Fertility Post Placenta Accrete
CSAC
Fertility Post Preservative Cesarean Section and Uterine Artery Embolization
1 other identifier
interventional
135
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 9, 2020
April 1, 2020
3.4 years
June 17, 2016
April 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ovarian reserve estimated by laboratory test ( Blood sample for AMH)
Through study completion - estimated time is six month
Ovarian reserve estimated by ultrasound evaluation (AFC)
Through study completion - estimated time is six month
Study Arms (5)
Post surgery and embolization
EXPERIMENTALBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC)
Control group
ACTIVE COMPARATORBlood 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 COMPARATORBlood 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 COMPARATORBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH)
Normal Vaginal Delivery - no suspected accreta
ACTIVE COMPARATORBlood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age \>42
- Hysterectomy due to the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
Related Publications (9)
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.
PMID: 23924326BACKGROUNDEshkoli 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.
PMID: 23313722BACKGROUNDBalayla 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.
PMID: 23241664BACKGROUNDClark SL, Koonings PP, Phelan JP. Placenta previa/accreta and prior cesarean section. Obstet Gynecol. 1985 Jul;66(1):89-92.
PMID: 4011075BACKGROUNDOyelese 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.
PMID: 16582134BACKGROUNDVahanian 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.
PMID: 26428506BACKGROUNDRao 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.
PMID: 22926275BACKGROUNDZaki 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.
PMID: 9598946BACKGROUNDMohr-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.
PMID: 34472035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aya Mohr Sasson
Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 17, 2016
First Posted
July 1, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share