Placenta AccretaNCT04579172
Conservative Management of Morbidly Adherent Anterior Situated Placenta
A study testing Cervico- isthmic compression suture and Anterior wall uterine resection: in people with Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Placenta accreta is defined as abnormal trophoblast invasion of part or the entire placenta into the myometrium of the uterine wall. Placenta accreta spectrum (PAS), formerly known as morbidly adherent placenta, refers to the range of pathologic adherence of the placenta, including placenta increta, percreta, and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Cervico- isthmic compression suture and Anterior wall uterine resection:
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1- Patient with FIGO classification of PAS disorders Grade 1 \& Grade 2 which diagnosed by :
- Loss of normal hypoechoic retroplacental zone.
- Multiple vascular lacunae (irregular vascular spaces) within placenta, giving "Swiss cheese" appearance.
- Retroplacental myometrial thickness of less 1 mm. 2- Patient welling to preserve fertility.
Who cannot join
- 1- Patient with FIGO classification of PAS disorders Grade 3 (interruption of the hyperechoic border between the uterine serosa and bladder by US).
- 2- Age : >40 years old. 3- Patient has medical disorders: cardiac disease, uncontrolled DM, chronic renal disease, chronic liver disease.
- 4- Patient who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervico-Isthmic Compression Suture Versus Anterior Wall Uterine Resection in Cases of Morbidly Adherent Anterior Situated Placenta
Placenta accreta is defined as abnormal trophoblast invasion of part or the entire placenta into the myometrium of the uterine wall. Placenta accreta spectrum (PAS), formerly known as morbidly adherent placenta, refers to the range of pathologic adherence of the placenta, including placenta increta, percreta, and accreta.
An important risk factor of placenta accreta is placenta previa in the presence of a uterine scar. Placenta previa is an independent risk factor for placenta accreta.Additional reported risk factors for placenta accreta include increased maternal age and multiparity, other prior uterine surgery, prior uterine curettage,uterine irradiation, Asherman syndrome, uterine leiomyomata, uterine anomalies, hypertensive disorders of pregnancy and smoking. (1,2) Maternal morbidity and mortality can occur because of severe and sometimes life-threatening hemorrhage, which often requires blood transfusion also and rates of maternal death are increased for women with PAS. Additionally, patients with PAS are more likely to require hysterectomy at the time of delivery or during the postpartum period and have longer hospital stays states.(3) According to FIGO Classification of PAS Disorders 2019 There are three grades. Grade 1: abnormally adherent placenta (placenta adherent or accreta) - attached directly to the surface of the middle layer of the uterine wall (myometrium) without invading it, Grade 2: abnormally invasive placenta (increta) - invasion into the myometrium and Grade 3: abnormally invasive placenta (percreta) invasion may reach surrounding pelvic tissues, vessels and organs.(4) Nowadays, fertility sparing and conservative methods can be applied. These methods include placenta left in situ, cervical inversion technique , triple-P procedure, cervico-isthmic compression suture and anterior wall uterine resection
Read the detailed description
Study Design \& Area:
Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals during September 2020 until September 2021 and may be extended if needed.
The study groups will undergo:
Informed consent
History:
Personal: (age, duration of marriage, special habits). Menstrual history Obstetric: (parity, mode of delivery, fetal outcome). Present history of any medical or obstetric problems. Past medical and surgical history. Clinical examination : General and obstetric examination
Calculation of Gestational Age :
Gestational age will be calculated by adding 280 days (40weeks) to the first day of the last menstrual period or by ultrasound.
Investigation:
Lab investigation:- Complete blood count , Bleeding profile, international normalization ratio, liver function tests, kidney function tests
Ultrasound:
Ultrasound Finding:- i. Establish the presence of a living fetus. ii. Estimate the age of the pregnancy. iii. Diagnose congenital abnormalities of the fetus. iv. Evaluate the position of the fetus. v. Determine the amount of amniotic fluid around the baby. vi. Assess fetal growth. vii. Assess fetal well-being. viii. Evaluate the position of the placenta.
