (PAS) is a term that comprises abnormal placental invasion disorders of the uterine wall. According to the depth of invasion, it ranges from placental invasion in contact with myometrium (placenta accreta), into myometrium (placenta increta), or beyond myometrium (placenta percreta) (Tan, Tay et al. 2007, Cal, Ayres-de-Campos et al. 2018). PAS is an obstetric emergency that may be complicated by emergency hysterectomy, intraoperative surgical complications, massive transfusion, hemorrhagic shock, and even maternal death if not managed efficiently (Ye 2017). Previous cesarean deliveries, placenta previa and advanced maternal age are recognized strong risk factors of PAS, all of which, have become more prevalent among contemporary population (Silver, Landon et al. 2006, Zeng, Yang et al. 2018). Therefore, PAS is no longer a rare disorder in modern practice; the incidence of PAS has increased from approximately 1 in 30,000 deliveries before 1950 to 3 in 1000 deliveries in the current decade (Timor-Tritsch, Monteagudo et al. 2012).
Currently, cesarean hysterectomy is the standard management of PAS (Matsubara, Kuwata et al. 2013). Despite surgical risks, loss of uterine function, and psychological sequences, cesarean hysterectomy permits elective intervention under controlled settings to minimize blood loss (2002). Although several uterus-conserving interventions have been proposed in management of PAS, their contribution to evidence-based practice is limited (Jauniaux, Alfirevic et al. 2018), and cesarean hysterectomy is endorsed as the standard intervention (gynaecology, Gynaecology et al. 2002). Cesarean hysterectomy, without attempting to remove the placenta, may reduce risk of significant bleeding and associated morbidity (Eller, Porter et al. 2009). Leaving the placenta in situ is endorsed as an alternative in patients who refuse hysterectomy being the least invasive uterus-conserving intervention (Jauniaux, Alfirevic et al. 2018, Sentilhes, Kayem et al. 2018).
Nevertheless, the need for evidence-based conservative approaches for PAS cannot be underestimated particularly among women who are highly motivated to preserve their fertility. Despite limited evidence, an international survey indicates that 39% of obstetricians consider conservative management as the primary management. Notably, conservative management was inconsistent among respondents (Cal, Ayres-de-Campos et al. 2018).
Placental pouch closure looks to be an attractive and effective surgical procedure for conservative management of placenta accreta (Zahran, Elsonbaty et al. 2020). In their series of 60 Placenta accreta cases reported that by using this technique,59 out of the 60 enrolled cases, the uterus was successfully conserved and there were no cases of maternal mortality or severe morbidities related to the procedure.
Major blood supply of the uterus comes from the uterine artery, so bilateral uterine artery ligation (UAL) before delivering of the placenta greatly decreasing the blood loss(Lin, Lin et al. 2019). Simultaneously, the ovarian blood flow has not been affected and consequently no changes in ovarian reserve markers occurred, so it is considered one of preserving fertility surgical technique (Verit, Çetin et al. 2019).
Currently, cesarean hysterectomy is the standard management of PAS (Matsubara, Kuwata et al. 2013). Despite surgical risks, loss of uterine function, and psychological sequences, cesarean hysterectomy permits elective intervention under controlled settings to minimize blood loss (2002). Although several uterus-conserving interventions have been proposed in management of PAS, their contribution to evidence-based practice is limited (Jauniaux, Alfirevic et al. 2018), and cesarean hysterectomy is endorsed as the standard intervention (gynaecology, Gynaecology et al. 2002). Cesarean hysterectomy, without attempting to remove the placenta, may reduce risk of significant bleeding and associated morbidity (Eller, Porter et al. 2009). Leaving the placenta in situ is endorsed as an alternative in patients who refuse hysterectomy being the least invasive uterus-conserving intervention (Jauniaux, Alfirevic et al. 2018, Sentilhes, Kayem et al. 2018).
Nevertheless, the need for evidence-based conservative approaches for PAS cannot be underestimated particularly among women who are highly motivated to preserve their fertility. Despite limited evidence, an international survey indicates that 39% of obstetricians consider conservative management as the primary management. Notably, conservative management was inconsistent among respondents (Cal, Ayres-de-Campos et al. 2018).
Placental pouch closure looks to be an attractive and effective surgical procedure for conservative management of placenta accreta (Zahran, Elsonbaty et al. 2020). In their series of 60 Placenta accreta cases reported that by using this technique,59 out of the 60 enrolled cases, the uterus was successfully conserved and there were no cases of maternal mortality or severe morbidities related to the procedure.
Major blood supply of the uterus comes from the uterine artery, so bilateral uterine artery ligation (UAL) before delivering of the placenta greatly decreasing the blood loss(Lin, Lin et al. 2019). Simultaneously, the ovarian blood flow has not been affected and consequently no changes in ovarian reserve markers occurred, so it is considered one of preserving fertility surgical technique (Verit, Çetin et al. 2019).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: