Placenta Accreta, Third TrimesterNCT05191316
the Efficacy and Safety of the 3-steps Conservative Approach in the Management of Placenta Accreta Spectrum (a Novel Technique)
An observational study of Placenta Accreta, Third Trimester, run by Cairo University at 1 site in Egypt.
Trial summary
Placenta accrete spectrum (PAS) is an heterogeneous condition associated with a high maternal morbidity and mortality rate, presenting unique challenges in its diagnosis and management (Morlandoi et al., 2020). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta, Third Trimester
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 15 May 2022
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 28 pregnant females diagnosed with focal or partial PAS (placenta accreta/increta/percreta) undergoing 3rd trimester cesarean delivery.
Who may be able to join
- Patients aged 20-40 years old.
- Pregnant females with previous CS deliveries (at least 1) diagnosed with focal or partial PAS (placenta accreta/increta/percreta) candidate for 3rd trimester cesarean delivery.
- Patients wishing uterine conservation to preserve fertility.
- Gestational age: > 28 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan.
- Singleton pregnancies.
- CS under general anesthesia.
Who cannot join
- Maternal Anemia (hemoglobin < 10 g %).
- Chronic or pregnancy induced medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
- Patients presented with severe antepartum hemorrhage.
- Patients requested radical management (caesarean hysterectomy).
- Fetal death (IUFD).
- Fetal anomalies or IUGR (estimated fetal weight below the 5th centile).
- Women attending for emergency CS.
- Patients found to be suffering from placenta previa or total placenta accreta
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr al Ainy university, obstetrics and gynecology department
Cairo, Greater-cairo, 11562
hassan M Gaafar, M.D, 00201001588300, hassangaafar@kasralainy.edu.eg
About this study
Official title: the Efficacy and Safety of th 3-steps Conservative Approach in the Management of Placenta Accreta Spectrum (a Novel Technique)
Placenta accrete spectrum (PAS) is an heterogeneous condition associated with a high maternal morbidity and mortality rate, presenting unique challenges in its diagnosis and management (Morlandoi et al., 2020). PAS describes a clinical situation where the placenta does not detach spontaneously after delivery and cannot be forcibly removed without causing massive and potentially life-threatening bleeding (Jauniaux et al., 2018), in this study we study a novel 3-step technique for surgical conservative management of PAS, in terms of efficacy and safety.
Read the detailed description
- Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
- Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
- Thorough Clinical Examination: general (maternal body weight and vital signs) and full obstetric examination.
- Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study together with full placental assessment (diagnosis of PAS - placentation site and vasculature - extent of invasion to myometrial wall and surrounding structures as bladder wall invasion), with intra-operative confirmation aided by whether placental separation will occur or not.
- Preoperative laboratory tests: including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests.
- Operative steps: (A novel conservative 3 step technique)
- Patient positioning: under spinal anesthesia, the patient will be placed in the dorsal supine position. The patient will be then prepped and draped in the usual fashion for an abdominal procedure.
- A vertical midline incision will be done.
- Abdominal wall will be dissected in layers using sharp dissection or electro-coagulation instruments till the entry of peritoneal cavity.
- Dissection and release of the adherent bladder from the anterior uterine wall as low as possible (vesico-uterine peritoneal fold) together with the vascular disconnection of the newly formed vessels connecting the adherent invasive placenta to the urinary bladder. Dissection will be carried out laterally until both ureters are reached out and identified and in the midline until the lower edge of the placenta is identified.
- Transverse uterine incision above the upper border of placenta will be done followed by delivery of the fetus and immediate cord clamping (< 30 seconds) then the uterus will be exteriorized without trying to separate the adherent placenta and the uterine incision will be approximated by four towel clips (to reduce the blood loss).
- Placental bed devascularization (step 1): ligation of uterine arteries on two levels (one immediately under the lower level of placenta and another at least 5 mm above the upper edge of the adherent part of the placenta (superior-vesical arteries, feeding vessels of the placenta invading the back of the bladder will be also ligated).