- When the antepartum diagnosis of placenta accreta is made, it is usually based on ultrasound findings in the second or third trimester. Sonographic findings that may be suggestive of placenta accreta include:
- Loss of normal hypoechoic retroplacental zone.
- Multiple vascular lacunae (irregular vascular spaces) within placenta, giving "Swiss cheese" appearance.
- Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface.
- Retroplacental myometrial thickness of <1 mm. 3 - Color Doppler criteria:
- Diffuse or focal lacunar flow pattern.
- Sonolucent vascular lakes with turbulent flow typified by high-velocity (peak systolic velocity>15 cm/s) and low-resistance waveform.
- Markedly dilated vessels over the peripheral subplacental region (6)
Surgical Procedure:
Preparation of the patient before surgery:
- Patient will shave their pubic hair , take a shower with an antiseptic soap, antibiotic prophylaxis and urinary catheter insertion .
- Caesarean section steps :
After spinal anesthesia and skin sterilization Abdominal Incision: Pfannenstiel incision then cut the subcutaneous fat and rectus sheath and blunt entry into the peritoneal cavity .
- Conditions
- Placenta Accreta
- Being tested
- Cervico- isthmic compression suture, Anterior wall uterine resection:
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervico- isthmic compression sutureProcedure or surgery
Circular isthmic-cervical sutures will be applied . To avoid ureter and bladder injury, the bladder will be reflected downward. A silastic drain will be inserted into internal and through the external os , so as to drain the uterine cavity and to keep the cervical canal open. Firstly, at the left side of the uterus, a Vicryl number two (No..2) stitch will be inserted very close to the cervix from the anterior to the posterior side of the broad ligament.
Anterior wall uterine resection:Procedure or surgery
After fetal delivery, two corners of the uterine incision and the superior and inferior lips will be clamped immediately by four Mayo clamps. Blunt dissection downward to the bladder-uterus peritoneal reflection will perform, to the partial anterior wall of the uterine myometrium where the placenta was deeply adherent (a myometrium defect, with only the serous layer of the uterus) will be respected, together with the placenta. It is important to ensure that sufficient myometrium above the peritoneal reflection will be available for an optimum closure. Then, as much remaining placenta as possible will be removed piecemeal from the edge of the uterine incision. Clamps and multiple hemostatic sutures will be applied rapidly
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Circular isthmic-cervical sutures Receives: Procedure: Cervico- isthmic compression suture |
| Group B | Experimental | Resection of the infiltrated part of anterior uterine wall Receives: Procedure: Anterior wall uterine resection: |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated blood loss
- The amount of blood drawn into the storage jar during surgery (suction apparatus).
- The weight of blood-soaked gauze pads, gauzes, and surgical dressings minus their preoperative weight, and corresponding conversion according to the proportion of 1.05 g in weight to 1 ml in volume.
Measured: from the start of uterine incision till closure of uterine wall
Secondary outcomes (2)
hemoglobin deficit
Compare hemoglobin and hematocrit values before and after operation.
Measured: from the induction of anesthesia till 2 hours after the end of surgery
complication rate
- Injury to local organs (e.g., bowel, bladder, uterus and neurovascular structures in the retroperitoneum and lateral pelvic sidewalls from placental implantation and its removal).
- Postpartum hemorrhage, Internal hemorrhage.
- Amniotic fluid embolism.
- Massive blood transfusion: acidosis, hypothermia, coagulopathy, electrolyte abnormalities and infection.
- Postoperative thromboembolism, infection, multisystem organ failure, and maternal death
- Hysterectomy.
Measured: from the start of induction of anesthesia till 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start30 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- \- Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals for elective termination of pregnancy
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Taman, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579172
- Sponsor's protocol ID
- MS.20.09.1246
- Status last verified
- Apr 2022
- First submitted
- 1 Oct 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761.
