Placenta AccretaNCT05471102
Ligation of Anterior Internal Iliac Artery With Conservative Management of Partial or Focal Placenta Accreta Spectrum
A study testing Study group: lower segment resection with ligation of the anterior division of the internal iliac artery in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
The patients will be divided into 2 groups: Group (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery Group (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Study group: lower segment resection with ligation of the anterior division of the internal iliac artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2022to 31 Jan 2024
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-40 years old.
- Pregnancy of singleton living fetus.
- Previous one or more cesarean sections.
- Gestational age: > 36 weeks.
- Elective termination of pregnancy.
- Cases not requiring preoperative blood transfusion.
- Cases with focal area of placental adherence or invasion leaving sufficient healthy myometrial tissue for uterine repair and preservation.
- The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesical hypervascularity".
Who cannot join
- Multifetal pregnancy.
- More than four previous sections.
- Emergency termination of pregnancy due to antepartum hemorrhage, placental separation or rupture uterus.
- Intrauterine fetal death.
- Women with history of any medical disorder with pregnancy eg. Gestational diabetes and hypertension.
- Premature rupture of membranes.
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- Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative. "will be excluded before randomization"
- Cases with PAS with total invasion involving all placental lobules.
- Cases who will be managed by cesarean hysterectomy due to uncontrolled intraoperative bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Ligation of the Anterior Division of the Internal Iliac Artery in Conservative Management of Patients Diagnosed With Partial or Focal Placenta Accreta Spectrum
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery
Read more
Group (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery
The following operative details will be recorded:
- Estimation of total blood loss
- Pre and 24-h post-operative hemoglobin (g/dl).
- The need for blood transfusion and its amount intra or postoperative will be recorded
- Operative time and postoperative hospital stay will be recorded.
- Close post-operative monitoring of the patients' vital signs, drain output, and urine output
- Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
- Monitoring for postoperative morbidities
Read the detailed description
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by uterine lower segment resection with ligation of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery).
Group (B) - Control group: Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery.
In both groups, bilateral uterine artery ligation at 2 levels will be done; bilateral ligation at a level below the lower most placental part, followed by bilateral uterine artery ligation at the level of the hysterotomy incision.
The following operative details will be recorded:
- Estimation of total blood loss
- Pre and 24-h post-operative hemoglobin (g/dl).
- The need for blood transfusion and its amount intra or post-operative will be recorded
- Operative time and postoperative hospital stay will be recorded.
- Close post-operative monitoring of the patients' vital signs, drain output, and urine output
- Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
- Monitoring for postoperative morbidities
- Conditions
- Placenta Accreta
- Being tested
- Study group: lower segment resection with ligation of the anterior division of the internal iliac artery, Control group: lower segment resection without ligation of the anterior division of the internal iliac artery
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study group: lower segment resection with ligation of the anterior division of the internal iliac arteryProcedure or surgery
Cases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision.
Control group: lower segment resection without ligation of the anterior division of the internal iliac arteryProcedure or surgery
Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Cases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision. Receives: Procedure: Study group: lower segment resection with ligation of the anterior division of the internal iliac artery |
| Control group | Placebo comparator | Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision). Receives: Procedure: Control group: lower segment resection without ligation of the anterior division of the internal iliac artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss intra-operative
Amount of blood loss intra-operative
Measured: during operation
Amount of blood loss 24 hours post-operative
Amount of blood loss 24 hours post-operative
Measured: 24 hours post-operative
Secondary outcomes (2)
Operative time
duration of the surgery
Measured: during operation
Number of blood units transfused
Number of blood units transfused within 24 hours after surgery
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start3 Jul 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471102
- Sponsor's protocol ID
- MS-38-2022
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2022
- Last updated
- 30 Jul 2025
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ligation of the Anterior Division of the Internal Iliac Artery in Conservative Management of Patients Diagnosed With Partial or Focal Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT05471102
- Acronym / sponsor ID
- MS-38-2022
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Jul 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.
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery
Group (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery
The following operative details will be recorded:
- Estimation of total blood loss
- Pre and 24-h post-operative hemoglobin (g/dl).
- The need for blood transfusion and its amount intra or postoperative will be recorded
- Operative time and postoperative hospital stay will be recorded.
- Close post-operative monitoring of the patients' vital signs, drain output, and urine output
- Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
- Monitoring for postoperative morbidities
Detailed description
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by uterine lower segment resection with ligation of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery).
Group (B) - Control group: Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery.
In both groups, bilateral uterine artery ligation at 2 levels will be done; bilateral ligation at a level below the lower most placental part, followed by bilateral uterine artery ligation at the level of the hysterotomy incision.
The following operative details will be recorded:
- Estimation of total blood loss
- Pre and 24-h post-operative hemoglobin (g/dl).
- The need for blood transfusion and its amount intra or post-operative will be recorded
- Operative time and postoperative hospital stay will be recorded.
- Close post-operative monitoring of the patients' vital signs, drain output, and urine output
- Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
- Monitoring for postoperative morbidities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Study group: lower segment resection with ligation of the anterior division of the internal iliac arteryCases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision. |
| Control group | Placebo comparator | Procedure: Control group: lower segment resection without ligation of the anterior division of the internal iliac arteryCases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 20-40 years old.
- Pregnancy of singleton living fetus.
- Previous one or more cesarean sections.
- Gestational age: > 36 weeks.
- Elective termination of pregnancy.
Key exclusion criteria (9 listed)
- Multifetal pregnancy.
- More than four previous sections.
- Emergency termination of pregnancy due to antepartum hemorrhage, placental separation or rupture uterus.
- Intrauterine fetal death.
- Women with history of any medical disorder with pregnancy eg. Gestational diabetes and hypertension.
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 |
|---|---|---|
| Study group: lower segment resection with ligation of the anterior division of the internal iliac arteryCases managed by uterine lower segment resection with ligation ((suturing)) of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery); in addition to the bilateral uterine artery ligation at 2 levels; bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision. | Procedure or surgery | Study group |
| Control group: lower segment resection without ligation of the anterior division of the internal iliac arteryCases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery. (i.e., only bilateral ligation at a level below the lower most placental part followed by bilateral uterine artery ligation at the level of the hysterotomy incision). | Procedure or surgery | Control group |
Primary outcome
Amount of blood loss intra-operative
Time frame: during operation
Amount of blood loss intra-operative
Amount of blood loss 24 hours post-operative
Time frame: 24 hours post-operative
Amount of blood loss 24 hours post-operative
2 secondary outcomes
Operative time
Time frame: during operation
Number of blood units transfused
Time frame: within 24 hours after 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 30 Jul 2025.
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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 Study group: lower segment resection with ligation of the anterior division of the internal iliac artery in people with Placenta Accreta, 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 8 inclusion and 9 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 30 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
Amount of blood loss intra-operative (time frame: during operation). The study lists 2 primary outcomes in all. 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 30 Jul 2025.