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Completed

NCT Number: NCT05208034

Medical Treatment in Ectopic Tubal Pregnancy

Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nishtar Medical University Hospital

Multan Khurd, Pu, 66000, Pakistan

About this study

Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.

A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of tubal ectopic pregnancy.
  • Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
  • Gestational sac with largest diameter as 4cm.
  • Willing to take methotrexate treatment.
  • Willing to follow up.

Exclusion criteria

  • Heterotrophic pregnancy
  • Persistent tubal pregnancy
  • Embryonic cardiac motion
  • Suspected tubal rupture
  • Past history of harmful effects of methotrexate treatment on organ functions.

Treatment and study plan

methotrexate

Drug

Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.

Primary outcomes

  1. success rate

    Time frame: 4-14 days

    In single-dose group,β-hCG levels were measured at day-4 and 7 and if β-hCG decreased >15% between day-4 and day-7, the treatment was labeled successful.

    In two-dose group, in case 15% reduction in β-hCG level was observed at day-14, the treatment was labeled as success.

Secondary outcomes

  1. frequency of Side-effects of treatment

    Time frame: 1-14 days

    monitoring for the side effects during the treatment duration

  2. β-hCG Resolution Time

    Time frame: 1-14 days

    Time taken for β-hcg resolution to reduce below 15%

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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