Medical Treatment in Ectopic Tubal Pregnancy
Primary Purpose
Ectopic Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Ectopic Pregnancy
Eligibility Criteria
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.
Sites / Locations
- Nishtar Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
single-dose group
two-dose group
Arm Description
Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment).
Women allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14.
Outcomes
Primary Outcome Measures
success rate
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 Outcome Measures
frequency of Side-effects of treatment
monitoring for the side effects during the treatment duration
β-hCG Resolution Time
Time taken for β-hcg resolution to reduce below 15%
Full Information
NCT ID
NCT05208034
First Posted
January 12, 2022
Last Updated
January 25, 2022
Sponsor
Nishtar Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05208034
Brief Title
Medical Treatment in Ectopic Tubal Pregnancy
Official Title
Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nishtar Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-dose group
Arm Type
No Intervention
Arm Description
Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment).
Arm Title
two-dose group
Arm Type
Experimental
Arm Description
Women allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.
Primary Outcome Measure Information:
Title
success rate
Description
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.
Time Frame
4-14 days
Secondary Outcome Measure Information:
Title
frequency of Side-effects of treatment
Description
monitoring for the side effects during the treatment duration
Time Frame
1-14 days
Title
β-hCG Resolution Time
Description
Time taken for β-hcg resolution to reduce below 15%
Time Frame
1-14 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashida Parveen, FCPS
Organizational Affiliation
Nishtar Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nishtar Medical University Hospital
City
Multān
State/Province
Pu
ZIP/Postal Code
66000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Medical Treatment in Ectopic Tubal Pregnancy
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