Obstetric ComplicationNCT06861972
Caesarean Hysterectomy Versus Conservative Management of Placenta Accreta: A Comparative Study
An observational study of Obstetric Complication, run by Cairo University at 1 site in Egypt.
Trial summary
Placenta accreta rates are rising alongside the rising rates of caesarean deliveries. This has lead to a vast number of studies negotiating the histopathological nature, risk factors and outcomes of pregnancies complicated with placenta accreta. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obstetric Complication
- What is being tested?
- Caesarean Hysterectomy and Conservative management
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 Sep 2025
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: A total number of 36 pregnant patients at or after 34 weeks diagnosed of having placenta accreta spectrum were admitted and managed in Kasr Al-Ainy School of Medicine Hospital.
Who may be able to join
- Singleton pregnancy with living fetus
- Average liquor: 5-25 cm
- Gestational age ≥ 34 weeks at time of termination
- Previous lower segment cesarean section/s
- Suspected placenta accreta spectrum.
Who cannot join
- Hepatic, cardio-pulmonary or coagulation disorders
- Hemoglobin< 9.5g/dl
- Ruptured membranes
- Need for emergency delivery as Antepartum hemorrhage or contractions
- Placental abruption
- Lower uterine segment fibroids
- Consent withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Placenta accreta rates are rising alongside the rising rates of caesarean deliveries. This has lead to a vast number of studies negotiating the histopathological nature, risk factors and outcomes of pregnancies complicated with placenta accreta. In the study the investigators re discussing the outcome of different plans of management of placenta accreta, namely caesarean hysterectomy and focal myometrium resection.
Read the detailed description
Rising rates of caesarean delivery worldwide and especially in Egypt have affected higher rates of placenta accreta spectrum disorders. The increasing prevalence of this life-threatening condition can be primarily prevented by efforts targeted at reducing primary caesarean deliveries as well as encouraging trial of labor after caesarean deliveries of carefully selected gravidas in well-equipped hospitals, capable of providing continuous electronic fetal heart rate monitoring, along with offering one to one health care based systems with the capability of performing emergency caesarean deliveries when needed. As for secondary prevention, the best surgical approach to uterine incisions in caesarean deliveries is yet to be found and universally applied. The said approach will aim at decreasing short and long term complications of uterine scarification resulting in decreased number of placenta accreta cases and possibly downgrading their difficulty, too. Having failed to prevent such occurrence, optimization of PAS management can be attempted to try and decrease implicated injuries. As previously noted, multidisciplinary systematic approach of managing placenta accreta spectrum disorders is indispensable to reduce maternal morbidity and mortality afflicted by this grave condition. The said approach begins with identification of the risk factors of PAS occurrence, calculating pretest probability of PAS and thus early suspicion and referral can be offered by the widely applicable 2nd trimester anomaly scan. After confirming the diagnosis in the 3rd trimester, birthing plans are formulated according to the gravity of the condition assessed by the patient's clinical condition, the ultrasound scan signs, together with social factors as proximity to a healthcare facility capable of offering such management alongside the maternal take on prolonged hospitalization. Decision making and choosing the place of delivery is shared between the pregnant lady, her birth companion and her following up obstetrician. Since elective management of such cases has been proven to be associated with less adjacent organ injuries and associated morbidities, late preterm delivery is usually elected after a course of antenatal corticosteroids as per local protocol.
Guidelines concerned with PAS management still consider caesarean hysterectomy as the main management of placenta accreta disorders. Owing to the high rate of associated morbidity with caesarean hysterectomy, different researchers are hunting down updated recent management approaches with less morbidity and mortality.
Our study evaluated different outcomes with conservative management of placenta accreta spectrum disorders, namely, focal myometrium resection of the adherent defective myometrium along with its overlying placenta after devascularization, as opposed to caesarean hysterectomy. Data will be observed in a total of 36 PAS patients managed in the OBGYN department, in Kasr Al-Ainy School of medicine hospital, with 18 patients undergoing the previously explained conservative management and 18 patients undergoing caesarean hysterectomy. Demographic data of both study groups, alongside operative time, adjacent organ injury estimated blood loss, need for blood transfusion, Inotropic support and ICU admission will be collected, recorded and analyzed.
