Medical Treatment in Ectopic Tubal Pregnancy

NCT05208034 | Completed

• 1 other identifier: NishtarMU12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  4-14 days

Secondary Outcomes (2)

• frequency of Side-effects of treatment

  1-14 days

• β-hCG Resolution Time

  1-14 days

Study Arms (2)

single-dose group

NO INTERVENTION

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

two-dose group

EXPERIMENTAL

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

Interventions

Methotrexate DRUG

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

two-dose group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University Hospital

Multan Khurd, Pu, 66000, Pakistan

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rashida Parveen, FCPS

  Nishtar Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gynecologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: January 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)