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NCT Number: NCT04866888

Placenta Accreta Spectrum Outcome After Uterine Conservation

study will be carried out on patients with placenta accreta spectrum having done uterine conservation and recording immediate outcome of conservation regarding success of the procedure, amount of blood loss and amount of blood transfused and followed up to check the return of menses, any uterine abnormalities by ultrasound or hysteroscopy especially isthmocele and intrauterine synechia.

Recruiting

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Alexandria, Alexandria Governorate, 21131, Egypt

Location status: Recruiting

Location contact

Omar Y Elshorbagy, AS.LEC

PRINCIPAL_INVESTIGATOR

omar Y Elshorbagy, AS.LEC

CONTACT

[email protected]

01111362322 ext. 002

About this study

After institutional review board approval and written informed consent, recruited cases will be subjected to the following:

  • Data registration including:
  • Age.
  • Obstetric history including gravidity, parity, number of previous cesarean deliveries, and number and gender of living children.
  • Details of the current pregnancy including duration in menstrual weeks, any problems encountered during its course.
  • Desire for future fertility.
  • Medical, surgical, and medication history.
  • Anthropometry including weight, height, and body mass index (BMI) before pregnancy and at the time of operation.
  • General examination including vital signs, and signs of any associated problems.
  • Routine laboratory investigations with particular emphasis on complete blood count, Coagulation profile and including blood glucose level, renal and liver function tests.
  • Detailed sonographic examination to evaluate fetal biometry, and wellbeing rule out exclusion factors, and confirm diagnosis of PAS and assess the degree of invasion, and its severity using both trans-abdominal transducer with frequency of 2-5 megahertz (MHZ) and trans-vaginal transducer with frequency of 4-10 MHZ.

Intraoperative details will be documented. Follow up of patients will be recorded. Sample size was calculated by estimating a single proportion distribution at a significance level of 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Diagnosed sonographically to have placenta accreta spectrum.
  • Pregnancy is singleton and fetus is alive.
  • Elective caesarean section done from 35 gestational weeks.

Exclusion criteria

  • • Patients requesting hysterectomy.
  • Coexisting uterine pathology such as fibroids or gynaecological malignancies.
  • Patients with bleeding diathesis.
  • Morbid obesity of BMI >40.
  • Patients having labour pains or vaginal bleeding before scheduled intervention.

Treatment and study plan

closure of the uterine wall defect

Procedure

Uterine exteriorization followed by pealing of amniotic membranes to reach an accessible pole of the placenta to detect a plan of cleavage behind it. The independent hand of the surgeon passed through the previous plan from points of least resistance to high resistance. The defect will be repaired from the inner aspect of the uterus via running sutures using Vicryl (1-0) on a round needle, 45mm. the suture will pass from one edge to hitch the bed and pass to the other edge till we completely close the defect subsequently, controlling the bleeding. Uterine scar closure by running sutures in two layers, where the first layer compresses the placental bed defect externally.

Other names: double compression sutures

Ultrasound

Diagnostic Test

Before the procedure transabdominal and transvaginal ultrasound will be done to diagnose PAS and to map the uterine wall defects.

After 3 months,Transabdominal and transvaginal ultrasound with different modalities to assess the uterine wall, the cavity, endometrium, myometrium and the cervix. Isthmocele will be defined as a defect at uterine wall where residual myometrium thickness and ratio between residual myometrium and total myometrium thickness will be measured and recorded. The shape of the isthmocele will be also recorded.

outpatient hysteroscopy

Diagnostic Test

Office hysteroscope will be done after patient consent to evaluate the uterine cavity if the patient is symptomatic or with abnormal sonography. It will be performed in the proliferative phase of the menstrual cycle. Non-steroidal anti-inflammatory will be given one hour before the procedure, then the patient will be in lithotomy position. Following aseptic rules, the rigid 4 mm hysteroscope will be inserted into the uterus through the cervix without using speculum nor tenaculum. Any pathology will be identified, and data will be recorded.

Other names: office hysteroscopy

Primary outcomes

  1. date of resumed menses

    Time frame: from 2 weeks to 6 months after surgery

    calculate the duration from surgery until menses returns

  2. menstrual abnormalities

    Time frame: from 2 to 6 months after surgery

    record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea

  3. abnormal uterine bleeding

    Time frame: from 2 to 6 months after surgery

    record the presence of abnormal uterine bleeding after the return of menses such as intermenstrual bleeding, menorrhagia

  4. pelvic pain

    Time frame: from 2 to 6 months after surgery

    record the presence of pelvic pain and its duration

  5. isthmocele

    Time frame: from 3 to 6 months after surgery

    trans-vaginal and trans-abdominal ultrasound will be done to record the presence of isthmocele, its shape and ratio between residual myometrium and total myometrium

  6. intrauterine adhesions

    Time frame: from 3 to 6 months after surgery

    outpatient hysteroscopy will be done to symptomatic patients after consent in order to check uterine cavity recording the presence of intrauterine adhesions, and categorization of adhesions according to american fertility society into mild, moderate and severe

  7. puerperal blood loss

    Time frame: 48 hours until 2 months after surgery

    recording the duration of blood loss during puerperium and average number of tampons changed per day

  8. contraception use

    Time frame: intraoperative until 5 months after surgery

    recording method of contraception used

  9. fibrosis

    Time frame: from 3 to 6 months after surgery

    grey scale ultrasound will be done to record size of intra-myometrium fibrosis

Secondary outcomes

  1. operation time

    Time frame: intraoperative

    recording total time of the surgery

  2. repair time

    Time frame: intraoperative

    recording length of defect repair from placental separation until uterine wall closure

  3. Estimated blood loss

    Time frame: intraoperative

    recording amount of blood loss

  4. packed red blood cells transfusion

    Time frame: intraoperative until 24 hours after surgery

    recording amount of red blood cell transfused

  5. fresh frozen plasma (FFP) transfusion

    Time frame: intraoperative until 24 hours postoperative

    recording amount of FFP transfusion

  6. bladder injury

    Time frame: intraoperative until 2 weeks post operative

    recording if there was an injury to the bladder

  7. ureter injury

    Time frame: intraoperative until 2 weeks post operative

    recording if there was an injury to the ureter

  8. bowel injury

    Time frame: intraoperative until 2 weeks post operative

    recording if there was an injury to the bowel

  9. surgical site infection

    Time frame: 24 hours until 1 month after surgery

    record the presence of wound infection

  10. urine output

    Time frame: intraoperative

    recording amount of urine output

  11. internal iliac artery ligation

    Time frame: intraoperative

    recording if the internal iliac artery ligated whether it was unilateral or bilateral

  12. pre-operative hemoglobin

    Time frame: preoperative

    recording amount of hemoglobin

  13. post-operative hemoglobin

    Time frame: postoperative within 6 hours from surgery

    recording amount of hemoglobin

  14. hospital stay

    Time frame: postoperative until 10 days after surgery

    recording duration of hospital stay after surgery

  15. ICU admission

    Time frame: immediate postoperative until 5 days after surgery

    recording the number of patients admitted to the ICU

  16. intermediate care admission

    Time frame: recording the number of patients admitted to the ICU

    recording the number of patients admitted to the intermediate care

  17. surgical diagnosis

    Time frame: intraoperative

    document the type of placenta accreta spectrum whether it is accreta, increta or percreta and area of the uterus where the placental invade

Study contacts

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

Omar Y Elshorbagy, As.lec

CONTACT

[email protected]

01111362322 ext. 002

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum

Acronym: PAS

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 30, 2021
Registry last updated
Feb 12, 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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