AzTrials
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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

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 -

  1. Day 2 blood sample for hormonal profile - follicle stimulating hormone ( FSH), estrogen (E2), progesterone (P)
  2. Blood sample for anti mullarian hormon (AMH)
  3. 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 groups in NCT02821702
Study groupRoleWhat they receive
Post surgery and embolizationExperimentalBlood 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 groupActive comparatorBlood 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 embolizationActive comparatorBlood 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 embolizationActive comparatorBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH)
Receives: Biological: Blood sample
Normal Vaginal Delivery - no suspected accretaActive comparatorBlood 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.

  1. Ovarian reserve estimated by laboratory test ( Blood sample for AMH)

    Measured: Through study completion - estimated time is six month

  2. 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.

  1. First posted1 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

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)
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 23924326
  • Eshkoli 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 23313722
  • Balayla 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 23241664
  • Clark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.

    PubMed 4011075
  • Oyelese 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 16582134
  • Vahanian 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 26428506
  • Rao 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 22926275
  • Zaki 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 9598946
  • Mohr-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

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.

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