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NCT04866888·Not applicable·INTERVENTIONAL

Placenta Accreta Spectrum Outcome After Uterine Conservation

CarbetocinOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

120

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed description

After institutional review board approval and written informed consent, recruited cases will be subjected to the following: 1. 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. 2. Anthropometry including weight, height, and body mass index (BMI) before pregnancy and at the time of operation. 3. General examination including vital signs, and signs of any associated problems. 4. Routine laboratory investigations with particular emphasis on complete blood count, Coagulation profile and including blood glucose level, renal and liver function tests. 5. 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.

Interventions

Treatment arms and agents.

PROCEDURE

closure of the uterine wall defect

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.

DIAGNOSTIC_TEST

ultrasound

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.

DIAGNOSTIC_TEST

outpatient hysteroscopy

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.

Timeline

From registration to results.

  1. First posted

    Apr 30, 2021

  2. Study start

    Apr 28, 2021

  3. Primary completion

    Dec 1, 2025

  4. Study completion

    Mar 15, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Feb 12, 2025

Outcomes

What the study measures.

Primary outcomes

date of resumed menses

Time frame · from 2 weeks to 6 months after surgery

calculate the duration from surgery until menses returns

menstrual abnormalities

Time frame · from 2 to 6 months after surgery

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

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

pelvic pain

Time frame · from 2 to 6 months after surgery

record the presence of pelvic pain and its duration

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

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

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

contraception use

Time frame · intraoperative until 5 months after surgery

recording method of contraception used

Secondary outcomes

operation time

Time frame · intraoperative

recording total time of the surgery

repair time

Time frame · intraoperative

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

Estimated blood loss

Time frame · intraoperative

recording amount of blood loss

packed red blood cells transfusion

Time frame · intraoperative until 24 hours after surgery

recording amount of red blood cell transfused

fresh frozen plasma (FFP) transfusion

Time frame · intraoperative until 24 hours postoperative

recording amount of FFP transfusion

bladder injury

Time frame · intraoperative until 2 weeks post operative

recording if there was an injury to the bladder

ureter injury

Time frame · intraoperative until 2 weeks post operative

recording if there was an injury to the ureter

bowel injury

Time frame · intraoperative until 2 weeks post operative

recording if there was an injury to the bowel

surgical site infection

Time frame · 24 hours until 1 month after surgery

record the presence of wound infection

urine output

Time frame · intraoperative

recording amount of urine output

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Faculty of Medicine

Alexandria, Alexandria Governorate, Egypt

Publications

Results and literature.

PMID 39551821 ↗Elshorbagy OY, Hamdy MA. Conservative surgical repair of placenta increta invading into uterine septum: case report. J Med Case Rep. 2024 Nov 18;18(1):549. doi: 10.1186/s13256-024-04814-7.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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