| CTRI Number |
CTRI/2025/12/098379 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the effectiveness and side effects of Methotrexate in unruptured tubal ectopic pregnancy |
|
Scientific Title of Study
|
A study to evaluate the efficacy, safety and pharmacokinetics of Methotrexate in unruptured tubal ectopic pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lekha Saha |
| Designation |
Professor Department of Pharmacology |
| Affiliation |
PGIMER Chandigarh |
| Address |
Dr Lekha Saha Room no. 4014
Department of Pharmacology
PN Chuttani block
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503752 |
| Fax |
|
| Email |
lekhasaha@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lekha Saha |
| Designation |
Professor Department of Pharmacology |
| Affiliation |
PGIMER Chandigarh |
| Address |
Dr Lekha Saha Room no. 4014
Department of Pharmacology
PN Chuttani block
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503752 |
| Fax |
|
| Email |
lekhasaha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lekha Saha |
| Designation |
Professor Department of Pharmacology |
| Affiliation |
PGIMER Chandigarh |
| Address |
Dr Lekha Saha Room no. 4014
Department of Pharmacology
PN Chuttani block
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463503752 |
| Fax |
|
| Email |
lekhasaha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER Sector 12
Chandigarh, India 160012 |
|
|
Primary Sponsor
|
| Name |
Department Of Pharmacology |
| Address |
Department Of Pharmacology, PGIMER Chandigarh
Sector 12 Chandigarh India 160012
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lekha Saha |
PGIMER |
Room No. 4014
Department of Pharmacology Research Block B
Sector 12 Chandigarh India
160012
Chandigarh
CHANDIGARH |
9463503752
lekhasaha@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O001||Tubal pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Treatment naïve unruptured tubal ectopic pregnancy.
2.Hemodynamically stable patient
3.No contraindications to Methotrexate.
4.Willingness to give informed written consent.
|
|
| ExclusionCriteria |
| Details |
1.Ruptured ectopic pregnancy
2.Signs of hemodynamic instability.
3.Contraindication to methotrexate
4.Pre-existing hepatic/renal dysfunction, immunodeficiency, or hypersensitivity to MTX
5.Patient who has already received methotrexate from outside
6.Patient who are not willing to give consent for the study.
7.Chronic ectopic pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of efficacy of methotrexate in the management of unruptured tubal ectopic pregnancy
|
Time taken for normalization of Beta HCG(serial monitoring) OR 6 week after last injection of Methotrexate whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study pharmacokinetics of Methotrexate-C-max, Area under curve
2.To monitor the adverse drug effects associated with methotrexate
3. To study the correlation of methotrexate dose with efficacy, safety & pharmacokinetic data |
Time point for pharmacokinetic analysis-
Post methotrexate injection(0hour,2hour,12hour,
24hour) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design: Prospective, open label study Study Site: Study participants will be recruited from the septic labor room of the Department of Obstetrics and Gynecology, PGIMER Chandigarh. The blood sample will be processed and analysed at the Department of Pharmacology PGIMER Chandigarh. Patients will be recruited after getting approval from the ethics committee. Study Population: All the patients of unruptured tubal ectopic pregnancy will be screened and selected as per the predefined inclusion and exclusion criteria and recruited patients will be given complete information regarding the study. |