Letrozole add-on in the Treatment of Cesarean Scar Pregnancy

Cesarean Scar Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839574
• Other study ID #: 1072.6120.46.2021
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Scar Pregnancy
• Cicatrix

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss during the procedure expressed as a decrease in hemoglobin concentration	Decrease in hemoglobin concentration in g/dl on day 1 after the procedure compared to the pre-procedure concentration	up to 6 months
Primary	Blood loss volume during the procedure expressed in volume units	The volume of blood lost during the procedure in ml	up to 6 months
Primary	Conversion rate from hysteroscopy to laparoscopy or laparotomy due to due to hemorrhage	Percentage (%) of conversion from hysteroscopy to laparoscopy or laparotomy due to hemorrhage	up to 6 months
Secondary	The effect of treatment on bone marrow function (red blood cells)	Change in red blood count (T/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on bone marrow function (white blood cells)	Change in white blood count (G/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on bone marrow function (platelets)	Change in platelet count (G/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on liver function (serum total bilirubin)	Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on liver function (alanine transaminase)	Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on liver function (aspartate transaminase)	Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on liver function (gamma-glutamyltransferase)	Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on kidneys function (urea)	Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)	up to 6 months
Secondary	The effect of treatment on kidneys function (creatinine)	Changes in the concentrations of serum and creatinine (mg/dl) in the course of treatment (day 0,4,7)	up to 6 months