Placenta AccretaNCT06029985
Hysteroscopic Follow-up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta
An observational study of Placenta Accreta, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Conservative management of placenta accreta spectrum can preserve future fertility but should only be done in hospitals with enough experience as it carries a high risk of maternal complications. Follow up after conservative management is crucial to detect complications early. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Hysteroscopic Follow Up
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 31 Dec 2020
- 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 18 to 45 years
- Women only
- Adult
Study population: Women with one or more previous cesarean deliveries who were diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management in Ain shams maternity hospital
Who may be able to join
- Pregnant women with one or more previous cesarean deliveries
- Women diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management.
Who cannot join
- women who refused to participate in the study.
- Associated other medical conditions as pregnancy-induced hypertension, heart diseases, and rheumatological diseases apart from iron deficiency anemia.
- Presence of uterine anomalies
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 Prospective Case Series Study
Conservative management of placenta accreta spectrum can preserve future fertility but should only be done in hospitals with enough experience as it carries a high risk of maternal complications.
Follow up after conservative management is crucial to detect complications early.
Read the detailed description
Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of villous tissue invasiveness, placenta accreta was subdivided by pathologists into "creta", "increta", and "percreta", in which the villi adhere superficially to the myometrium without interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the entire uterine wall and may invade the surrounding pelvic organs, respectively.
The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes life-threatening hemorrhage, which often requires blood transfusion, increases maternal morbidity and mortality.
- Conditions
- Placenta Accreta
- Being tested
- Hysteroscopic Follow Up
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic Follow UpDiagnostic test
Office hysteroscopy was carried out to detect the scar site, performed with a 4-mm, continuous-flow operative hysteroscope by vaginoscopic approach, without analgesia or anesthesia. Distension of the uterus was obtained using a normal solution as distension medium, dispensed by an electronic suction/irrigation pump. This can maintain a constant intrauterine pressure of around 30-40 mmHg, balancing an irrigation flow of 200 mL/min with a vacuum of 0.2 bars, necessary to avoid overdistension of the muscle fibers and patient discomfort. The use of this distension medium allows blood or mucus to be washed out from the pouch if necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Easiness of hysteroscopy introduction
accessibility of hysteroscopic examination
Measured: 3-6 months
Adequacy of uterine cavity
visualization of the uterus will be assessed using office hysteroscopy
Measured: 3-6 months
intrauterine adhesions
visualization of the intrauterine adhesions will be assessed using office hysteroscopy
Measured: 3-6 months
cesarean scar niche
presence of a pouch, that forms on the wall of your uterus.
Measured: 3-6 months
Menstrual pattern
menstrual irregularities by history regarding Regular and normal volume or Regular and scanty or presence of Intermenstrual bleeding
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Jun 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Ghaleb, Ain Shams Maternity Hospital
- Investigators
- Mohamed Samy, MD, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029985
- Sponsor's protocol ID
- Hysteroscopic Follow-Up
- Status last verified
- Jan 2024
- First submitted
- 26 Aug 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 10 Jan 2024. 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: a Prospective Case Series Study
- ClinicalTrials.gov ID
- NCT06029985
- Acronym / sponsor ID
- Hysteroscopic Follow-Up
- Conditions
- Placenta Accreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Sep 2023 (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.
Conservative management of placenta accreta spectrum can preserve future fertility but should only be done in hospitals with enough experience as it carries a high risk of maternal complications.
Follow up after conservative management is crucial to detect complications early.
Detailed description
Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of villous tissue invasiveness, placenta accreta was subdivided by pathologists into "creta", "increta", and "percreta", in which the villi adhere superficially to the myometrium without interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the entire uterine wall and may invade the surrounding pelvic organs, respectively.
The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes life-threatening hemorrhage, which often requires blood transfusion, increases maternal morbidity and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with one or more previous cesarean deliveries who were diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management in Ain shams maternity hospital
Key inclusion criteria (2 listed)
- Pregnant women with one or more previous cesarean deliveries
- Women diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management.
Key exclusion criteria (3 listed)
- women who refused to participate in the study.
- Associated other medical conditions as pregnancy-induced hypertension, heart diseases, and rheumatological diseases apart from iron deficiency anemia.
- Presence of uterine anomalies
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 |
|---|---|---|
| Hysteroscopic Follow UpOffice hysteroscopy was carried out to detect the scar site, performed with a 4-mm, continuous-flow operative hysteroscope by vaginoscopic approach, without analgesia or anesthesia. Distension of the uterus was obtained using a normal solution as distension medium, dispensed by an electronic suction/irrigation pump. This can maintain a constant intrauterine pressure of around 30-40 mmHg, balancing an irrigation flow of 200 mL/min with a vacuum of 0.2 bars, necessary to avoid overdistension of the muscle fibers and patient discomfort. The use of this distension medium allows blood or mucus to be washed out from the pouch if necessary. | Diagnostic test | – |
Primary outcome
Easiness of hysteroscopy introduction
Time frame: 3-6 months
accessibility of hysteroscopic examination
Adequacy of uterine cavity
Time frame: 3-6 months
visualization of the uterus will be assessed using office hysteroscopy
intrauterine adhesions
Time frame: 3-6 months
visualization of the intrauterine adhesions will be assessed using office hysteroscopy
cesarean scar niche
Time frame: 3-6 months
presence of a pouch, that forms on the wall of your uterus.
Menstrual pattern
Time frame: 3-6 months
menstrual irregularities by history regarding Regular and normal volume or Regular and scanty or presence of Intermenstrual bleeding
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 10 Jan 2024.
- Individual participant dataSharing planned: No
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Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
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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.
Mohamed Samy, MD study director
Ain Shams Maternity Hospital
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, run by Ain Shams Maternity 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 2 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 10 Jan 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?
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?
Easiness of hysteroscopy introduction (time frame: 3-6 months). The study lists 5 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 10 Jan 2024.