FertilityCSACNCT02821702
Fertility Post Placenta Accrete
A study testing Vaginal ultrasound and Blood sample in people with Fertility, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study is the first to investigate the fertility outcome and the influence on ovarian reserve after using uterine artery embolization during cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Vaginal ultrasound and Blood sample
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to Dec 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study group
- S/P cesarean section with bilateral uterine arteries embolization.
- Age 18-42
- Control group ( from IVF clinic)
- infertility treatment due to male factor
- Single patients for sperm donation
- Age 18-42
Who cannot join
- Age >42
- Hysterectomy due to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fertility Post Preservative Cesarean Section and Uterine Artery Embolization
This study is the first to investigate the fertility outcome and the influence on ovarian reserve after using uterine artery embolization during cesarean delivery.
Read the detailed description
Placenta accreta is an abnormal adherence of the placenta to the uterine wall. Three variants of abnormally invasive placentation have been described: placenta accreta, in which placental villi invade the surface of the myometrium; placenta increta, in which placental villi extend into the myometrium; and placenta percreta, where the villi penetrate through the myometrium to the uterine serosa and may invade adjacent organs, such as the bladder.
Placenta accrete is an increasingly prevalent and potentially dangerous complication of pregnancy. It appears to be most strongly predicted by a history of cesarean deliveries and low-lying placenta/previa. Additional risk factors include in vitro fertilization pregnancy, prior myomectomy, Asherman's syndrome, submucous leiomyomata, maternal age older than 35 years, elevated second-trimester levels of α-fetoprotein and β-human chorionic gonadotropin.
Pregnancies complicated with placenta accrete are associated with adverse maternal outcomes, including life-threatening maternal haemorrhage, large-volume blood transfusion, uterine rupture and peripartum hysterectomy. Moreover , strong association was found between abnormal placentation to significant perinatal morbidity and mortality such as small for gestational age, preterm delivery, neonatal intensive care unit hospitalization, perinatal death and neonatal death.
Prenatal diagnosis and adequate planning, particularly in high-risk populations, is indicated for the reduction of these adverse outcomes. Advances in grayscale and Doppler ultrasound have facilitated prenatal diagnosis. Despite advances in imaging techniques, no diagnostic technique affords the clinician complete assurance of the presence or absence of placenta accreta.
Management of placenta accrete could be conservative (aiming for uterine preservation) or interventional ( elective cesarean hysterectomy ) depending on the patients will to maintain the uterus for future fertility, the degree of placentation abnormality or complications during delivery. The extent (area, depth) of the abnormal attachment will determine the response-curettage, wedge resection, medical management, or hysterectomy. Uterine conserving options may work in small focal accretas, but abdominal hysterectomy usually is the most definitive treatment.
Post-partum hemorrhage is the major concern dealing with placenta accrete. Women with placenta accreta have a higher incidence of postpartum hemorrhage and are more likely to undergo emergency hysterectomy .
If the diagnosis or a strong suspicion is formed before delivery, a number of measures should be taken including counseling the patient about the likelihood of hysterectomy and blood transfusion, preparing blood products and clotting factors and considering using cell saver technology.The appropriate location and timing for delivery should be considered to allow access to adequate surgical personnel and equipment and a preoperative anesthesia assessment should be obtained.
A patient with stable vital signs and persistent bleeding, especially if the rate of loss is not excessive, may be a candidate for arterial embolization. Radiographic identification of bleeding vessels allows embolization with gelfoam, coils, or glue. Balloon occlusion is also a technique used in such circumstances. Embolization can be used for bleeding that continues after hysterectomy or can be used as an alternative to hysterectomy to preserve fertility.
Studies estimating the fertility and pregnancy outcomes after successful conservative treatment for placenta accrete have demonstrated placenta accreta does not appear to compromise the patients' subsequent fertility or obstetrical outcome.
By reviewing the literature, no prospective studies have specifically evaluated fertility, following uterine artery embolization during cesarean section due to placenta accrete .
Methods:
Women that were operated and fit inclusion criteria will be invited to participate in the study after getting advanced notice on requirements . After giving informed consent to participate in the study, demographic parameters and medical history will be taken, including - age , Body Mass Index ( BMI), parity, gravity, past medical history, past operations.
preoperative intra operative and post operative information will be collected.
