Placenta AccretaNCT04981483
Conservative Surgery for Placenta Accreta
A study testing conservative surgery for uterus in placenta accreta in people with Placenta Accreta, run by Ain Shams University at 1 site in Egypt.
Trial summary
A stepwise surgical approach for conservative management of placenta previa accreta. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- conservative surgery for uterus in placenta accreta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Jun 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any age.
- Any parity.
- Previous one or more cesarean delivery.
- Placenta previa accreta diagnosis confirmed by gray scale \& color flow Doppler ultrasound in 3rd trimester. All participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by U/S
Who cannot join
- women with medical disorder
- women with bleeding tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta
A stepwise surgical approach for conservative management of placenta previa accreta.
Read the detailed description
a stepwise surgical approach for conservative management of placenta previa accreta to preserve women's uterus and to evaluate the efficacy and safety of this approach in controlling postpartum hemorrhage including intrapartum hemorrhage associated with conservative management.
- Conditions
- Placenta Accreta
- Being tested
- conservative surgery for uterus in placenta accreta
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative surgery for uterus in placenta accretaProcedure or surgery
After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner
| Study group | Role | What they receive |
|---|---|---|
| Any age and parity with placenta accreta spectrum | Experimental | After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner Receives: Procedure: conservative surgery for uterus in placenta accreta |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of conserving woman's uterus
success rate of conservative surgery for placenta accreta
Measured: intraoperative
Secondary outcomes (3)
number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin
to assess blood loss
Measured: till 48 hours postpartum
incidence rate of cesarean hysterectomy needed
failure of conservation , increase in blood loss
Measured: intraoperative and 48 hours postpartum
incidence of puerperal sepsis
temperature chart every 6 hours in 1st 48 hours postpartum then follow up visits 2 weeks and 6 weeks postpartum
Measured: till 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jan 2018
- Primary completion15 Apr 2019
- Study completion30 Jun 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed mahmoud samy, Ain Shams University
- Investigators
- mahmoud ghaleb, lecturer, Study director, ainshams university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981483
- Sponsor's protocol ID
- 11784
- Status last verified
- Dec 2023
- First submitted
- 6 Jul 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta
- ClinicalTrials.gov ID
- NCT04981483
- Acronym / sponsor ID
- 11784
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Jul 2021 (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.
A stepwise surgical approach for conservative management of placenta previa accreta.
Detailed description
a stepwise surgical approach for conservative management of placenta previa accreta to preserve women's uterus and to evaluate the efficacy and safety of this approach in controlling postpartum hemorrhage including intrapartum hemorrhage associated with conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Any age and parity with placenta accreta spectrum | Experimental | Procedure: conservative surgery for uterus in placenta accretaAfter removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any age.
- Any parity.
- Previous one or more cesarean delivery.
- Placenta previa accreta diagnosis confirmed by gray scale \& color flow Doppler ultrasound in 3rd trimester. All participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by U/S
Key exclusion criteria (2 listed)
- women with medical disorder
- women with bleeding tendency
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 |
|---|---|---|
| conservative surgery for uterus in placenta accretaAfter removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner | Procedure or surgery | Any age and parity with placenta accreta spectrum |
Primary outcome
incidence rate of conserving woman's uterus
Time frame: intraoperative
success rate of conservative surgery for placenta accreta
3 secondary outcomes
number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin
Time frame: till 48 hours postpartum
incidence rate of cesarean hysterectomy needed
Time frame: intraoperative and 48 hours postpartum
incidence of puerperal sepsis
Time frame: till 6 weeks postpartum
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 29 Dec 2023.
- Individual participant dataSharing planned: No
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Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
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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.
mahmoud ghaleb, lecturer study director
ainshams university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative surgery for uterus in placenta accreta in people with Placenta Accreta, run by Ain Shams 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 4 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: finished, as of the sponsor's last update on 29 Dec 2023. 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?
incidence rate of conserving woman's uterus (time frame: intraoperative). 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 29 Dec 2023.