- Cervical control sutures (step 2): transverse suture (full thickness) in the lower uterine segment at least 5 mm below the lower border of the placenta with or without similar stitch in the posterior uterine wall just above the uterosacral ligaments attachments.
- Delivery of the placenta with trimming of the invaded parts of the myometrium (step 3) followed by compression sutures taken in bleeding placental bed (if present) then myometrial reconstruction is done via continuous suture and mattress sutures.
- Bilateral ligation of the internal iliac arteries (4 cm distal to its origin) will be done if there is insufficient hemostasis is still present in spite of the above-mentioned steps to enhance further pelvic devascularization or if there's frank bladder invasion.
- In case of uncontrolled bleeding or failed the above-mentioned measures, hysterectomy will be done.
- Closure of abdominal wall in layers
- For all patients, 1 gm (10 ml) Tranexamic acid (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% will be given as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision in addition to 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will administered rectally together with catheter insertion. Following the delivery of the baby, patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500mL lactated Ringer's solution (infused at a rate of 125mL/h).
- The operative steps (operative procedure, operative time, time interval between skin incision and fetal delivery, internal iliac artery ligation) will be recorded. The number and the difference of weight of operative towels (before and after CS) and amount of blood in suction unit will be also recorded.
- The received blood units or blood products will be recorded (intra or postoperative).
- Fluid monitoring will be performed through rate of infusion and urine output.
- The neonatal outcome (APGAR at 1 and 5 minutes, NICU admission and neonatal death) will be recorded.
- A complete blood count will be performed 12 hours after delivery. All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), re-exploration with further surgical procedures, the need for additional blood transfusion (within the first 24 hours) or ICU admission.
- Estimated Blood Loss (EBL) was evaluated as follows:
- The number of operative towels used. B. The difference of weight of operative towels (before and after CS) plus the amount of blood in suction unit (we calculated 1 gram of weight difference equal to 1 ml blood loss).
- EBL calculation according to the following formula:
EBL= EBV x Preoperative hematocrit- Postoperative hematocrit Postoperative hematocrit Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
- At least 6 weeks post-operatively, a 2D and 3D ultrasonographic assessment of the uterus will be done, assessing the uterine cavity (the presence and extend of a uterine niche). Trans-abdominal ultrasound complimented with trans-vaginal ultrasound, by an expert, using a Voluson E8 Expert (GE Healthcare Ultrasound Korea, Ltd) ultrasound will be done. All ultrasound findings will be recorded.
- Patients who the 3-step management fail and are managed by a cesarean hysterectomy will be considered and recorded as failed and will be excluded from the study.
- In avoidance of false positive PAS, an intra-operative confirmation will be done, should full placental separation or complete placenta accrete be found, those patients will be excluded from the study.
- Conditions
- Placenta Accreta, Third Trimester
- Keywords
- surgical conservative management
- Medical subject headings
- Placenta Accreta
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of the 3-steps conservative approach as a novel technique in the management of PAS (measured using the percentage of successful surgical procedure among study population).
immediate and short term success of the 3-step conservative management technique
Measured: 6 weeks
Secondary outcomes (3)
estimated blood loss (EBL)
To evaluate the rate and amount of blood and blood product transfusion
Measured: pre and post operative
evaluate the rate of complication
primary postpartum hemorrhage, re-exploration with further surgical procedures, the need for additional blood transfusio or ICU admission.
Measured: first 24 hrs post operative
To evaluate the impact of the studied approach on the integrity of uterine cavity
(the presence of niche) follow up CS scar US examination for the presence of a uterine niche, which may affect future pregnancies.
