Placenta Accreta Spectrum Outcome After Uterine Conservation

Not Applicable

Recruiting

• Conditions: Placenta Accreta Spectrum
• Interventions: Procedure: closure of the uterine wall defect; Diagnostic Test: ultrasound; Diagnostic Test: outpatient hysteroscopy

• Registration Number: NCT04866888
• Lead Sponsor: Alexandria University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study Start: 2021-04-28
• Study First Posted: 2021-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pregnant women with placenta accreta spectrum	closure of the uterine wall defect	Bladder will be dissected and mobilized down to the vagina after skeletonization and securing of bridging vessels either by electro-coagulation or ligation. Uterus will be incised 5mm above the placenta bulge, delivering the fetus followed by Carbetocin 100 microgram /1 ml intravascular. Repair of the uterine wall defect will be done. If extrauterine bleeding is excessive we may revert to internal iliac artery ligation followed by insertion of intra-peritoneal drain and regular abdominal wall closure. After 3 months from delivery, ultrasound with different modalities will be done to all patients and outpatient hysteroscopy if symptomatic patients or with abnormal sonography.
pregnant women with placenta accreta spectrum	outpatient hysteroscopy	Bladder will be dissected and mobilized down to the vagina after skeletonization and securing of bridging vessels either by electro-coagulation or ligation. Uterus will be incised 5mm above the placenta bulge, delivering the fetus followed by Carbetocin 100 microgram /1 ml intravascular. Repair of the uterine wall defect will be done. If extrauterine bleeding is excessive we may revert to internal iliac artery ligation followed by insertion of intra-peritoneal drain and regular abdominal wall closure. After 3 months from delivery, ultrasound with different modalities will be done to all patients and outpatient hysteroscopy if symptomatic patients or with abnormal sonography.
pregnant women with placenta accreta spectrum	ultrasound	Bladder will be dissected and mobilized down to the vagina after skeletonization and securing of bridging vessels either by electro-coagulation or ligation. Uterus will be incised 5mm above the placenta bulge, delivering the fetus followed by Carbetocin 100 microgram /1 ml intravascular. Repair of the uterine wall defect will be done. If extrauterine bleeding is excessive we may revert to internal iliac artery ligation followed by insertion of intra-peritoneal drain and regular abdominal wall closure. After 3 months from delivery, ultrasound with different modalities will be done to all patients and outpatient hysteroscopy if symptomatic patients or with abnormal sonography.

Primary Outcome Measures

Name	Time	Method
abnormal uterine bleeding	from 2 to 6 months after surgery	record the presence of abnormal uterine bleeding after the return of menses such as intermenstrual bleeding, menorrhagia
isthmocele	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
date of resumed menses	from 2 weeks to 6 months after surgery	calculate the duration from surgery until menses returns
puerperal blood loss	48 hours until 2 months after surgery	recording the duration of blood loss during puerperium and average number of tampons changed per day
menstrual abnormalities	from 2 to 6 months after surgery	record type of menstrual abnormalities if present such as amenorrhea, oligomenorrhea and dysmenorrhea
pelvic pain	from 2 to 6 months after surgery	record the presence of pelvic pain and its duration
intrauterine adhesions	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
contraception use	intraoperative until 5 months after surgery	recording method of contraception used
fibrosis	from 3 to 6 months after surgery	grey scale ultrasound will be done to record size of intra-myometrium fibrosis

Secondary Outcome Measures

Name	Time	Method
packed red blood cells transfusion	intraoperative until 24 hours after surgery	recording amount of red blood cell transfused
fresh frozen plasma (FFP) transfusion	intraoperative until 24 hours postoperative	recording amount of FFP transfusion
post-operative hemoglobin	postoperative within 6 hours from surgery	recording amount of hemoglobin
ureter injury	intraoperative until 2 weeks post operative	recording if there was an injury to the ureter
surgical site infection	24 hours until 1 month after surgery	record the presence of wound infection
hospital stay	postoperative until 10 days after surgery	recording duration of hospital stay after surgery
ICU admission	immediate postoperative until 5 days after surgery	recording the number of patients admitted to the ICU
pre-operative hemoglobin	preoperative	recording amount of hemoglobin
intermediate care admission	recording the number of patients admitted to the ICU	recording the number of patients admitted to the intermediate care
operation time	intraoperative	recording total time of the surgery
repair time	intraoperative	recording length of defect repair from placental separation until uterine wall closure
bowel injury	intraoperative until 2 weeks post operative	recording if there was an injury to the bowel
Estimated blood loss	intraoperative	recording amount of blood loss
bladder injury	intraoperative until 2 weeks post operative	recording if there was an injury to the bladder
urine output	intraoperative	recording amount of urine output
internal iliac artery ligation	intraoperative	recording if the internal iliac artery ligated whether it was unilateral or bilateral
surgical diagnosis	intraoperative	document the type of placenta accreta spectrum whether it is accreta, increta or percreta and area of the uterus where the placental invade

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt