| CTRI Number |
CTRI/2026/03/106092 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Cervical Biomarker Test for Early Prediction of Preterm Birth in Pregnant Woman Presenting with Suspected Preterm Labor |
|
Scientific Title of Study
|
Evaluation Of Predictive Accuracy and Clinical Utility of Phosphorylated Insulin Like Growth Factor Binding Protein-1 In Suspected Preterm labor. |
| 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 TANISHQA DEEPAK KADU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of obstetrics and gynecology, Jawaharlal Nehru Medical College, Sawangi meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07039748411 |
| Fax |
|
| Email |
kadutanishqa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DEEPTI SHRIVASTAVA |
| Designation |
PROFFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of obstetrics and gynecology, Jawaharlal Nehru Medical College, Sawangi meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07039748411 |
| Fax |
|
| Email |
deepti_shrivastava69@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TANISHQA DEEPAK KADU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of obstetrics and gynecology, Jawaharlal Nehru Medical College, Sawangi meghe
Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07039748411 |
| Fax |
|
| Email |
kadutanishqa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JAWHARLAL NEHRU MEDICAL COLLEGE |
| Address |
AVBRH,SAWANGI MEGHE WARDHA, INDIA
PINCODE: 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 TANISHQA DEEPAK KADU |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
Department of obstetrics and gynecology, Jawaharlal Nehru Medical College, Sawangi meghe
Wardha
Wardha
MAHARASHTRA |
07039748411
kadutanishqa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PRETERM LABOR |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between gestational age between 28 weeks to 37 weeks
Presenting with symptoms of threatened preterm labor(i.e regular uterine contractions occurring every 10ish or more frequent, pelvic pressure, low dull backache, vaginal spotting, feeling of abdominal tightening) intact membranes at the time of testing
Cervical dilatation less tha 3cm on initial assessment
Willingness to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Ruptured membranes( Confirmed or suspected premature rupture of membranes)
Active vaginal bleeding or placenta previa
Cervical dilatation greaterthan 3 cm or established labor
Known fetal anomalies or Intrauterine fetal demise
Any condition requiring immediate delivery( e.g. severe preeclampsia, fetal distress)
Unwillingness to provide consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of delivery within 7 days of positive immunoenzymatic dipstick test |
Incidence of delivery within 7 days of positive immunoenzymatic dipstick test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of delivery within 14 days of testing
Neonatal outcomes(Birth Weight, APGAR Score, NICU Admission, Neonatal morbidity & mortality)
Gestational age at the time of delivery
Mode of delivery(normal vs caserean)
Use of interventions(corticosteroids,mgso4, tocolytics)
Hospital admission & length of maternal stay
|
7 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/03/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Preterm labor is a major contributor to neonatal illness and mortality, particularly in developing countries. Women presenting with symptoms of threatened preterm labor often require hospitalization and treatment; however, many do not deliver preterm. This results in unnecessary interventions, increased healthcare costs, and psychological stress.
Phosphorylated insulin-like growth factor binding protein-1 (phIGFBP-1) is a biochemical marker released from the decidua when separation of fetal membranes begins prior to labor. Its detection in cervical secretions may help identify women at true risk of imminent preterm delivery.
The present study aims to evaluate the predictive accuracy and clinical utility of bedside phIGFBP-1 testing in pregnant women between 28 and 37 weeks of gestation presenting with symptoms of threatened preterm labor and intact membranes. Participants will be tested using a rapid immunoassay kit and followed to determine delivery outcomes, particularly delivery within seven days of testing.
The findings of this study may help determine whether phIGFBP-1 can serve as a reliable tool to guide clinical decision-making, reduce unnecessary hospital admissions and interventions, and improve maternal and neonatal outcomes in a tertiary care setting. |