A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAin Shams University

About this trial

The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018).

caesarean hysterectomy is considered the gold standard for the treatment of placenta accreta. Also this radical approach is associated with high rates of severe maternal morbidity as hemorrhage and insult to surrounding organs during surgery (Hoffman et al., 2010).

Surgeons should be able to dissect the bladder safely and confidently through minimally invasive techniques, to avoid surgical injury, it is important to use anatomic landmarks, minimize the use of cauterization (Farhat and Casale, 2018).

All centers are encouraged to develop guidelines to manage the potential urologic complications of these cases tailored to their resources (Taneja and Shah, 2017).

This study aims to evaluate the timing of bladder dissection in caesarean section in patient with placenta accreta spectrum.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women with BMI at or under 35kg/m2

Women with history of at least previous two caesarean section

Gestational age more than 32 weeks with viable fetus.

Women with any degree of placenta previa.

Disqualifiers

o History of urinary bladder injury.

History of urinary or renal disorders

Women with coagulation disorders or on anticoagulation therapy.

Patients who are hemodynamically unstable before skin incision

Trial design

Design model

Parallel

Treatments tested in this trial

  • bladder dissection in placenta accreta spectrum

    Procedure/Surgery

    All caesarean sections will be performed by a surgeon who has experience in performing caesarean hysterectomy in both groups. * Scrubbing the abdomen as usual. * Subumblical midline skin incision versus Pfannenstiel incision will be chosen according to site of the placenta and previous surgeries. * In group A careful bladder dissection will be done before uterine incision with ensuring hemostasis, uterine incision will be done above the placenta, after delivering the baby awaiting for placental separation if not proceeding for caesarean hysterectomy. * In group B uterine incision will be done above the placenta and after delivering the baby awaiting for placental separation if not proceeding to caesarean hysterectomy and dissecting bladder just before clamping uterine artery.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: group AActive comparator 1 intervention
Group B: group bActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

o Blood loss

assessed by number of soaked towels and suction reservoir)

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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