Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery

  • STATUS
    Recruiting
  • End date
    Jan 15, 2022
  • participants needed
    54
  • sponsor
    Federico II University
Updated on 26 January 2021

Summary

Cesarean scar pregnancy (CSP) is a relative "new" type of ectopic pregnancy where the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean section.

A recent review amounts almost 31 different treatment modalities for CSP. A broad spectrum of options represents a real challenge for the health care provider. The choice may be made among expectant management, medical treatment, local treatment and surgical approach, also combined together. There is insufficient evidence to recommend any one specific intervention over another for caesarean scar pregnancy. Future studies are needed to define the optimal management of pregnancy for caesarean section scars.

Thus, we aim to compare the success rate of two different treatment of CSP: the medical management by using two-dose of Methotrexate (MTX) followed by dilation and evacuation (D&E) compared to single dose of two-dose of Methotrexate followed by hysperoscopic approach.

Description

Cesarean scar pregnancy (CSP) is a relative "new" type of ectopic pregnancy where the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean section. Since the first description of cesarean scar pregnancy in 1978, its frequency has increased dramatically due to the significant increase in the percentage of cesarean section and development of transvaginal (TV) ultrasonography (US). The overall incidence of CSP is 1 in 1,800 to 1 in 2,200 pregnancies, it means 0.05-0.04% of all pregnancies. In women after a cesarean section, the frequency of CSP is approximately 0.15%, which constitutes 6.1% of all ectopic pregnancies in patients after at least one cesarean operation. The risk factors that favour implantation in the CS scar are not well understood; therefore, there are no guidelines for the practicing physicians to determine the women at risk. Uterine surgery, anomalous healing of the scar, previous preterm CS without labour or a term elective CS, breech presentation at previous CS short intervals between the CSP and last pregnancy, last pregnancy ended with abortion may be some of the risk factors for CSP.

Although the 15% of CSPs remain undiagnosed, developed egographic techniques and several new US signs of CSP invasiveness are allowing ever better diagnoses. Cali et al. tested the hypothesis the relationship between the gestational sac of the CSP, previous caesarean scar and the anterior uterine wall can be used to predict the evolution of these cases. In order to do this, they propose a new sonographic sign, the "cross-over sign" (COS) . This echographic sign is reflected in the clinical presentation of the CSP, so we can divide the patients into two different groups: type I "endogenic type" characterized by the COS2 insertion, ance type II "exogenic type" characterized by COS1 insertion, the latter with worse outcomes in term of maternal morbidity and mortality.

A recent review amounts almost 31 different treatment modalities for CSP. A broad spectrum of options represents a real challenge for the health care provider. The choice may be made among expectant management, medical treatment, local treatment and surgical approach, also combined together. There is insufficient evidence to recommend any one specific intervention over another for caesarean scar pregnancy. Future studies are needed to define the optimal management of pregnancy for caesarean section scars.

Thus, we aim to compare the success rate of two different treatment of CSP: the medical management by using two-dose of Methotrexate (MTX) followed by dilation and evacuation (D&E) compared to single dose of two-dose of Methotrexate followed by hysperoscopic approach.

Details
Condition Scar; Previous Cesarean Section, Scar; Previous Cesarean Section, Scar; Previous Cesarean Section, Scar; Previous Cesarean Section, Scar; Previous Cesarean Section
Treatment Hysteroscopic
Clinical Study IdentifierNCT04205292
SponsorFederico II University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Singleton gestations
years to 50 years
Diagnosis of CSP
Gestational age 8 weeks and 6 days
Therapy with systemic Methotrexate 2-dose
Thickness of myometrial layer 2 mm

Exclusion Criteria

Diagnosis of cervical pregnancy, aborting intrauterine pregnancy, or any other anomalous implantation site
Gestational age >8 weeks and 6 days
Heavy vaginal bleeding at the time of randomization
Women who did not received Methotrexate or received a single dose or a local dose
Thickness of myometrial layer <2 mm
Women who are unconscious, ill, mentally handicapped
Women under the age of 18 years or over the age of 50 years
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note