Scar; Previous Cesarean SectionNCT04205292
Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery
A study testing hysteroscopic in people with Scar; Previous Cesarean Section, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Scar; Previous Cesarean Section
- What is being tested?
- hysteroscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2019to 15 Jan 2022
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton gestations;
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Saccone
Naples, 80129
Gabriele Saccone, 3394685179, gabriele.saccone@libero.it
About this study
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.
Read the detailed 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.
- Conditions
- Scar; Previous Cesarean Section
- Being tested
- hysteroscopic
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopicProcedure or surgery
Women in the intervention group will receive an inpatient treatment with two-dose of Methotrexate followed by hysteroscopic resection under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Dilatation and Evacuation (D&E) | Active comparator | Women in this group will receive an in-patient treatment with Dilatation and Evacuation (D\&E) after two doses of Methotrexate . Receives: Procedure: hysteroscopic |
| hysteroscopic surgery | Experimental | Women in this group will receive hysteroscopic surgery after two doses of Methotrexate . Receives: Procedure: hysteroscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of treatment protocols,
defined as no further treatment required until the complete resolution of the scar pregnancy.
Measured: resolution of scar pregnancy, day 7
Secondary outcomes (3)
Further treatment required until the complete resolution of the scar pregnancy
Further treatment required until the complete resolution of the CSP (repeat administration of methotrexate (MTX) and/or other surgical procedures),
Measured: resolution of scar pregnancy, day 7
histerectomy
histerectomy
Measured: resolution of scar pregnancy, day 7
Maternal transfusion
Maternal transfusion
Measured: resolution of scar pregnancy, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start23 Dec 2019
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scar; Previous Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205292
- Sponsor's protocol ID
- 298-19
- Status last verified
- Oct 2020
- First submitted
- 15 Dec 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
Di Spiezio Sardo A, Zizolfi B, Saccone G, Ferrara C, Sglavo G, De Angelis MC, Mastantuoni E, Bifulco G. Hysteroscopic resection vs ultrasound-guided dilation and evacuation for treatment of cesarean scar ectopic pregnancy: a randomized clinical trial. Am J Obstet Gynecol. 2023 Oct;229(4):437.e1-437.e7. doi: 10.1016/j.ajog.2023.04.038. Epub 2023 May 3.
PubMed 37142075
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery
- ClinicalTrials.gov ID
- NCT04205292
- Acronym / sponsor ID
- 298-19
- Conditions
- Scar; Previous Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 19 Dec 2019 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilatation and Evacuation (D&E) | Active comparator | Procedure: hysteroscopicWomen in this group will receive an in-patient treatment with Dilatation and Evacuation (D\&E) after two doses of Methotrexate . |
| hysteroscopic surgery | Experimental | Procedure: hysteroscopicWomen in this group will receive hysteroscopic surgery after two doses of Methotrexate . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton gestations;
- 18 years to 50 years;
- Diagnosis of CSP;
- Gestational age ≤ 8 weeks and 6 days;
- Therapy with systemic Methotrexate 2-dose;
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| hysteroscopicWomen in the intervention group will receive an inpatient treatment with two-dose of Methotrexate followed by hysteroscopic resection under ultrasound guidance | Procedure or surgery | Dilatation and Evacuation (D&E), hysteroscopic surgery |
Primary outcome
success rate of treatment protocols,
Time frame: resolution of scar pregnancy, day 7
defined as no further treatment required until the complete resolution of the scar pregnancy.
3 secondary outcomes
Further treatment required until the complete resolution of the scar pregnancy
Time frame: resolution of scar pregnancy, day 7
histerectomy
Time frame: resolution of scar pregnancy, day 7
Maternal transfusion
Time frame: resolution of scar pregnancy, day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 37142075Di Spiezio Sardo A, Zizolfi B, Saccone G, Ferrara C, Sglavo G, De Angelis MC, Mastantuoni E, Bifulco G. Hysteroscopic resection vs ultrasound-guided dilation and evacuation for treatment of cesarean scar ectopic pregnancy: a randomized clinical trial. Am J Obstet Gynecol. 2023 Oct;229(4):437.e1-437.e7. doi: 10.1016/j.ajog.2023.04.038. Epub 2023 May 3.
- Individual participant dataSharing planned: No. no plan
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscopic in people with Scar; Previous Cesarean Section, run by Federico II University at 1 site in Italy.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Oct 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Saccone, MD (0817461111, gabriele.saccone@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of treatment protocols, (time frame: resolution of scar pregnancy, day 7). 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 NCT04205292, which also lists 1 linked publication.
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 8 Oct 2020.