- Conditions
- Obstetric Complication
- Being tested
- Caesarean Hysterectomy, Conservative management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caesarean HysterectomyProcedure or surgery
Caesarean delivery followed by hysterectomy
Conservative managementProcedure or surgery
Focal myometrium resection of the area of diseased myometrium after delivery
| Study group | Role | What they receive |
|---|---|---|
| 1 (Caesarean Hysterectomy group) | patients with placenta accreta spectrum undergoing caesarean hysterectomy. Receives: Procedure: Caesarean Hysterectomy | |
| 2 ( Conservative Management group) | patients with placenta accreta spectrum undergoing focal myometrium resection Receives: Procedure: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative blood loss
hemoglobin deficit in mg/dl
Measured: 6 months
Secondary outcomes (5)
operative blood loss
visual estimation of operative blood loss in ml
Measured: 6months
need for blood products transfusion
no of blood products transfused in both groups in no. of units
Measured: 6months
adjacent organ injuries
rates of urinary bladder or ureteric injuries
Measured: 6months
operative time
operative time in minutes
Measured: 6months
ICU admission
need for ICU admission and length of stay in days
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElHarty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861972
- Sponsor's protocol ID
- MD-13-2023
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Collins SL, Chantraine F, Morgan TK, Jauniaux E. Abnormally adherent and invasive placenta: a spectrum disorder in need of a name. Ultrasound Obstet Gynecol. 2018 Feb;51(2):165-166. doi: 10.1002/uog.18982. No abstract available.
PubMed 29231264Nieto-Calvache AJ, Palacios-Jaraquemada JM, Osanan G, Cortes-Charry R, Aryananda RA, Bangal VB, Slaoui A, Abbas AM, Akaba GO, Joshua ZN, Vergara Galliadi LM, Nieto-Calvache AS, Sanin-Blair JE, Burgos-Luna JM; Latin American group for the study of placenta accreta spectrum. Lack of experience is a main cause of maternal death in placenta accreta spectrum patients. Acta Obstet Gynecol Scand. 2021 Aug;100(8):1445-1453. doi: 10.1111/aogs.14163. Epub 2021 May 24.
PubMed 33896009Jauniaux E, Jurkovic D. Placenta accreta: pathogenesis of a 20th century iatrogenic uterine disease. Placenta. 2012 Apr;33(4):244-51. doi: 10.1016/j.placenta.2011.11.010. Epub 2012 Jan 28.
PubMed 22284667
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caesarean Hysterectomy Versus Conservative Management of Placenta Accreta: A Comparative Study
- ClinicalTrials.gov ID
- NCT06861972
- Acronym / sponsor ID
- MD-13-2023
- Conditions
- Obstetric Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 Mar 2025 (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 accreta rates are rising alongside the rising rates of caesarean deliveries. This has lead to a vast number of studies negotiating the histopathological nature, risk factors and outcomes of pregnancies complicated with placenta accreta. In the study the investigators re discussing the outcome of different plans of management of placenta accreta, namely caesarean hysterectomy and focal myometrium resection.
Detailed description
Rising rates of caesarean delivery worldwide and especially in Egypt have affected higher rates of placenta accreta spectrum disorders. The increasing prevalence of this life-threatening condition can be primarily prevented by efforts targeted at reducing primary caesarean deliveries as well as encouraging trial of labor after caesarean deliveries of carefully selected gravidas in well-equipped hospitals, capable of providing continuous electronic fetal heart rate monitoring, along with offering one to one health care based systems with the capability of performing emergency caesarean deliveries when needed. As for secondary prevention, the best surgical approach to uterine incisions in caesarean deliveries is yet to be found and universally applied. The said approach will aim at decreasing short and long term complications of uterine scarification resulting in decreased number of placenta accreta cases and possibly downgrading their difficulty, too. Having failed to prevent such occurrence, optimization of PAS management can be attempted to try and decrease implicated injuries. As previously noted, multidisciplinary systematic approach of managing placenta accreta spectrum disorders is indispensable to reduce maternal morbidity and mortality afflicted by this grave condition. The said approach begins with identification of the risk factors of PAS occurrence, calculating pretest probability of PAS and thus early suspicion and referral can be offered by the widely applicable 2nd trimester anomaly scan. After confirming the diagnosis in the 3rd trimester, birthing plans are formulated according to the gravity of the condition assessed by the patient's clinical condition, the ultrasound scan signs, together with social factors as proximity to a healthcare facility capable of offering such management alongside the maternal take on prolonged hospitalization. Decision making and choosing the place of delivery is shared between the pregnant lady, her birth companion and her following up obstetrician. Since elective management of such cases has been proven to be associated with less adjacent organ injuries and associated morbidities, late preterm delivery is usually elected after a course of antenatal corticosteroids as per local protocol.
