Effectivness of Conservative Techniques in Management of PAS

Placenta Accreta Clinical Trial

Official title:

Effectivness of Conservative Techniques in Management of PAS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05104177
• Other study ID #: conservative techniques in PAS
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: mohammed heshmat
• Phone: 01030752354
• Email: heshmatm905[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity

Description:

Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium . 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 . PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality . 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 . The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture . Recently, Women's health hospital has adopted a new approach for conservative management of most cases of PAS, including wedge resection of the myometrium over the adherent part of the placenta, or a staged-approach following delivery of the fetus starting with meticulous dissection of the urinary bladder form the lower uterine segment, then bilateral uterine artery ligation at a level below the apparent placenta-myometrial bulge, followed by removal of the placenta, after which a catheter is inserted in the cervix and the placental pouch is closed .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

1. - Gestational age starting from 28 weeks onwards.

2. - Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)

3. - Elective or emergent Caesarean deliveries

Exclusion Criteria:

• A pre-existing decision of performing intrapartum hysterectomy

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Procedure:
• conservative tecchniques in management of PAS
Meticulous complete dissection of the urinary bladder from the lower uterine segment. Transverse uterine incision above the visible vascular bulge if visible in cases with anterior PAS, otherwise a transverse lower uterine segment incision is performed in the same site of previous CS scar. Delivery of the baby, clamping of the cord and administration IV 10 IU oxytocin. Bilateral uterine artery ligation at one or two levels below the lowermost part of the placenta. Removal of the separable part of the placenta from above downwards, until the adherent part is encountered. A decision is taken to either resect a wedge of the myometrium above the adherent placenta (in case the adherent area is small and anterior), or removing all the adherent placenta then inserting a rubber or plastic catheter inside the cervical canal then identifying and closing the placental pouch. Care is given to rapidly perform this step to decrease the blood loss after removing the placenta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who undergo hysterectomy after failure of conservative techniques	Counting patients who undergo hystrectomy after conservative techniques to evalute it's effectivness	baseline
Secondary	recurrence of PAS	Nomber of cases recurrence who will have of PAS In subsequent pregnancies after conservative techniques	baseine