Letrozole add-on in the Treatment of Cesarean Scar Pregnancy

NCT ID: NCT05839574

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-10-30

Brief Summary

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.

Detailed Description

A prospective cohort study is conducted among women with cesarean scar pregnancy (CSP). Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.

Two study arms were planned:

• women treated with a single dose of 100 mg MTX intravenously and 50 mg MTX in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH)
• women treated with a single dose of 100 mg MTX intravenously and 50 mg MTX in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH) with additional use of letrozole 5 mg orally (from day 0) for 10 days.

Blood parameters (B-hCG, hemoglobin, total blood count, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7, followed by B-hCG concentration measurement every 7 days until surgery. After obtaining satisfactory decrease in B-hCG and POC vascularization, women underwent hysteroscopic evacuation of POC. Blood loss parameters, frequency of conversion from hysteroscopy to laparoscopy and laparotomy were measured.

The women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.

Conditions

Cesarean Scar Pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MTX in monotherapy

Combined treatment with MTX followed by hysteroscopic evacuation of POC

Group Type: ACTIVE_COMPARATOR

MTX monotherapy

Intervention Type: DRUG

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)

MTX + letrozole add-on

Combined treatment with MTX + letrozole add-on followed by hysteroscopic evacuation of POC

Group Type: ACTIVE_COMPARATOR

MTX + letrozole add-on

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Iwona Magdalena Gawron

M.D., Ph.D., Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iwona M. Gawron, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Robert Jach, Prof., Ph.D.

Role: STUDY_CHAIR

Jagiellonian University

Locations

Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology

Krakow, , Poland

Countries

Poland

Other Identifiers

1072.6120.46.2021

Identifier Type: -

Identifier Source: org_study_id