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Letrozole add-on in the Treatment of Cesarean Scar Pregnancy

Sponsor
Jagiellonian University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05839574
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
29.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MTX monotherapy
  • Drug: MTX + letrozole add-on
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Therapeutic Effect of Adding Letrozole to the Protocol of Combined Treatment of Cesarean Scar Pregnancy
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: MTX in monotherapy

Combined treatment with MTX followed by hysteroscopic evacuation of POC

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)
Active Comparator: MTX + letrozole add-on

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

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)

Outcome Measures

Primary Outcome Measures

  1. Blood loss during the procedure expressed as a decrease in hemoglobin concentration [up to 6 months]

    Decrease in hemoglobin concentration in g/dl on day 1 after the procedure compared to the pre-procedure concentration

  2. Blood loss volume during the procedure expressed in volume units [up to 6 months]

    The volume of blood lost during the procedure in ml

  3. Conversion rate from hysteroscopy to laparoscopy or laparotomy due to due to hemorrhage [up to 6 months]

    Percentage (%) of conversion from hysteroscopy to laparoscopy or laparotomy due to hemorrhage

Secondary Outcome Measures

  1. The effect of treatment on bone marrow function (red blood cells) [up to 6 months]

    Change in red blood count (T/l) in the course of treatment (day 0,4,7)

  2. The effect of treatment on bone marrow function (white blood cells) [up to 6 months]

    Change in white blood count (G/l) in the course of treatment (day 0,4,7)

  3. The effect of treatment on bone marrow function (platelets) [up to 6 months]

    Change in platelet count (G/l) in the course of treatment (day 0,4,7)

  4. The effect of treatment on liver function (serum total bilirubin) [up to 6 months]

    Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)

  5. The effect of treatment on liver function (alanine transaminase) [up to 6 months]

    Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)

  6. The effect of treatment on liver function (aspartate transaminase) [up to 6 months]

    Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)

  7. The effect of treatment on liver function (gamma-glutamyltransferase) [up to 6 months]

    Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)

  8. The effect of treatment on kidneys function (urea) [up to 6 months]

    Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)

  9. The effect of treatment on kidneys function (creatinine) [up to 6 months]

    Changes in the concentrations of serum and creatinine (mg/dl) in the course of treatment (day 0,4,7)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology Krakow Poland 31-501

Sponsors and Collaborators

  • Jagiellonian University

Investigators

  • Principal Investigator: Iwona M. Gawron, M.D., Ph.D., Jagiellonian University
  • Study Chair: Robert Jach, Prof., Ph.D., Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iwona Magdalena Gawron, M.D., Ph.D., Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT05839574
Other Study ID Numbers:
  • 1072.6120.46.2021
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Iwona Magdalena Gawron, M.D., Ph.D., Principal Investigator, Jagiellonian University
cesarean scar pregnancy
operative hysteroscopy
Additional relevant MeSH terms:
Cicatrix
Letrozole

Study Results

No Results Posted as of May 3, 2023