Medical Treatment in Ectopic Tubal Pregnancy

Ectopic Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208034
• Other study ID #: NishtarMU12
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2022
• Source: Nishtar Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Diagnosis of tubal ectopic pregnancy.
• Pre-treatment beta-human chorionic gonadotrophin (ß-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.

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

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

Locations

Country	Name	City	State
Pakistan	Nishtar Medical University Hospital	Multan	Pu

Sponsors (1)

Lead Sponsor	Collaborator
Nishtar Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	In single-dose group,ß-hCG levels were measured at day-4 and 7 and if ß-hCG decreased >15% between day-4 and day-7, the treatment was labeled successful.; In two-dose group, in case 15% reduction in ß-hCG level was observed at day-14, the treatment was labeled as success.	4-14 days
Secondary	frequency of Side-effects of treatment	monitoring for the side effects during the treatment duration	1-14 days
Secondary	ß-hCG Resolution Time	Time taken for ß-hcg resolution to reduce below 15%	1-14 days