Health TrialsbyHealthPanel

Placenta Accreta Spectrum Outcome After Uterine Conservation

ConditionPlacenta Accreta Spectrum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorAlexandria University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Diagnosed sonographically to have placenta accreta spectrum.

Pregnancy is singleton and fetus is alive.

Elective caesarean section done from 35 gestational weeks.

Disqualifiers

• Patients requesting hysterectomy.

Coexisting uterine pathology such as fibroids or gynaecological malignancies.

Patients with bleeding diathesis.

Morbid obesity of BMI >40.

Trial design

Design model

Single group

Treatments tested in this trial

  • closure of the uterine wall defect

    Procedure/Surgery

    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.

  • 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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: pregnant women with placenta accreta spectrumExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

date of resumed menses

calculate the duration from surgery until menses returns

Time frame
from 2 weeks to 6 months after surgery
2

menstrual abnormalities

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

Time frame
from 2 to 6 months after surgery
3

abnormal uterine bleeding

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

Time frame
from 2 to 6 months after surgery
4

pelvic pain

record the presence of pelvic pain and its duration

Time frame
from 2 to 6 months after surgery

Secondary outcomes

1

operation time

recording total time of the surgery

Time frame
intraoperative
2

repair time

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

Time frame
intraoperative
3

Estimated blood loss

recording amount of blood loss

Time frame
intraoperative
4

packed red blood cells transfusion

recording amount of red blood cell transfused

Time frame
intraoperative until 24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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