Clinical trial NCT06712576: Evaluation of Planned Conservative Surgical Management of Placenta Accreta Spectrum in Women's Health Center, Assiut University Hospital
Official title: Evaluation of Planned Conservative Surgical Management of Placenta Accreta Spectrum in Women's Health Center, Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Placenta Accreta
Keywords: planned conservative surgical managemen
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with placenta accrete spectrum secondary to previous cesarean section and Gestational age above 28 weeks

Brief summary: In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. the aim of the study To evaluate conservative surgical management of placenta accreta spectrum in Assiut University hospital regarding maternal and fetal outcomes.

Detailed description: Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.

Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.

Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women with history of previous caesarean section.
2. Age above 18 years.
3. Gestational age above 28 weeks.
4. U/S signs suggestive of placenta previa accreta.
5. Confirmed diagnosis of Placenta previa accreta spectrum disorder by 3 D U/S, Doppler or MRI if needed.

Exclusion Criteria:

1. Gestational age less 28 weeks.
2. Age less than 18 years.
3. Patients with known bleeding disorders.
4. Multiple pregnancy.
5. Other pathology (fibroid, ....................).
6. Patients with placental separation.

Primary outcomes:
measure: amount of blood loss
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cali G, Forlani F, Giambanco L, Amico ML, Vallone M, Puccio G, Alio L. Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:36-41. doi: 10.1016/j.ejogrb.2014.05.007. Epub 2014 May 21.