Clinical trial NCT05419804: Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis
Official title: Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis, a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 57
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, planned and elective cs for women diagnosed with accreta, and accepting participation

Brief summary: To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta

Detailed description: Placenta accreta represents a real challenge in modern obstetric care as its incidence is increasing in a parallelism with increased CSs rates. Its management represents another challenge and a multidisciplinary team with clear plans and alternative strategies that fulfill different situation and address different patient needs must be clearly settled in every referral center dealing with placenta accreta.

Hysterectomy without trials of placental separation seems to be the standard and logical procedure. However hysterectomy needs to be a total or at least including the entire invaded Lower uterine segment. Hysterectomy is associated with significant blood loss, and loss of future fertility. There are several fertility conservation approaches with variable success rates, complications, technical demands and costs.

Uterine plication sutures has been reported as successful uterine conservation strategy but subsequent intrauterine adhesions, weak uterine scar and uterine necrosis might culminate in a functionless uterus.

The present work describes total lower uterine segmentectomy with cervical-corporeal anastomosis as a relatively less invasive uterine conservation strategy with minimization of blood loss and transfusion needs. Furthermore, total lower uterine segmentectomy with cervico-corporeal anastomosis has the merits of leaving behind a strong scar and a well-functioning uterus.

Eligibility criteria: Inclusion Criteria:

pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, Planned and elective cs for women diagnosed with accreta, and accepting participation

Exclusion Criteria:

women who don't accept participation, women who desire hysterectomy. Women who diagnosed with accrete and placenta separated easily women with concomitant pathology and requiring hysterectomy .

Primary outcomes:
measure: Success of procedure
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Medical School
Study officials:
affiliation: Assiut medical school
name: Ezzat H Sayed, professor
role: STUDY_CHAIR
References:
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citation: Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.
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citation: Abo-Elroose AA, Ahmed MR, Shaaban MM, Ghoneim HM, Mohamed TY. Triple P with T-shaped lower segment suture; an effective novel alternative to hysterectomy in morbidly adherent anterior placenta previa. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3187-3191. doi: 10.1080/14767058.2019.1678145. Epub 2019 Oct 15.
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