All women participating will complete -
- Day 2 blood sample for hormonal profile - follicle stimulating hormone ( FSH), estrogen (E2), progesterone (P)
- Blood sample for anti mullarian hormon (AMH)
- Vaginal ultrasound assessing antral follicle count (AFC)
- Conditions
- Fertility
- Being tested
- Vaginal ultrasound, Blood sample
- Keywords
- placenta accreta, cesarean section, artery embolization
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal ultrasoundDevice
Blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Post surgery and embolization | Experimental | Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC) Receives: Device: Vaginal ultrasound; Biological: Blood sample |
| Control group | Active comparator | Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC) Receives: Device: Vaginal ultrasound; Biological: Blood sample |
| Post surgery with accreta without embolization | Active comparator | Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC) Receives: Device: Vaginal ultrasound; Biological: Blood sample |
| Post surgery without accreta without embolization | Active comparator | Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Receives: Biological: Blood sample |
| Normal Vaginal Delivery - no suspected accreta | Active comparator | Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve estimated by laboratory test ( Blood sample for AMH)
Measured: Through study completion - estimated time is six month
Ovarian reserve estimated by ultrasound evaluation (AFC)
Measured: Through study completion - estimated time is six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Aya Mohr Sasson, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821702
- Sponsor's protocol ID
- 3178-16- SMC
- Acronym
- CSAC
- Status last verified
- Apr 2020
- First submitted
- 17 Jun 2016
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fitzpatrick KE, Sellers S, Spark P, Kurinczuk JJ, Brocklehurst P, Knight M. The management and outcomes of placenta accreta, increta, and percreta in the UK: a population-based descriptive study. BJOG. 2014 Jan;121(1):62-70; discussion 70-1. doi: 10.1111/1471-0528.12405. Epub 2013 Aug 7.
PubMed 23924326Eshkoli T, Weintraub AY, Sergienko R, Sheiner E. Placenta accreta: risk factors, perinatal outcomes, and consequences for subsequent births. Am J Obstet Gynecol. 2013 Mar;208(3):219.e1-7. doi: 10.1016/j.ajog.2012.12.037. Epub 2013 Jan 8.
PubMed 23313722Balayla J, Bondarenko HD. Placenta accreta and the risk of adverse maternal and neonatal outcomes. J Perinat Med. 2013 Mar;41(2):141-9. doi: 10.1515/jpm-2012-0219.
PubMed 23241664Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.
PubMed 4011075Oyelese Y, Smulian JC. Placenta previa, placenta accreta, and vasa previa. Obstet Gynecol. 2006 Apr;107(4):927-41. doi: 10.1097/01.AOG.0000207559.15715.98.
PubMed 16582134Vahanian SA, Lavery JA, Ananth CV, Vintzileos A. Placental implantation abnormalities and risk of preterm delivery: a systematic review and metaanalysis. Am J Obstet Gynecol. 2015 Oct;213(4 Suppl):S78-90. doi: 10.1016/j.ajog.2015.05.058.
PubMed 26428506Rao KP, Belogolovkin V, Yankowitz J, Spinnato JA 2nd. Abnormal placentation: evidence-based diagnosis and management of placenta previa, placenta accreta, and vasa previa. Obstet Gynecol Surv. 2012 Aug;67(8):503-19. doi: 10.1097/OGX.0b013e3182685870.
PubMed 22926275Zaki ZM, Bahar AM, Ali ME, Albar HA, Gerais MA. Risk factors and morbidity in patients with placenta previa accreta compared to placenta previa non-accreta. Acta Obstet Gynecol Scand. 1998 Apr;77(4):391-4.
PubMed 9598946Mohr-Sasson A, Haas J, Bar-Adon S, Shats M, Hochman R, Orvieto R, Mazaki-Tovi S, Sivan E. The Influence of Cesarean Delivery on Ovarian Reserve: a Prospective Cohort Study. Reprod Sci. 2022 Feb;29(2):639-645. doi: 10.1007/s43032-021-00730-z. Epub 2021 Sep 1.
PubMed 34472035
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Post Preservative Cesarean Section and Uterine Artery Embolization
- ClinicalTrials.gov ID
- NCT02821702
- Acronym / sponsor ID
- CSAC / 3178-16- SMC
- Conditions
- Fertility
- Keywords
- placenta accreta, cesarean section, artery embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Jul 2016 (estimated)
- 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 is the first to investigate the fertility outcome and the influence on ovarian reserve after using uterine artery embolization during cesarean delivery.