Guidelines concerned with PAS management still consider caesarean hysterectomy as the main management of placenta accreta disorders. Owing to the high rate of associated morbidity with caesarean hysterectomy, different researchers are hunting down updated recent management approaches with less morbidity and mortality.
Our study evaluated different outcomes with conservative management of placenta accreta spectrum disorders, namely, focal myometrium resection of the adherent defective myometrium along with its overlying placenta after devascularization, as opposed to caesarean hysterectomy. Data will be observed in a total of 36 PAS patients managed in the OBGYN department, in Kasr Al-Ainy School of medicine hospital, with 18 patients undergoing the previously explained conservative management and 18 patients undergoing caesarean hysterectomy. Demographic data of both study groups, alongside operative time, adjacent organ injury estimated blood loss, need for blood transfusion, Inotropic support and ICU admission will be collected, recorded and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Caesarean Hysterectomy group) | – | Procedure: Caesarean Hysterectomypatients with placenta accreta spectrum undergoing caesarean hysterectomy. |
| 2 ( Conservative Management group) | – | Procedure: Conservative managementpatients with placenta accreta spectrum undergoing focal myometrium resection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total number of 36 pregnant patients at or after 34 weeks diagnosed of having placenta accreta spectrum were admitted and managed in Kasr Al-Ainy School of Medicine Hospital.
Key inclusion criteria (5 listed)
- Singleton pregnancy with living fetus
- Average liquor: 5-25 cm
- Gestational age ≥ 34 weeks at time of termination
- Previous lower segment cesarean section/s
- Suspected placenta accreta spectrum.
Key exclusion criteria (7 listed)
- Hepatic, cardio-pulmonary or coagulation 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 |
|---|---|---|
| Caesarean HysterectomyCaesarean delivery followed by hysterectomy | Procedure or surgery | 1 (Caesarean Hysterectomy group) |
| Conservative managementFocal myometrium resection of the area of diseased myometrium after delivery | Procedure or surgery | 2 ( Conservative Management group) |
Primary outcome
operative blood loss
Time frame: 6 months
hemoglobin deficit in mg/dl
5 secondary outcomes
operative blood loss
Time frame: 6months
need for blood products transfusion
Time frame: 6months
adjacent organ injuries
Time frame: 6months
operative time
Time frame: 6months
ICU admission
Time frame: 6months
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 13 Aug 2026.
- Results publication: PubMed 29231264Collins SL, Chantraine F, Morgan TK, Jauniaux E. Abnormally adherent and invasive placenta: a spectrum disorder in need of a name. Ultrasound Obstet Gynecol. 2018 Feb;51(2):165-166. doi: 10.1002/uog.18982. No abstract available.
- Results publication: PubMed 33896009Nieto-Calvache AJ, Palacios-Jaraquemada JM, Osanan G, Cortes-Charry R, Aryananda RA, Bangal VB, Slaoui A, Abbas AM, Akaba GO, Joshua ZN, Vergara Galliadi LM, Nieto-Calvache AS, Sanin-Blair JE, Burgos-Luna JM; Latin American group for the study of placenta accreta spectrum. Lack of experience is a main cause of maternal death in placenta accreta spectrum patients. Acta Obstet Gynecol Scand. 2021 Aug;100(8):1445-1453. doi: 10.1111/aogs.14163. Epub 2021 May 24.
- Results publication: PubMed 22284667Jauniaux E, Jurkovic D. Placenta accreta: pathogenesis of a 20th century iatrogenic uterine disease. Placenta. 2012 Apr;33(4):244-51. doi: 10.1016/j.placenta.2011.11.010. Epub 2012 Jan 28.
- Kasr Alainy simplified uterine preserving surgery for conservative management of placenta accreta spectrumLink provided by the sponsor.
- Placenta accreta spectrum: a hysterectomy can be prevented in almost 80% of cases using a resective-reconstructive techniqueLink provided by the sponsor.
- Caesarean hysterectomyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Obstetric Complication, 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 5 inclusion and 7 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 13 Aug 2026. 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?
operative blood loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06861972, which also lists 3 linked publications.
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 Aug 2026.