Measured: 6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start15 Feb 2022 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta, Third TrimesterStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Essameldin Mohamed Abdullah, Cairo University
- Investigators
- Hassan M Gaafar, M.D, Principal investigator, prof. of obstetrics and gynecology (Faculty of medicine -Cairo university)Moataz M El-sherbini, M.D, Principal investigator, prof. of obstetrics and gynecology (Faculty of medicine -Cairo university)Abdalla m Mousa, M.D, Principal investigator, lecturer of obstetrics and gynecology (Faculty of medicine -Cairo university)mostafa E Abdalla, MRCOG, Principal investigator, Senior specialist clinical fellow, gynecology Guy's and St. Thomas's NHS TRUSTMazen m Abdel-rasheed, PhD, Principal investigator, reproductive health research department, national research centresondos m salem, PhD, Principal investigator, reproductive health research department, national research centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191316
- Sponsor's protocol ID
- MEMAbdullah
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy and Safety of th 3-steps Conservative Approach in the Management of Placenta Accreta Spectrum (a Novel Technique)
- ClinicalTrials.gov ID
- NCT05191316
- Acronym / sponsor ID
- MEMAbdullah
- Conditions
- Placenta Accreta, Third Trimester
- Keywords
- surgical conservative management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 13 Jan 2022 (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 accrete spectrum (PAS) is an heterogeneous condition associated with a high maternal morbidity and mortality rate, presenting unique challenges in its diagnosis and management (Morlandoi et al., 2020). PAS describes a clinical situation where the placenta does not detach spontaneously after delivery and cannot be forcibly removed without causing massive and potentially life-threatening bleeding (Jauniaux et al., 2018), in this study we study a novel 3-step technique for surgical conservative management of PAS, in terms of efficacy and safety.
Detailed description
- Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
- Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
- Thorough Clinical Examination: general (maternal body weight and vital signs) and full obstetric examination.
- Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study together with full placental assessment (diagnosis of PAS - placentation site and vasculature - extent of invasion to myometrial wall and surrounding structures as bladder wall invasion), with intra-operative confirmation aided by whether placental separation will occur or not.
- Preoperative laboratory tests: including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests.
- Operative steps: (A novel conservative 3 step technique)
- Patient positioning: under spinal anesthesia, the patient will be placed in the dorsal supine position. The patient will be then prepped and draped in the usual fashion for an abdominal procedure.
- A vertical midline incision will be done.
- Abdominal wall will be dissected in layers using sharp dissection or electro-coagulation instruments till the entry of peritoneal cavity.
- Dissection and release of the adherent bladder from the anterior uterine wall as low as possible (vesico-uterine peritoneal fold) together with the vascular disconnection of the newly formed vessels connecting the adherent invasive placenta to the urinary bladder. Dissection will be carried out laterally until both ureters are reached out and identified and in the midline until the lower edge of the placenta is identified.
- Transverse uterine incision above the upper border of placenta will be done followed by delivery of the fetus and immediate cord clamping (< 30 seconds) then the uterus will be exteriorized without trying to separate the adherent placenta and the uterine incision will be approximated by four towel clips (to reduce the blood loss).
- Placental bed devascularization (step 1): ligation of uterine arteries on two levels (one immediately under the lower level of placenta and another at least 5 mm above the upper edge of the adherent part of the placenta (superior-vesical arteries, feeding vessels of the placenta invading the back of the bladder will be also ligated).
- Cervical control sutures (step 2): transverse suture (full thickness) in the lower uterine segment at least 5 mm below the lower border of the placenta with or without similar stitch in the posterior uterine wall just above the uterosacral ligaments attachments.
- Delivery of the placenta with trimming of the invaded parts of the myometrium (step 3) followed by compression sutures taken in bleeding placental bed (if present) then myometrial reconstruction is done via continuous suture and mattress sutures.
- Bilateral ligation of the internal iliac arteries (4 cm distal to its origin) will be done if there is insufficient hemostasis is still present in spite of the above-mentioned steps to enhance further pelvic devascularization or if there's frank bladder invasion.
- In case of uncontrolled bleeding or failed the above-mentioned measures, hysterectomy will be done.
