Status:

UNKNOWN

Letrozole in Tubal Ectopic Pregnancy

Lead Sponsor:

Queen Mary Hospital, Hong Kong

Collaborating Sponsors:

Kwong Wah Hospital

Princess Margaret Hospital, Hong Kong

Conditions:

Tubal Pregnancy

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

This is a multi-centred randomized controlled trial on the addition of letrozole in the medical management of tubal ectopic pregnancies. Tubal ectopic pregnancies are abnormal pregnancies in the Fall...

Detailed Description

Tubal ectopic pregnancies occur in around 1-2% of all pregnancies. Traditionally, surgery with salpingectomy was the mainstay of treatment; however, it comes with anaesthetic and operatives risks in a...

Eligibility Criteria

Inclusion

  • Presence of heterogenous adnexal mass on USG suggestive of tubal ectopic pregnancy with hCG level \>=1500 IU/L and \<= 5000 IU/L
  • Absence of fetal heart pulsation
  • Mean diameter of adnexal mass \<= 3.5cm
  • Haemodynamically stable
  • No significant abdominal pain

Exclusion

  • Presence of significant amount of free fluid in pelvis
  • Allergic to MTX
  • Deranged liver function test (AST/ ALT or GGT \>= 2 upper limit of normal)
  • Deranged renal function test (eGFR \<= 45ml/min)
  • Heterotopic pregnancies

Key Trial Info

Start Date :

December 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2025

Estimated Enrollment :

214 Patients enrolled

Trial Details

Trial ID

NCT04341545

Start Date

December 1 2020

End Date

March 31 2025

Last Update

April 10 2023

Active Locations (1)

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1

Department of Obstetrics and Gynaecology, Queen Mary Hospital

Hong Kong, Hong Kong