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Completed

NCT Number: NCT04427592

New Conservative Technique for Placenta Accreta Spectrum

participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.

Investigators manually detected a plan of cleavage through which the placenta was separated followed by closure of defective placental bed.

Data were collected about the outcome.

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Key information

Conditions

Placenta Accreta Spectrum Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Alexandria, 21131, Egypt

About this study

Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to help sure diagnosis of PAS.

Cesarean section will be performed through extended transverse supra-pubic incision bladder dissection from anterior uterine wall using electro-coagulation instruments and double ligation of large caliber bridging vessels.

Uterine incision above the placental bulge by at least 5 mm then complete separation of the placenta starting from least resistance plans to high resistant one leaving a clear defect which will be closed by running sutures from inside the uterus and controlling placental bed hemorrhage then closing the uterine incision with compressing the bed from outwards ( double compression sutures ) internal Iliac artery ligation may be done as a complementary measure to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain and closure of abdominal wall in layers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pregnant women diagnosed as placenta accreta spectrum with previous Cesarean section, with or without other uterine surgeries and less than 40 years of age.

Exclusion criteria

  • pregnant women having medical conditions such as cardiac diseases, coagulopathy and hematological disorders.

pregnant women had 5 or more previous Cesarean sections or their age more than 40 years

Treatment and study plan

Ultrasound

Diagnostic Test

trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode

closure of uterine wall defect

Procedure

uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.

Other names: Double compression suture

Primary outcomes

  1. surgical outcome

    Time frame: from the time of the surgery until 48 hours after.

    number of participants whom their uterus were preserved without major hemorrhage

  2. intra-operative blood loss

    Time frame: intraoperative

    the amount of blood loss during operation was estimated for each participant.

  3. surgical complications

    Time frame: intraoperative

    number of participants had bladder, ureter injury or hysterectomy,

  4. internal iliac artery ligation

    Time frame: intra-operative

    number of participants had with either unilateral or bilateral internal iliac artery ligation

  5. high dependency unit admission

    Time frame: from 0 to 48 hours postoperative

    number of participants needed high dependency unit admission

  6. wound complications

    Time frame: up to 2 weeks postoperative

    number of patients suffered wound infection

  7. change in the hemoglobin level

    Time frame: from 48 hours pre operative to 48 hours post operative

    participant's hemoglobin was measured

  8. blood transfusion

    Time frame: from 48 hours preoperative to 48 hours postoperative.

    number of units of blood and it's products transfused to participants

  9. hematuria

    Time frame: post-operative up to 24 hours

    number of participants suffered hematuria

  10. manual cervical assesment

    Time frame: before skin incision

    participants were subjected to vaginal examination to asses the cervix lenght

  11. placental separation

    Time frame: intra-operative

    number of participants whom their placenta was separated manually

  12. surgical grading of the placenta

    Time frame: intra-operative

    number of participants who had accreta, increta, percreta or mixed type

  13. ultrasound grading of the placenta

    Time frame: pre-operative

    number of participants who were diagnosed by ultrasound as accreta, increta or percreta

  14. manual assessment of vaginal fornices

    Time frame: before skin incision

    participants were subjected to vaginal examination to assess fornices

  15. repair time

    Time frame: intra-operative

    the time recorded from the end of the placental separation to the closure of the first layer of the uterus

  16. total operation time

    Time frame: intra-operative

    the time taken from the start of the skin incision to the skin closure

Secondary outcomes

  1. placental bed

    Time frame: intra-operative

    number of participants that investigators detected a well delineated placental bed like a pouch

  2. pouch site

    Time frame: intra-operative

    the site of the pouch in relation to the cervix

  3. defect site

    Time frame: intra-operative

    the location of the myometrium defects

Other outcomes

  1. new ultrasound sign the pouch

    Time frame: pre-operative

    number of participants that the investigators detected the previously noticed pouch by ultrasound.

  2. significance of the pouch

    Time frame: peri-operative

    the investigators determine the relation of the pouch to estimated blood loss

  3. Pathology

    Time frame: From the operation time for 48 hours

    Histopathological examination of 1 cm specimen from the myometriam attached to the placenta in random cases

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Placenta Accreta; A Vision for Conservative Surgery

Acronym: percreta

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2020
Registry last updated
Dec 6, 2023

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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