| CTRI Number |
CTRI/2024/02/062205 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of inflammatory markers and onset of labor in preterm pregnancy |
|
Scientific Title of Study
|
Association of inflammatory markers with time to onset of spontaneous labor in preterm prelabor rupture of membrane
|
| 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 BINDU BAJAJ |
| Designation |
Professor and Head of Department Department of Obstetrics and Gynaecology |
| Affiliation |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of Obstetrics and Gynaecology
VMMC and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9711067661 |
| Fax |
|
| Email |
bindubajaj15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BINDU BAJAJ |
| Designation |
Professor and Head of Department Department of Obstetrics and Gynaecology |
| Affiliation |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of Obstetrics and Gynaecology
VMMC and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9711067661 |
| Fax |
|
| Email |
bindubajaj15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr LIYA P J |
| Designation |
Post graduate resident |
| Affiliation |
VMMC and Safdarjung Hospital New Delhi |
| Address |
Department of Obstetrics and Gynaecology
VMMC and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7034709003 |
| Fax |
|
| Email |
liyaanakkara@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital New Delhi
|
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, New Delhi
110029
|
| Type of Sponsor |
Government 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 BINDU BAJAJ |
VMMC and Safdarjung Hospital |
Department of Obstetrics and Gynaecology
VMMC and Safdarjung Hospital New Delhi
New Delhi
DELHI |
9711067661
bindubajaj15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All hospitalized antenatal patients with preterm prelabor rupture of membrane with singleton pregnancy with gestational age between 28 weeks to 36 weeks + 6days |
|
| ExclusionCriteria |
| Details |
Patients with
Pre-eclampsia
Gestational Diabetes
Multiple pregnancy
Antepartum hemorrhage
Intrauterine death
Chorioamnionitis or any active infections
Any known chronic inflammatory conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know levels of IL 6, hsCRP, procalcitonin in patients with preterm prelabor rupture of membrane
|
Time to onset of labor from preterm prelabor rupture of membrane |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal and fetal morbidities
|
Preterm births
NICU admission
Postpartum febrile illness
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-02-2024 and end date provided 01-02-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patient with preterm prelabor rupture of membrane who are admitted in hospital willing to participate after counselling and fit into selection criteria will be recruited after obtaining written informed consent. Diagnosis of PPROM will be made by history of leaking and per-speculum examination. At admission routine antenatal workup, examination and investigations of all the enrolled patients will be done. Along with that blood samples for procalcitonin, IL 6, hsCRP will be collected and also at the time of onset of labor. Data will be recorded in pre-designed proforma. Results of IL6, hsCRP and procalcitonin will not be used for patient management. Management of the patients will be done as per hospital protocol |