PubMed 31173360Jauniaux E, Kingdom JC, Silver RM. A comparison of recent guidelines in the diagnosis and management of placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:102-116. doi: 10.1016/j.bpobgyn.2020.06.007. Epub 2020 Jun 27.
PubMed 32698993Zhao X, Tao Y, Du Y, Zhao L, Liu C, Zhou Y, Wei P. The application of uterine wall local resection and reconstruction to preserve the uterus for the management of morbidly adherent placenta: Case series. Taiwan J Obstet Gynecol. 2018 Apr;57(2):276-282. doi: 10.1016/j.tjog.2018.02.017.
PubMed 29673673
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervico-Isthmic Compression Suture Versus Anterior Wall Uterine Resection in Cases of Morbidly Adherent Anterior Situated Placenta
- ClinicalTrials.gov ID
- NCT04579172
- Acronym / sponsor ID
- MS.20.09.1246
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placenta accreta is defined as abnormal trophoblast invasion of part or the entire placenta into the myometrium of the uterine wall. Placenta accreta spectrum (PAS), formerly known as morbidly adherent placenta, refers to the range of pathologic adherence of the placenta, including placenta increta, percreta, and accreta.
An important risk factor of placenta accreta is placenta previa in the presence of a uterine scar. Placenta previa is an independent risk factor for placenta accreta.Additional reported risk factors for placenta accreta include increased maternal age and multiparity, other prior uterine surgery, prior uterine curettage,uterine irradiation, Asherman syndrome, uterine leiomyomata, uterine anomalies, hypertensive disorders of pregnancy and smoking. (1,2) Maternal morbidity and mortality can occur because of severe and sometimes life-threatening hemorrhage, which often requires blood transfusion also and rates of maternal death are increased for women with PAS. Additionally, patients with PAS are more likely to require hysterectomy at the time of delivery or during the postpartum period and have longer hospital stays states.(3) According to FIGO Classification of PAS Disorders 2019 There are three grades. Grade 1: abnormally adherent placenta (placenta adherent or accreta) - attached directly to the surface of the middle layer of the uterine wall (myometrium) without invading it, Grade 2: abnormally invasive placenta (increta) - invasion into the myometrium and Grade 3: abnormally invasive placenta (percreta) invasion may reach surrounding pelvic tissues, vessels and organs.(4) Nowadays, fertility sparing and conservative methods can be applied. These methods include placenta left in situ, cervical inversion technique , triple-P procedure, cervico-isthmic compression suture and anterior wall uterine resection
Detailed description
Study Design \& Area:
Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals during September 2020 until September 2021 and may be extended if needed.
The study groups will undergo:
Informed consent
History:
Personal: (age, duration of marriage, special habits). Menstrual history Obstetric: (parity, mode of delivery, fetal outcome). Present history of any medical or obstetric problems. Past medical and surgical history. Clinical examination : General and obstetric examination
Calculation of Gestational Age :
Gestational age will be calculated by adding 280 days (40weeks) to the first day of the last menstrual period or by ultrasound.
Investigation:
Lab investigation:- Complete blood count , Bleeding profile, international normalization ratio, liver function tests, kidney function tests
Ultrasound:
Ultrasound Finding:- i. Establish the presence of a living fetus. ii. Estimate the age of the pregnancy. iii. Diagnose congenital abnormalities of the fetus. iv. Evaluate the position of the fetus. v. Determine the amount of amniotic fluid around the baby. vi. Assess fetal growth. vii. Assess fetal well-being. viii. Evaluate the position of the placenta.
- When the antepartum diagnosis of placenta accreta is made, it is usually based on ultrasound findings in the second or third trimester. Sonographic findings that may be suggestive of placenta accreta include:
- Loss of normal hypoechoic retroplacental zone.
- Multiple vascular lacunae (irregular vascular spaces) within placenta, giving "Swiss cheese" appearance.
- Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface.
