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NCT Number: NCT06861972

Caesarean Hysterectomy Versus Conservative Management of Placenta Accreta: A Comparative Study

Placenta accreta rates are rising alongside the rising rates of caesarean deliveries. This has lead to a vast number of studies negotiating the histopathological nature, risk factors and outcomes of pregnancies complicated with placenta accreta. In the study the investigators re discussing the outcome of different plans of management of placenta accreta, namely caesarean hysterectomy and focal myometrium resection.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

Rising rates of caesarean delivery worldwide and especially in Egypt have affected higher rates of placenta accreta spectrum disorders. The increasing prevalence of this life-threatening condition can be primarily prevented by efforts targeted at reducing primary caesarean deliveries as well as encouraging trial of labor after caesarean deliveries of carefully selected gravidas in well-equipped hospitals, capable of providing continuous electronic fetal heart rate monitoring, along with offering one to one health care based systems with the capability of performing emergency caesarean deliveries when needed. As for secondary prevention, the best surgical approach to uterine incisions in caesarean deliveries is yet to be found and universally applied. The said approach will aim at decreasing short and long term complications of uterine scarification resulting in decreased number of placenta accreta cases and possibly downgrading their difficulty, too. Having failed to prevent such occurrence, optimization of PAS management can be attempted to try and decrease implicated injuries. As previously noted, multidisciplinary systematic approach of managing placenta accreta spectrum disorders is indispensable to reduce maternal morbidity and mortality afflicted by this grave condition. The said approach begins with identification of the risk factors of PAS occurrence, calculating pretest probability of PAS and thus early suspicion and referral can be offered by the widely applicable 2nd trimester anomaly scan. After confirming the diagnosis in the 3rd trimester, birthing plans are formulated according to the gravity of the condition assessed by the patient's clinical condition, the ultrasound scan signs, together with social factors as proximity to a healthcare facility capable of offering such management alongside the maternal take on prolonged hospitalization. Decision making and choosing the place of delivery is shared between the pregnant lady, her birth companion and her following up obstetrician. Since elective management of such cases has been proven to be associated with less adjacent organ injuries and associated morbidities, late preterm delivery is usually elected after a course of antenatal corticosteroids as per local protocol.

Guidelines concerned with PAS management still consider caesarean hysterectomy as the main management of placenta accreta disorders. Owing to the high rate of associated morbidity with caesarean hysterectomy, different researchers are hunting down updated recent management approaches with less morbidity and mortality.

Our study evaluated different outcomes with conservative management of placenta accreta spectrum disorders, namely, focal myometrium resection of the adherent defective myometrium along with its overlying placenta after devascularization, as opposed to caesarean hysterectomy. Data will be observed in a total of 36 PAS patients managed in the OBGYN department, in Kasr Al-Ainy School of medicine hospital, with 18 patients undergoing the previously explained conservative management and 18 patients undergoing caesarean hysterectomy. Demographic data of both study groups, alongside operative time, adjacent organ injury estimated blood loss, need for blood transfusion, Inotropic support and ICU admission will be collected, recorded and analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy with living fetus
  • Average liquor: 5-25 cm
  • Gestational age ≥ 34 weeks at time of termination
  • Previous lower segment cesarean section/s
  • Suspected placenta accreta spectrum.

Exclusion criteria

  • Hepatic, cardio-pulmonary or coagulation disorders
  • Hemoglobin< 9.5g/dl
  • Ruptured membranes
  • Need for emergency delivery as Antepartum hemorrhage or contractions
  • Placental abruption
  • Lower uterine segment fibroids
  • Consent withdrawal

Treatment and study plan

Caesarean Hysterectomy

Procedure

Caesarean delivery followed by hysterectomy

conservative management

Procedure

Focal myometrium resection of the area of diseased myometrium after delivery

Primary outcomes

  1. operative blood loss

    Time frame: 6 months

    hemoglobin deficit in mg/dl

Secondary outcomes

  1. operative blood loss

    Time frame: 6months

    visual estimation of operative blood loss in ml

  2. need for blood products transfusion

    Time frame: 6months

    no of blood products transfused in both groups in no. of units

  3. adjacent organ injuries

    Time frame: 6months

    rates of urinary bladder or ureteric injuries

  4. operative time

    Time frame: 6months

    operative time in minutes

  5. ICU admission

    Time frame: 6months

    need for ICU admission and length of stay in days

Study contacts

Contact information is provided by the study sponsor or research team.

ahmed elharty, MD

CONTACT

[email protected]

01063574555

aya elbeheiry

CONTACT

[email protected]

01276097367

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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