Medical Treatment in Ectopic Tubal Pregnancy

Nishtar Medical University (Other)
Overall Status
Completed ID

Study Details

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Actual Enrollment :
100 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
None (Open Label)
Primary Purpose:
Official Title:
Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: single-dose group

Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment).

Experimental: two-dose group

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.

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

Outcome Measures

Primary Outcome Measures

  1. success rate [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 Outcome Measures

  1. frequency of Side-effects of treatment [1-14 days]

    monitoring for the side effects during the treatment duration

  2. β-hCG Resolution Time [1-14 days]

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

Eligibility Criteria


Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Nishtar Medical University Hospital Multān Pu Pakistan 66000

Sponsors and Collaborators

  • Nishtar Medical University


  • Principal Investigator: Rashida Parveen, FCPS, Nishtar Medical University

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Rashida Parveen, Consultant Gynecologist, Nishtar Medical University Identifier:
Other Study ID Numbers:
  • NishtarMU12
First Posted:
Jan 26, 2022
Last Update Posted:
Feb 9, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2022