Placenta AccretaNCT06465836
Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University
A study testing O, lreay suture and modified O, lreay suture in people with Placenta Accreta, run by Nesreen Abdel Fattah Abdullah Shehata at 1 site in Egypt.
Trial summary
To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- O, lreay suture and modified O, lreay suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 30 Jun 2025
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age more than 28 weeks as determined by LMP and ultrasound.
- Placenta previa as confirmed by ultrasound.
- Clinically stable with no or mild vaginal bleeding.
- No evidence of fetal compromise.
- Patient consent.
Who cannot join
- Vaginal bleeding
- Medical disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beni-Suef University Hospital Simplified Conservative Approach for Managing Placenta Accreta Spectrum: RCT
To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.
Read the detailed description
According to the International Federation of Gynecology and Obstetrics (FIGO) guidelines, the principal surgical strategy to prevent excessive bleeding related to placenta accreta syndrome is to leave the placenta in situ and perform a primary peripartum hysterectomy at delivery. A hysterectomy may not be preferred by patients wishing to preserve fertility and is detrimental to multiple aspects of the pelvic floor, bowel, and physical functions.
Surgical principles in placenta accreta syndrome include avoiding disruption of the hypervascular placenta, stepwise devascularization, early and comprehensive blood product transfusion, and judicious use of interventional radiologic techniques such as vascular embolization.
Conservative management describes any approach whereby hysterectomy is avoided
- Conditions
- Placenta Accreta
- Being tested
- O, lreay suture, modified O, lreay suture
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O, lreay sutureProcedure or surgery
bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly two large vicryl stitches were passed using a large sized needle below and lateral to the lower edge of the uterine incision angle in anteroposterior direction and then redirected from back to the front through avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly
modified O, lreay sutureProcedure or surgery
- Pack Douglas- pouch with a towel.
- Straight the used vicryl needle mostly no 1.
- Try to compress and approximate anterior and posterior uterine walls.
- Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. And we repeat the procedure on the other side. We can repeat this method of uterine ligation at another different plane if needed.
| Study group | Role | What they receive |
|---|---|---|
| O- lreay technique group | Other | Group A: In which 86 patients will have bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly, two large vicryl stitches were passed using a large-sized needle below and lateral to the lower edge of the uterine incision angle in an anteroposterior direction and then redirected from back to the front through the avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly Receives: Procedure: O, lreay suture |
| Modified O- lreay technique group | Other | Group B: which will include 86 patients we will do our simplified approach which includes;
* After placental separation; try to grasp the lower segment or cervical flap.
* Close uterine cavity by continuous vicryl no 1 suture.
* Do 3 to 4 mattress sutures as the second layer of the uterus.
* Do uterine ligation with compression of the lower uterine segment (Modification of O, lreay suture) as demonstrated below:
1. Pack Douglas- pouch with a towel.
2. Straight the used vicryl needle mostly no 1.
3. Try to compress and approximate anterior and posterior uterine walls.
4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. Receives: Procedure: modified O, lreay suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss
The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.
Measured: 6 hours postoperatively
Secondary outcomes (2)
Maternal morbidity
Coagulopathy, need for massive blood transfusion (> 4 units), length of hospital stay, and visceral injuries ICU admission and post-operative pain.
Measured: 24 hours post operatively
Maternal mortality
Maternal death
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start15 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Patients will be randomized into two groups. One of two intraoperative surgical interventions that will be evolved during the study period: Group A: In which 86 patients will have bilateral uterine artery ligations as described by the O- lreay technique in addition to standard conservative methods. The stitches were tied securely anteriorly. Group B: which will include 86 patients we will do our simplified approach which include; * After placental separation; try to grasp lower segment, or cervical flap. * Close uterine cavity by continuous vicryl no 1 suture. * Do 3 to 4 mattress sutures as the second layer of the uterus. * Do uterine ligation with compression of the lower uterine segment (Modification of O, lreay suture).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nesreen Abdel Fattah Abdullah Shehata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465836
- Sponsor's protocol ID
- Morbidly adherent placenta
- Status last verified
- Jun 2024
- First submitted
- 12 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beni-Suef University Hospital Simplified Conservative Approach for Managing Placenta Accreta Spectrum: RCT
- ClinicalTrials.gov ID
- NCT06465836
- Acronym / sponsor ID
- Morbidly adherent placenta
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Nesreen Abdel Fattah Abdullah ShehataUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Jun 2024 (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.