Detailed description
Placenta accreta is an abnormal adherence of the placenta to the uterine wall. Three variants of abnormally invasive placentation have been described: placenta accreta, in which placental villi invade the surface of the myometrium; placenta increta, in which placental villi extend into the myometrium; and placenta percreta, where the villi penetrate through the myometrium to the uterine serosa and may invade adjacent organs, such as the bladder.
Placenta accrete is an increasingly prevalent and potentially dangerous complication of pregnancy. It appears to be most strongly predicted by a history of cesarean deliveries and low-lying placenta/previa. Additional risk factors include in vitro fertilization pregnancy, prior myomectomy, Asherman's syndrome, submucous leiomyomata, maternal age older than 35 years, elevated second-trimester levels of α-fetoprotein and β-human chorionic gonadotropin.
Pregnancies complicated with placenta accrete are associated with adverse maternal outcomes, including life-threatening maternal haemorrhage, large-volume blood transfusion, uterine rupture and peripartum hysterectomy. Moreover , strong association was found between abnormal placentation to significant perinatal morbidity and mortality such as small for gestational age, preterm delivery, neonatal intensive care unit hospitalization, perinatal death and neonatal death.
Prenatal diagnosis and adequate planning, particularly in high-risk populations, is indicated for the reduction of these adverse outcomes. Advances in grayscale and Doppler ultrasound have facilitated prenatal diagnosis. Despite advances in imaging techniques, no diagnostic technique affords the clinician complete assurance of the presence or absence of placenta accreta.
Management of placenta accrete could be conservative (aiming for uterine preservation) or interventional ( elective cesarean hysterectomy ) depending on the patients will to maintain the uterus for future fertility, the degree of placentation abnormality or complications during delivery. The extent (area, depth) of the abnormal attachment will determine the response-curettage, wedge resection, medical management, or hysterectomy. Uterine conserving options may work in small focal accretas, but abdominal hysterectomy usually is the most definitive treatment.
Post-partum hemorrhage is the major concern dealing with placenta accrete. Women with placenta accreta have a higher incidence of postpartum hemorrhage and are more likely to undergo emergency hysterectomy .
If the diagnosis or a strong suspicion is formed before delivery, a number of measures should be taken including counseling the patient about the likelihood of hysterectomy and blood transfusion, preparing blood products and clotting factors and considering using cell saver technology.The appropriate location and timing for delivery should be considered to allow access to adequate surgical personnel and equipment and a preoperative anesthesia assessment should be obtained.
A patient with stable vital signs and persistent bleeding, especially if the rate of loss is not excessive, may be a candidate for arterial embolization. Radiographic identification of bleeding vessels allows embolization with gelfoam, coils, or glue. Balloon occlusion is also a technique used in such circumstances. Embolization can be used for bleeding that continues after hysterectomy or can be used as an alternative to hysterectomy to preserve fertility.
Studies estimating the fertility and pregnancy outcomes after successful conservative treatment for placenta accrete have demonstrated placenta accreta does not appear to compromise the patients' subsequent fertility or obstetrical outcome.
By reviewing the literature, no prospective studies have specifically evaluated fertility, following uterine artery embolization during cesarean section due to placenta accrete .
Methods:
Women that were operated and fit inclusion criteria will be invited to participate in the study after getting advanced notice on requirements . After giving informed consent to participate in the study, demographic parameters and medical history will be taken, including - age , Body Mass Index ( BMI), parity, gravity, past medical history, past operations.
preoperative intra operative and post operative information will be collected.
All women participating will complete -
- Day 2 blood sample for hormonal profile - follicle stimulating hormone ( FSH), estrogen (E2), progesterone (P)
- Blood sample for anti mullarian hormon (AMH)
- Vaginal ultrasound assessing antral follicle count (AFC)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Post surgery and embolization | Experimental | Device: Vaginal ultrasound, Biological: Blood sampleBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC) |
| Control group | Active comparator | Device: Vaginal ultrasound, Biological: Blood sampleBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC) |
| Post surgery with accreta without embolization | Active comparator | Device: Vaginal ultrasound, Biological: Blood sampleBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC) |
| Post surgery without accreta without embolization | Active comparator | Biological: Blood sampleBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) |
| Normal Vaginal Delivery - no suspected accreta | Active comparator | Biological: Blood sampleBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Study group
- S/P cesarean section with bilateral uterine arteries embolization.
