Placenta AccretaNCT04264169
Risk Factors for Occurrence of Placenta Accrete Spectrum Following Primary Cesarean Delivery
An observational study of Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
This study will be conducted on a group of patients undergoing repeat elective caesarean delivery attending at Mansoura university hospital. This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one caesarean delivery in the period… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 21 Jan 2021
- How long will I take part?
- 1 Week
- 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: This study will be conducted on a group of patients undergoing repeat elective cesarean delivery attending at Mansoura university hospital. - This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery
Who may be able to join
- Patients with history of previous one caesarean delivery
- Patients who refused trail of vaginal birth after caesarean section
- Patients with permanent indication for caesarean section like contracted pelvis
- Patient without any history of medical diseases
Who cannot join
- Patients with history of more than one previous caesarean delivery
- Patients with medical disorders complicating pregnancy kike preeclampsia and gestational diabetes mellitus
- Patients with known uterine abnormalities eg (Bicornuate uterus, Adenomyosis, Submucous fibroids and Myotonic dystrophy)
- Patients who are candidates for vaginal birth after caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted on a group of patients undergoing repeat elective caesarean delivery attending at Mansoura university hospital.
- This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one caesarean delivery in the period between (January 2020 till January 2021).
Read the detailed description
Participants in this study will be a group of patients with past history of previous one caesarean delivery and attending for elective termination of the current pregnancy.
Patients data will be collected and analysed as following:
- Personal data: Age, residency, job, special habits, BMI
- Past obstetric history:
Gravidity, parity, full term normal delivery, full term assisted vaginal deliveries, preterm, stillbirth, abortion, previous pregnancy complication and complication during puerperium • Previous delivery: Indication, duration, place of delivery, results of delivery, complication during labour, complication during puerperium
- Past medical, surgical or gynaecological history
- Pregnancy by assisted reproductive techniques
- Current pregnancy complications
- Trans abdominal and trans vaginal ultrasound examination Patients will be considered to have placenta praevia if the lower edge of the placenta is less than 2 cm form the internal os of the cervix
Placenta accreta will be considered as the following(7, 8) (Placental lacunae, Loss of hypoechoic space, Abnormalities of uterus-bladder interface, Color Doppler abnormalities)
2D grey-scale Loss of the "clear zone" Loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed (the "clear zone") Abnormal placental lacunae Presence of numerous lacunae including some that are large and irregular (Fin berg grade 3) often containing turbulent flow visible in grey-scale imaging Bladder wall interruption Loss or interruption of the bright bladder wall (the hyperechoic band or "line" between the uterine serosa and the bladder lumen) Myometrial thinning Thinning of the myometrium overlying the placenta to <1 mm or undetectable Placental bulge Deviation of the uterine serosa away from the expected plane, caused by an abnormal bulge of placental tissue into a neighbouring organ, typically the bladder. The uterine serosa appears intact but the outline shape is distorted Focal exophytic mass Placental tissue seen breaking through the uterine serosa and extending beyond it. Most often seen inside a filled urinary bladder Color Doppler imaging Uterovesical hypervascularity Striking amount of colour Doppler signal seen between the myometrium and the posterior wall of the bladder. This sign probably indicates numerous, closely packed, tortuous vessels in that region (demonstrating multi-directional flow and aliasing artifact) Subplacental hypervascularity Striking amount of color Doppler signal seen in the placental bed. This sign probably indicates numerous,closely packed, tortuous vessels in that region (demonstrating multidirectional flow and aliasing artifact)
Bridging vessels Vessels appearing to extend from the placenta across the myometrium and beyond the serosa into the bladder or other organs. Often running perpendicular to the myometrium
Placental lacunae feeder vessels Vessels with high velocity blood flow leading from the myometrium into the placental lacunae, causing turbulence upon entry
At laparotomy the following data will be reviewed(6):
Grade 1: Abnormally adherent placenta (placenta adherenta or accreta)
- Macroscopically, the uterus shows no obvious distension over the placental bed (placental "bulge"), no placental tissue is seen invading through the surface of the uterus, and there is no or minimal neovascularity Grade 2: Abnormally invasive placenta (Increta)
- Abnormal macroscopic findings over the placental bed: bluish/purple colouring, distension (placental "bulge")
- Significant amounts of hypervascularity (dense tangled bed of vessels or multiple vessels running parallel craniocaudially in the uterine serosa)
- No placental tissue seen to be invading through the uterine serosa.
