| CTRI Number |
CTRI/2026/01/100256 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized controlled trial to compare the effectiveness of Metformin in prolonging period of gestation in Pre-eclampsia without severe features to standard treatment |
|
Scientific Title of Study
|
A Randomized controlled trial to compare the effectiveness of Metformin in prolonging period of gestation in Pre-eclampsia without severe features to standard treatment |
| 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 Shinde Manali Madhukar |
| Designation |
Junior Resident (Post graduate) |
| Affiliation |
Shri B.M Patil Medical college Hospital and Research centre |
| Address |
OBG OPD No- 2, Shri B.M Patil Medical college, Hospital and Research Centre, Bangaramma sajjan campus, Solapur road, Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
9423576025 |
| Fax |
|
| Email |
manalishinde25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelamma Patil |
| Designation |
Professor |
| Affiliation |
Shri B.M Patil Medical college Hospital and Research centre |
| Address |
OBG OPD No- 2, Shri B.M Patil Medical college, Hospital and Research Centre, Bangaramma sajjan campus, Solapur road, Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
9845068074 |
| Fax |
|
| Email |
neelamma.patil@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shinde Manali Madhukar |
| Designation |
Junior Resident (Post graduate) |
| Affiliation |
Shri B.M Patil Medical college Hospital and Research centre |
| Address |
OBG OPD No- 2, Shri B.M Patil Medical college, Hospital and Research Centre, Bangaramma sajjan campus, Solapur road, Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
9423576025 |
| Fax |
|
| Email |
manalishinde25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manali Shinde |
| Address |
OBG OPD No-2, Shri B.M Patil Medical college, Hospital, Research centre, Vijayapura, Karnataka- 586103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shinde Manali Madhukar |
Shri B.M Patil Medical college, Hospital and Research centre |
OBGY OPD No.2
Bangaramma sajjan campus, Solapur road, Vijayapura
Bijapur
KARNATAKA |
9423576025
manalishinde25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
METFORMIN |
Depending on block randomization, patient with pre-eclampsia without severe features alloted will be given 500mg of oral extended release metformin daily three times a day until delivery along with standardised treatment protocol |
| Comparator Agent |
STATNDARD PROTOCOL |
Depending on block randomization, patient with pre-eclampsia without severe features alloted will be treated as per standardized treatment protocol (Antihypertensives: Tab. Labetalol 100mg or Tab. Depin R) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with age more than or equal to 18 years of age.
2. Women diagnosed with pre-eclampsia without severe features with period of gestation more than 28 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Multiple pregnancies
2. Women with chronic hypertension, gestational hypertension.
3. Women with gestational diabetes mellitus.
4. Women with contraindications to metformin (Renal dysfunction, hypersensitivity to metformin, Acute or chronic metabolic acidosis, Impaired hepatic function)
5. Women with pre-existing conditions that could interfere with the study outcomes (e.g., severe renal impairment, liver disease).
6. Women who are already on medications that could affect the study outcomes (glyburide, furosemide or cationic drugs)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of days prolonged in metformin group versus group on standardised treatment protocol in patients with pre-eclampsia without severe features |
The period of gestation at time of termination of pregnancy will be considered |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To investigate the neonatal outcomes of infants born to mothers treated with metformin in terms of birth weight, RDS, hypoglycemia, NICU admissions & neonatal death compared to mothers in the control group.
2. To assess for any other side effects like diarrhea, nausea, vomiting, gastritis, lactic acidosis symptoms in metformin treated mothers. |
1. The neonatal outcomes will be assesed at birth.
2. Side effects will be assed during pregnancy period when patient is being treated with metformin |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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="0"
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
|
This is a single centre, open- label, parallel- group, block- randomized, superiority randomized controlled trial with individual participant randomization. Phase iv trial evaluating metformin as an adjunct to standard treatment in women wih pre-eclampsia without severe features beyond 28 weeks of gestation, Patients with mild pre-eclampsia who will meet the inclusion criteria and will consent to the study will be recruited as cases, and consenting pre-eclamptic individuals will be recruited as controls. A study number will be assigned to each recruited subject. The subjects will be randomly divided and will be allotted according to computer randomized table of Block 4. Gestational age will be estimated from the reliable last menstrual period or early obstetric ultrasound scan. ยท Patients will be classified into two groups. GROUP 1: 500mg of oral extended release metformin daily in three times a day until delivery along with standardised treatment protocol GROUP 2: Standardised treatment protocol (Antihypertensives: Tab. Labetalol 100mg or Tab.Depin R) Patients will be allotted according to the computer randomized table of Block 4 with allocation concealement by sequentially numbered, opaque, sealed envelopes. The primary outcome is duration of pregnancy prolongation in days from randomization to delivery. Secondary outcomes include selected neonatal outcomes and maternal adverse effects.
|