- Age 18-42
- Control group ( from IVF clinic)
- infertility treatment due to male factor
Key exclusion criteria (2 listed)
- Age >42
- Hysterectomy due to the procedure
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 |
|---|---|---|
| Vaginal ultrasound | Device | Control group, Post surgery and embolization, Post surgery with accreta without embolization |
| Blood sample | Biological | Control group, Normal Vaginal Delivery - no suspected accreta, Post surgery and embolization, Post surgery with accreta without embolization, Post surgery without accreta without embolization |
Primary outcome
Ovarian reserve estimated by laboratory test ( Blood sample for AMH)
Time frame: Through study completion - estimated time is six month
Ovarian reserve estimated by ultrasound evaluation (AFC)
Time frame: Through study completion - estimated time is six month
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 9 Apr 2020.
- Background: PubMed 23924326Fitzpatrick KE, Sellers S, Spark P, Kurinczuk JJ, Brocklehurst P, Knight M. The management and outcomes of placenta accreta, increta, and percreta in the UK: a population-based descriptive study. BJOG. 2014 Jan;121(1):62-70; discussion 70-1. doi: 10.1111/1471-0528.12405. Epub 2013 Aug 7.
- Background: PubMed 23313722Eshkoli T, Weintraub AY, Sergienko R, Sheiner E. Placenta accreta: risk factors, perinatal outcomes, and consequences for subsequent births. Am J Obstet Gynecol. 2013 Mar;208(3):219.e1-7. doi: 10.1016/j.ajog.2012.12.037. Epub 2013 Jan 8.
- Background: PubMed 23241664Balayla J, Bondarenko HD. Placenta accreta and the risk of adverse maternal and neonatal outcomes. J Perinat Med. 2013 Mar;41(2):141-9. doi: 10.1515/jpm-2012-0219.
- Background: PubMed 4011075Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.
- Background: PubMed 16582134Oyelese Y, Smulian JC. Placenta previa, placenta accreta, and vasa previa. Obstet Gynecol. 2006 Apr;107(4):927-41. doi: 10.1097/01.AOG.0000207559.15715.98.
- Background: PubMed 26428506Vahanian SA, Lavery JA, Ananth CV, Vintzileos A. Placental implantation abnormalities and risk of preterm delivery: a systematic review and metaanalysis. Am J Obstet Gynecol. 2015 Oct;213(4 Suppl):S78-90. doi: 10.1016/j.ajog.2015.05.058.
- Background: PubMed 22926275Rao KP, Belogolovkin V, Yankowitz J, Spinnato JA 2nd. Abnormal placentation: evidence-based diagnosis and management of placenta previa, placenta accreta, and vasa previa. Obstet Gynecol Surv. 2012 Aug;67(8):503-19. doi: 10.1097/OGX.0b013e3182685870.
- Background: PubMed 9598946Zaki ZM, Bahar AM, Ali ME, Albar HA, Gerais MA. Risk factors and morbidity in patients with placenta previa accreta compared to placenta previa non-accreta. Acta Obstet Gynecol Scand. 1998 Apr;77(4):391-4.
- Derived from this study: PubMed 34472035Mohr-Sasson A, Haas J, Bar-Adon S, Shats M, Hochman R, Orvieto R, Mazaki-Tovi S, Sivan E. The Influence of Cesarean Delivery on Ovarian Reserve: a Prospective Cohort Study. Reprod Sci. 2022 Feb;29(2):639-645. doi: 10.1007/s43032-021-00730-z. Epub 2021 Sep 1.
- 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.
Aya Mohr Sasson principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal ultrasound and Blood sample in people with Fertility, run by Sheba Medical Center at 1 site in Israel.
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 7 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 9 Apr 2020. 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 Israel. 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?
Ovarian reserve estimated by laboratory test ( Blood sample for AMH) (time frame: Through study completion - estimated time is six month). 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?
On the ClinicalTrials.gov record for NCT02821702, which also lists 9 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 9 Apr 2020.