- Closure of abdominal wall in layers
- For all patients, 1 gm (10 ml) Tranexamic acid (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% will be given as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision in addition to 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will administered rectally together with catheter insertion. Following the delivery of the baby, patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500mL lactated Ringer's solution (infused at a rate of 125mL/h).
- The operative steps (operative procedure, operative time, time interval between skin incision and fetal delivery, internal iliac artery ligation) will be recorded. The number and the difference of weight of operative towels (before and after CS) and amount of blood in suction unit will be also recorded.
- The received blood units or blood products will be recorded (intra or postoperative).
- Fluid monitoring will be performed through rate of infusion and urine output.
- The neonatal outcome (APGAR at 1 and 5 minutes, NICU admission and neonatal death) will be recorded.
- A complete blood count will be performed 12 hours after delivery. All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), re-exploration with further surgical procedures, the need for additional blood transfusion (within the first 24 hours) or ICU admission.
- Estimated Blood Loss (EBL) was evaluated as follows:
- The number of operative towels used. B. The difference of weight of operative towels (before and after CS) plus the amount of blood in suction unit (we calculated 1 gram of weight difference equal to 1 ml blood loss).
- EBL calculation according to the following formula:
EBL= EBV x Preoperative hematocrit- Postoperative hematocrit Postoperative hematocrit Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
- At least 6 weeks post-operatively, a 2D and 3D ultrasonographic assessment of the uterus will be done, assessing the uterine cavity (the presence and extend of a uterine niche). Trans-abdominal ultrasound complimented with trans-vaginal ultrasound, by an expert, using a Voluson E8 Expert (GE Healthcare Ultrasound Korea, Ltd) ultrasound will be done. All ultrasound findings will be recorded.
- Patients who the 3-step management fail and are managed by a cesarean hysterectomy will be considered and recorded as failed and will be excluded from the study.
- In avoidance of false positive PAS, an intra-operative confirmation will be done, should full placental separation or complete placenta accrete be found, those patients will be excluded from the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 28 pregnant females diagnosed with focal or partial PAS (placenta accreta/increta/percreta) undergoing 3rd trimester cesarean delivery.
Key inclusion criteria (6 listed)
- Patients aged 20-40 years old.
- Pregnant females with previous CS deliveries (at least 1) diagnosed with focal or partial PAS (placenta accreta/increta/percreta) candidate for 3rd trimester cesarean delivery.
- Patients wishing uterine conservation to preserve fertility.
- Gestational age: > 28 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan.
- Singleton pregnancies.
Key exclusion criteria (8 listed)
- Maternal Anemia (hemoglobin < 10 g %).
- Chronic or pregnancy induced medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
- Patients presented with severe antepartum hemorrhage.
- Patients requested radical management (caesarean hysterectomy).
- Fetal death (IUFD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The efficacy of the 3-steps conservative approach as a novel technique in the management of PAS (measured using the percentage of successful surgical procedure among study population).
Time frame: 6 weeks
immediate and short term success of the 3-step conservative management technique
3 secondary outcomes
estimated blood loss (EBL)
Time frame: pre and post operative
evaluate the rate of complication
Time frame: first 24 hrs post operative
To evaluate the impact of the studied approach on the integrity of uterine cavity
Time frame: 6 weeks post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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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.
Hassan M Gaafar, M.D principal investigator
prof. of obstetrics and gynecology (Faculty of medicine -Cairo university)
Moataz M El-sherbini, M.D principal investigator
prof. of obstetrics and gynecology (Faculty of medicine -Cairo university)
Abdalla m Mousa, M.D principal investigator
lecturer of obstetrics and gynecology (Faculty of medicine -Cairo university)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, Third Trimester, run by Cairo University 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed E abdullah, M.B.B.S. (0020-100-311-3995, demk.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the 3-steps conservative approach as a novel technique in the management of PAS (measured using the percentage of successful surgical procedure among study population). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2022.