Fertility Post Placenta Accrete (CSAC)

April 7, 2020 updated by: Dr. Aya Mohr-Sasson, Sheba Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age >42
  • Hysterectomy due to the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post surgery and embolization
Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC)
Biological: Blood sample
Device: Vaginal ultrasound
Active Comparator: Control group
Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC)
Biological: Blood sample
Device: Vaginal ultrasound
Active Comparator: Post surgery with accreta without embolization
Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH) Vaginal ultrasound to estimate antral follicle count ( AFC)
Biological: Blood sample
Device: Vaginal ultrasound
Active Comparator: Post surgery without accreta without embolization
Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH)
Biological: Blood sample
Active Comparator: Normal Vaginal Delivery - no suspected accreta
Blood sample for hormonal profile: estrogen , progesterone, anti mullarian hormone ( AMH)
Biological: Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovarian reserve estimated by laboratory test ( Blood sample for AMH)
Time Frame: Through study completion - estimated time is six month
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
Through study completion - estimated time is six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Aya Mohr Sasson, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3178-16- SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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