Placenta AccretaNCT05314595
Bilateral Uterine Artery Ligation in PPC Technique for Management of PAS
A study testing bilateral uterine artery ligation in people with Placenta Accreta, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- bilateral uterine artery ligation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Previous operations
- Gestational age (28 weeks)
- Prenatally suspected PAS based on sonographic and/or MRI findings and/or intrapartum diagnosis of PAS.
- Authorization to participate in the study
Who cannot join
- • Coagulopathies
- Chronic renal or hepatic impairment (baseline first trimester labs are beyond normal range for pregnancy)
- Delivery in an outside hospital (patients referred for ongoing massive bleeding due to PAS)
- Patients coming in emergency condition with bleeding or in labour.
Trial locations and contacts
1 site in 1 country.
About this study
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
Aim of the study
Primary outcomes:
- The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
- Decrease surgical time.
Secondary outcomes:
- Associated maternal morbidity and mortality.
- Amount of blood transfusion
- Difference in hematocrit value before and after delivery
Read the 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).
- Conditions
- Placenta Accreta
- Being tested
- bilateral uterine artery ligation
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral uterine artery ligationProcedure or surgery
- Spinal anaethesia with intrathecal morphia
- Transverse skin incision
- Adequate dissection of the bladder.
- Incision of the uterus above placental edge.
- Delivery of the fetus.
- Delayed cord clamping (60 seconds) if the baby appears well.
- Exteriorization of the uterus.
- Start Oxytocin infusion and uterine massage to ensure good uterine contractions immediately after delivery of the fetus. No trials of placental delivery will be made at this point.
- At this point, a gentile trial to deliver the placenta is performed
- A catheter is placed in the cervix from above to secure the cervical opening
- Compression is applied to the site of bleeding from placenta site
- Placental pouch is marked by multiple allies and is closed down to the multiple-8 suture.
- Blood loss is measured using the suction device and coated socked towels. In modified PPC, Bilateral uterine artery ligation will be done after exteriorization of the uterus in order to minimize the blood loss.
| Study group | Role | What they receive |
|---|---|---|
| modified technique | Experimental | women were underwent modified technique (PPC+ bilateral uterine artery ligation) Receives: Procedure: bilateral uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
bilateral uterine artery ligation
- The effect of bilateral uterine artery ligation and estimation of blood volume loss (VMBL): direct measurement of blood loss in volume units (mL);
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hussein Abouzeid Ahmed, Assiut University
- Investigators
- Kamal M Zahran, Professor, Study chair, Assiut medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314595
- Sponsor's protocol ID
- PAS
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cal M, Ayres-de-Campos D, Jauniaux E. International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2018 Mar;140(3):307-311. doi: 10.1002/ijgo.12391. Epub 2017 Dec 22.
PubMed 29149470Tan CH, Tay KH, Sheah K, Kwek K, Wong K, Tan HK, Tan BS. Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta. AJR Am J Roentgenol. 2007 Nov;189(5):1158-63. doi: 10.2214/AJR.07.2417.
PubMed 17954654Ye M, Yin Z, Xue M, Deng X. High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta. BJOG. 2017 Aug;124(Suppl 3):71-77. doi: 10.1111/1471-0528.14743.
PubMed 28856861Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
PubMed 16738145
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05314595
- Acronym / sponsor ID
- PAS
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study
Primary outcomes:
- The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
- Decrease surgical time.
Secondary outcomes:
- Associated maternal morbidity and mortality.
- Amount of blood transfusion
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified technique | Experimental | Procedure: bilateral uterine artery ligationwomen were underwent modified technique (PPC+ bilateral uterine artery ligation) |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Previous operations
Key exclusion criteria (4 listed)
- • Coagulopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral uterine artery ligation* Spinal anaethesia with intrathecal morphia * Transverse skin incision * Adequate dissection of the bladder. * Incision of the uterus above placental edge. * Delivery of the fetus. * Delayed cord clamping (60 seconds) if the baby appears well. * Exteriorization of the uterus. * Start Oxytocin infusion and uterine massage to ensure good uterine contractions immediately after delivery of the fetus. No trials of placental delivery will be made at this point. * At this point, a gentile trial to deliver the placenta is performed * A catheter is placed in the cervix from above to secure the cervical opening * Compression is applied to the site of bleeding from placenta site * Placental pouch is marked by multiple allies and is closed down to the multiple-8 suture. * Blood loss is measured using the suction device and coated socked towels. In modified PPC, Bilateral uterine artery ligation will be done after exteriorization of the uterus in order to minimize the blood loss. | Procedure or surgery | modified technique |
Primary outcome
bilateral uterine artery ligation
Time frame: 30 months
1. The effect of bilateral uterine artery ligation and estimation of blood volume loss (VMBL): direct measurement of blood loss in volume units (mL);
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 29149470Cal M, Ayres-de-Campos D, Jauniaux E. International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2018 Mar;140(3):307-311. doi: 10.1002/ijgo.12391. Epub 2017 Dec 22.
- Background: PubMed 17954654Tan CH, Tay KH, Sheah K, Kwek K, Wong K, Tan HK, Tan BS. Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta. AJR Am J Roentgenol. 2007 Nov;189(5):1158-63. doi: 10.2214/AJR.07.2417.
- Background: PubMed 28856861Ye M, Yin Z, Xue M, Deng X. High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accreta. BJOG. 2017 Aug;124(Suppl 3):71-77. doi: 10.1111/1471-0528.14743.
- Background: PubMed 16738145Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
- International survey of practices used in the diagnosis and management of placenta accreta spectrum disordersLink provided by the sponsor.
- Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accretaLink provided by the sponsor.
- High-intensity focused ultrasound combined with hysteroscopic resection for the treatment of placenta accretaLink provided by the sponsor.
- Placenta accreta spectrum disorder trends in the context of the universal two-child policy in China and the risk of hysterectomyLink provided by the sponsor.
- Maternal morbidity associated with multiple repeat cesarean deliveriesLink provided by the sponsor.
- Unforeseen consequences of the increasing rate of cesarean deliveries: early placenta accreta and cesarean scar pregnancy. A reviewLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal M Zahran, Professor study chair
Assiut medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral uterine artery ligation in people with Placenta Accreta, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa hussein (01558678842, mostafa.elnazeir1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bilateral uterine artery ligation (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314595, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.