To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.
Detailed description
According to the International Federation of Gynecology and Obstetrics (FIGO) guidelines, the principal surgical strategy to prevent excessive bleeding related to placenta accreta syndrome is to leave the placenta in situ and perform a primary peripartum hysterectomy at delivery. A hysterectomy may not be preferred by patients wishing to preserve fertility and is detrimental to multiple aspects of the pelvic floor, bowel, and physical functions.
Surgical principles in placenta accreta syndrome include avoiding disruption of the hypervascular placenta, stepwise devascularization, early and comprehensive blood product transfusion, and judicious use of interventional radiologic techniques such as vascular embolization.
Conservative management describes any approach whereby hysterectomy is avoided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups. One of two intraoperative surgical interventions that will be evolved during the study period: Group A: In which 86 patients will have bilateral uterine artery ligations as described by the O- lreay technique in addition to standard conservative methods. The stitches were tied securely anteriorly. Group B: which will include 86 patients we will do our simplified approach which include; * After placental separation; try to grasp lower segment, or cervical flap. * Close uterine cavity by continuous vicryl no 1 suture. * Do 3 to 4 mattress sutures as the second layer of the uterus. * Do uterine ligation with compression of the lower uterine segment (Modification of O, lreay suture).
| Arm | Type | Receives |
|---|---|---|
| O- lreay technique group | Other | Procedure: O, lreay sutureGroup A: In which 86 patients will have bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly, two large vicryl stitches were passed using a large-sized needle below and lateral to the lower edge of the uterine incision angle in an anteroposterior direction and then redirected from back to the front through the avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly |
| Modified O- lreay technique group | Other | Procedure: modified O, lreay sutureGroup B: which will include 86 patients we will do our simplified approach which includes; * After placental separation; try to grasp the lower segment or cervical flap. * Close uterine cavity by continuous vicryl no 1 suture. * Do 3 to 4 mattress sutures as the second layer of the uterus. * Do uterine ligation with compression of the lower uterine segment (Modification of O, lreay suture) as demonstrated below: 1. Pack Douglas- pouch with a towel. 2. Straight the used vicryl needle mostly no 1. 3. Try to compress and approximate anterior and posterior uterine walls. 4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age more than 28 weeks as determined by LMP and ultrasound.
- Placenta previa as confirmed by ultrasound.
- Clinically stable with no or mild vaginal bleeding.
- No evidence of fetal compromise.
- Patient consent.
Key exclusion criteria (2 listed)
- Vaginal bleeding
- Medical disorders
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 |
|---|---|---|
| O, lreay suturebilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly two large vicryl stitches were passed using a large sized needle below and lateral to the lower edge of the uterine incision angle in anteroposterior direction and then redirected from back to the front through avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly | Procedure or surgery | O- lreay technique group |
| modified O, lreay suture1. Pack Douglas- pouch with a towel. 2. Straight the used vicryl needle mostly no 1. 3. Try to compress and approximate anterior and posterior uterine walls. 4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. And we repeat the procedure on the other side. We can repeat this method of uterine ligation at another different plane if needed. | Procedure or surgery | Modified O- lreay technique group |
Primary outcome
Amount of blood loss
Time frame: 6 hours postoperatively
The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.
2 secondary outcomes
Maternal morbidity
Time frame: 24 hours post operatively
Maternal mortality
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O, lreay suture and modified O, lreay suture in people with Placenta Accreta, run by Nesreen Abdel Fattah Abdullah Shehata 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 5 inclusion and 2 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 20 Jun 2024. 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 Hamada Ali, A. professor (0201007240754, hamadaashry@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood loss (time frame: 6 hours postoperatively). 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 20 Jun 2024.