- Gentle cord traction results in the uterus being pulled inwards without separation of the placenta (so-called the dimple sign) Histologic criteria
- Hysterectomy specimen or partial myometrial resection of the increta area shows placental villi within the muscular fibers and sometimes in the lumen of the deep uterine vasculature (radial or arcuate arteries) Grade 3: Abnormally invasive placenta (Percreta) Grade 3a: Limited to the uterine serosa Clinical criteria
- At laparotomy
- Abnormal macroscopic findings on uterine serosal surface (as above) and placental tissue seen to be invading through the surface of the uterus
- No invasion into any other organ, including the posterior wall of the bladder (a clear surgical plane can be identified between the bladder and uterus)
- Histologic criteria
- Hysterectomy specimen showing villous tissue within or breaching the uterine serosa Grade 3b: With urinary bladder invasion Clinical criteria
- At laparotomy
- Placental villi are seen to be invading into the bladder but no other organs
- Clear surgical plane cannot be identified between the bladder and uterus Histologic criteria
- Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading the bladder wall tissue or urothelium Grade 3c: With invasion of other pelvic tissue/organs Clinical criteria
- At laparotomy
- Placental villi are seen to be invading into the broad ligament, vaginal wall, pelvic sidewall or any other pelvic organ (with or without invasion of the bladder) Histologic criteria • Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading pelvic tissues/organs (with or without invasion of the bladder) .For the purposes of this classification, "uterus" includes the uterine body and uterine cervix .
- The data will be analysed after putting it in the following groups,
- study group consisted of patients with placenta praevia diagnosed by TVUS, control group consisted of patients undergoing elective caesarean delivery without having placenta praevia by transvaginal ultrasound (TVUS) examination
- Conditions
- Placenta Accreta
- Keywords
- placenta accrete spectrum, ultrasound, Risk factors
- 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 | Role | What they receive |
|---|---|---|
| • Study group | 100 patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery and the current pregnancy will be complicated by placenta accreta spectrum | |
| • Control group | 100 patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery and the current pregnancy will not be complicated by placenta accreta spectrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum
association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum
Measured: 1 day
Secondary outcomes (1)
the association between parity, gravidity, place of the primary Cesarean delivery, assisted conception, and vaginal delivery before and after the primary Cesarean delivery,postpartum complications and degree of placenta accreta spectrum
the association between parity, gravidity, place of the primary Cesarean delivery, assisted conception, and vaginal delivery before and after the primary Cesarean delivery ,postpartum complications and degree of placenta accreta spectrum
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Taman, Mansoura University Hospital
- Investigators
- Mohamed E Taman, MD, Principal investigator, Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264169
- Sponsor's protocol ID
- R.19.12.685
- Status last verified
- Jan 2021
- First submitted
- 7 Feb 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Individual data sharing
- No
Publications
Jauniaux E, Chantraine F, Silver RM, Langhoff-Roos J; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Epidemiology. Int J Gynaecol Obstet. 2018 Mar;140(3):265-273. doi: 10.1002/ijgo.12407. No abstract available.
PubMed 29405321
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Occurrence of Placenta Accrete Spectrum Following Primary Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04264169
- Acronym / sponsor ID
- R.19.12.685
- Conditions
- Placenta Accreta
- Keywords
- placenta accrete spectrum, ultrasound, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 11 Feb 2020 (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.
This study will be conducted on a group of patients undergoing repeat elective caesarean delivery attending at Mansoura university hospital.
- This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one caesarean delivery in the period between (January 2020 till January 2021).
Detailed description
Participants in this study will be a group of patients with past history of previous one caesarean delivery and attending for elective termination of the current pregnancy.
Patients data will be collected and analysed as following:
- Personal data: Age, residency, job, special habits, BMI
- Past obstetric history:
Gravidity, parity, full term normal delivery, full term assisted vaginal deliveries, preterm, stillbirth, abortion, previous pregnancy complication and complication during puerperium • Previous delivery: Indication, duration, place of delivery, results of delivery, complication during labour, complication during puerperium
- Past medical, surgical or gynaecological history
- Pregnancy by assisted reproductive techniques
- Current pregnancy complications
- Trans abdominal and trans vaginal ultrasound examination Patients will be considered to have placenta praevia if the lower edge of the placenta is less than 2 cm form the internal os of the cervix
Placenta accreta will be considered as the following(7, 8) (Placental lacunae, Loss of hypoechoic space, Abnormalities of uterus-bladder interface, Color Doppler abnormalities)
2D grey-scale Loss of the "clear zone" Loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed (the "clear zone") Abnormal placental lacunae Presence of numerous lacunae including some that are large and irregular (Fin berg grade 3) often containing turbulent flow visible in grey-scale imaging Bladder wall interruption Loss or interruption of the bright bladder wall (the hyperechoic band or "line" between the uterine serosa and the bladder lumen) Myometrial thinning Thinning of the myometrium overlying the placenta to <1 mm or undetectable Placental bulge Deviation of the uterine serosa away from the expected plane, caused by an abnormal bulge of placental tissue into a neighbouring organ, typically the bladder. The uterine serosa appears intact but the outline shape is distorted Focal exophytic mass Placental tissue seen breaking through the uterine serosa and extending beyond it. Most often seen inside a filled urinary bladder Color Doppler imaging Uterovesical hypervascularity Striking amount of colour Doppler signal seen between the myometrium and the posterior wall of the bladder. This sign probably indicates numerous, closely packed, tortuous vessels in that region (demonstrating multi-directional flow and aliasing artifact) Subplacental hypervascularity Striking amount of color Doppler signal seen in the placental bed. This sign probably indicates numerous,closely packed, tortuous vessels in that region (demonstrating multidirectional flow and aliasing artifact)
Bridging vessels Vessels appearing to extend from the placenta across the myometrium and beyond the serosa into the bladder or other organs. Often running perpendicular to the myometrium
Placental lacunae feeder vessels Vessels with high velocity blood flow leading from the myometrium into the placental lacunae, causing turbulence upon entry
At laparotomy the following data will be reviewed(6):
Grade 1: Abnormally adherent placenta (placenta adherenta or accreta)
- Macroscopically, the uterus shows no obvious distension over the placental bed (placental "bulge"), no placental tissue is seen invading through the surface of the uterus, and there is no or minimal neovascularity Grade 2: Abnormally invasive placenta (Increta)
- Abnormal macroscopic findings over the placental bed: bluish/purple colouring, distension (placental "bulge")
- Significant amounts of hypervascularity (dense tangled bed of vessels or multiple vessels running parallel craniocaudially in the uterine serosa)
- No placental tissue seen to be invading through the uterine serosa.
