Clinical trial

Evaluation of the Therapeutic Effect of Adding Letrozole to the Protocol of Combined Treatment of Cesarean Scar Pregnancy

Name

1072.6120.46.2021

Description

It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. There is no reference treatment of cesarean scar pregnancy (CSP) as the limited number of cases precludes the extrapolation of results. In our center we successfully use two-step treatment with methotrexate (MTX) followed by hysteroscopic removal of products of conception (POC). The time in between is needed to achieve a decrease in the trophoblast's vital potential (B-hCG fall) and its vascularization. Additional administration of letrozole could further reduce the vital potential of the pregnancy, eliminating the need for another dose of MTX, resulting in faster healing and lower rate of complications.

Trial arms

Trial start

2021-01-01

Estimated PCD

2022-12-30

Trial end

2023-10-30

Status

Completed

Treatment

MTX monotherapy

MTX in a single dose of 100 mg intravenously and 50 mg in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH), and subsequent hysteroscopic evacuation of products of conception (POC)

Arms:

MTX in monotherapy

MTX + letrozole add-on

MTX in a single dose of 100 mg intravenously and 50 mg in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH) + Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0, and subsequent hysteroscopic evacuation of products of conception (POC)

Arms:

MTX + letrozole add-on

Size

Primary endpoint

Blood loss during the procedure expressed as a decrease in hemoglobin concentration

up to 6 months

Blood loss volume during the procedure expressed in volume units

up to 6 months

Conversion rate from hysteroscopy to laparoscopy or laparotomy due to due to hemorrhage

up to 6 months

Eligibility criteria

Inclusion Criteria: * CSP confirmed on pelvic ultrasound * consent of the Bioethics Committee for termination of CSP * increasing B-hCG concentrations Exclusion Criteria: * heterotopic pregnancy * decreasing B-hCG concentrations

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

2 products

1 indication

Organization

Jagiellonian University

Product

MTX monotherapy

Indication

Cesarean Scar Pregnancy

Product

MTX + Letrozole