- Retroplacental myometrial thickness of <1 mm. 3 - Color Doppler criteria:
- Diffuse or focal lacunar flow pattern.
- Sonolucent vascular lakes with turbulent flow typified by high-velocity (peak systolic velocity>15 cm/s) and low-resistance waveform.
- Markedly dilated vessels over the peripheral subplacental region (6)
Surgical Procedure:
Preparation of the patient before surgery:
- Patient will shave their pubic hair , take a shower with an antiseptic soap, antibiotic prophylaxis and urinary catheter insertion .
- Caesarean section steps :
After spinal anesthesia and skin sterilization Abdominal Incision: Pfannenstiel incision then cut the subcutaneous fat and rectus sheath and blunt entry into the peritoneal cavity .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- - Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals for elective termination of pregnancy
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Cervico- isthmic compression sutureCircular isthmic-cervical sutures |
| Group B | Experimental | Procedure: Anterior wall uterine resection:Resection of the infiltrated part of anterior uterine wall |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1- Patient with FIGO classification of PAS disorders Grade 1 \& Grade 2 which diagnosed by :
Key exclusion criteria (3 listed)
- 1- Patient with FIGO classification of PAS disorders Grade 3 (interruption of the hyperechoic border between the uterine serosa and bladder by US).
- 2- Age : >40 years old. 3- Patient has medical disorders: cardiac disease, uncontrolled DM, chronic renal disease, chronic liver disease.
- 4- Patient who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervico- isthmic compression sutureCircular isthmic-cervical sutures will be applied . To avoid ureter and bladder injury, the bladder will be reflected downward. A silastic drain will be inserted into internal and through the external os , so as to drain the uterine cavity and to keep the cervical canal open. Firstly, at the left side of the uterus, a Vicryl number two (No..2) stitch will be inserted very close to the cervix from the anterior to the posterior side of the broad ligament. | Procedure or surgery | Group A |
| Anterior wall uterine resection:After fetal delivery, two corners of the uterine incision and the superior and inferior lips will be clamped immediately by four Mayo clamps. Blunt dissection downward to the bladder-uterus peritoneal reflection will perform, to the partial anterior wall of the uterine myometrium where the placenta was deeply adherent (a myometrium defect, with only the serous layer of the uterus) will be respected, together with the placenta. It is important to ensure that sufficient myometrium above the peritoneal reflection will be available for an optimum closure. Then, as much remaining placenta as possible will be removed piecemeal from the edge of the uterine incision. Clamps and multiple hemostatic sutures will be applied rapidly | Procedure or surgery | Group B |
Primary outcome
estimated blood loss
Time frame: from the start of uterine incision till closure of uterine wall
1. The amount of blood drawn into the storage jar during surgery (suction apparatus). 2. The weight of blood-soaked gauze pads, gauzes, and surgical dressings minus their preoperative weight, and corresponding conversion according to the proportion of 1.05 g in weight to 1 ml in volume.
2 secondary outcomes
hemoglobin deficit
Time frame: from the induction of anesthesia till 2 hours after the end of surgery
complication rate
Time frame: from the start of induction of anesthesia till 24 hours after the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 31173360Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761.
- Background: PubMed 32698993Jauniaux E, Kingdom JC, Silver RM. A comparison of recent guidelines in the diagnosis and management of placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:102-116. doi: 10.1016/j.bpobgyn.2020.06.007. Epub 2020 Jun 27.
- Background: PubMed 29673673Zhao X, Tao Y, Du Y, Zhao L, Liu C, Zhou Y, Wei P. The application of uterine wall local resection and reconstruction to preserve the uterus for the management of morbidly adherent placenta: Case series. Taiwan J Obstet Gynecol. 2018 Apr;57(2):276-282. doi: 10.1016/j.tjog.2018.02.017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervico- isthmic compression suture and Anterior wall uterine resection: in people with Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimated blood loss (time frame: from the start of uterine incision till closure of uterine wall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579172, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.