- Gentle cord traction results in the uterus being pulled inwards without separation of the placenta (so-called the dimple sign) Histologic criteria
- Hysterectomy specimen or partial myometrial resection of the increta area shows placental villi within the muscular fibers and sometimes in the lumen of the deep uterine vasculature (radial or arcuate arteries) Grade 3: Abnormally invasive placenta (Percreta) Grade 3a: Limited to the uterine serosa Clinical criteria
- At laparotomy
- Abnormal macroscopic findings on uterine serosal surface (as above) and placental tissue seen to be invading through the surface of the uterus
- No invasion into any other organ, including the posterior wall of the bladder (a clear surgical plane can be identified between the bladder and uterus)
- Histologic criteria
- Hysterectomy specimen showing villous tissue within or breaching the uterine serosa Grade 3b: With urinary bladder invasion Clinical criteria
- At laparotomy
- Placental villi are seen to be invading into the bladder but no other organs
- Clear surgical plane cannot be identified between the bladder and uterus Histologic criteria
- Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading the bladder wall tissue or urothelium Grade 3c: With invasion of other pelvic tissue/organs Clinical criteria
- At laparotomy
- Placental villi are seen to be invading into the broad ligament, vaginal wall, pelvic sidewall or any other pelvic organ (with or without invasion of the bladder) Histologic criteria • Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading pelvic tissues/organs (with or without invasion of the bladder) .For the purposes of this classification, "uterus" includes the uterine body and uterine cervix .
- The data will be analysed after putting it in the following groups,
- study group consisted of patients with placenta praevia diagnosed by TVUS, control group consisted of patients undergoing elective caesarean delivery without having placenta praevia by transvaginal ultrasound (TVUS) examination
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Study group | – | –100 patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery and the current pregnancy will be complicated by placenta accreta spectrum |
| • Control group | – | –100 patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery and the current pregnancy will not be complicated by placenta accreta spectrum |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be conducted on a group of patients undergoing repeat elective cesarean delivery attending at Mansoura university hospital. - This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery
Key inclusion criteria (4 listed)
- Patients with history of previous one caesarean delivery
- Patients who refused trail of vaginal birth after caesarean section
- Patients with permanent indication for caesarean section like contracted pelvis
- Patient without any history of medical diseases
Key exclusion criteria (4 listed)
- Patients with history of more than one previous caesarean delivery
- Patients with medical disorders complicating pregnancy kike preeclampsia and gestational diabetes mellitus
- Patients with known uterine abnormalities eg (Bicornuate uterus, Adenomyosis, Submucous fibroids and Myotonic dystrophy)
- Patients who are candidates for vaginal birth after caesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum
Time frame: 1 day
association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum
1 secondary outcome
the association between parity, gravidity, place of the primary Cesarean delivery, assisted conception, and vaginal delivery before and after the primary Cesarean delivery,postpartum complications and degree of placenta accreta spectrum
Time frame: 1 week
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 22 Jan 2021.
- Background: PubMed 29405321Jauniaux E, Chantraine F, Silver RM, Langhoff-Roos J; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Epidemiology. Int J Gynaecol Obstet. 2018 Mar;140(3):265-273. doi: 10.1002/ijgo.12407. No abstract available.
- Individual participant dataSharing planned: No
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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 E Taman, MD principal investigator
Faculty of Medicine - Mansoura University
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 Mansoura University 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 4 inclusion and 4 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 22 Jan 2021. 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?
association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum (time frame: 1 day). 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 NCT04264169, which also lists 1 linked publication.
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 22 Jan 2021.