| CTRI Number |
CTRI/2023/08/056179 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
In a patient of preterm prelabor rupture of membranes what is the association of deepest vertical pocket and cervical length with the delivery latency period |
|
Scientific Title of Study
|
Association of transvaginal cervical length and deepest vertical pocket with delivery latency period in premature prelabour rupture of membranes |
| 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 Indu Chawla |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences |
| Address |
Dept of obstetrics and gynaecology
Atal Bihari Vajpayee Institute of Medical Sciences & Dr Ram Manohar Lohia hospital
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
induchawla2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vartika Dhingra |
| Designation |
1st year pg resident |
| Affiliation |
ABVIMS RML hospital |
| Address |
Dept of obstetrics and gynaecology , Atal Bihari Vajpayee Institute of Medical Sciences & Dr Ram manohar Lohia hospital New Delhi
Central
DELHI
272001
India |
| Phone |
09839547163 |
| Fax |
|
| Email |
vartika1098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vartika Dhingra |
| Designation |
1st year pg resident |
| Affiliation |
ABVIMS RML hospital |
| Address |
Dept of obstetrics and gynaecology , Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram manohar Lohia hospital New Delhi
New Delhi
DELHI
272001
India |
| Phone |
09839547163 |
| Fax |
|
| Email |
vartika1098@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences |
| Address |
Baba kharak singh road , near gurudwara bangla sahib , type 3 , cannaught palace,New Delhi |
| 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 |
| DrVartika Dhingra |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram manohar Lohia hospital |
baba kharak singh road, type 3 , connaught place , new delhi
New Delhi
DELHI |
01123365525
vartika1098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commmittee ,Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram monohar Lohia Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
antenatal women between 24 to 36+6weeks pog planned for expectant management
21 to 35 years of age
singleton pregnancy |
|
| ExclusionCriteria |
| Details |
active vaginal bleeding
showing signs of chorioamnionitis
cervical cerclage in situ
previous cervical surgery
patient in established labor |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| delivery latency period |
within 3 days 3-7 days , beyond 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fetomaternal outcome
chorioamnionitis |
period of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/08/2023 |
| 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="3"
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
|
40 antenatal singleton pregnancy with preterm prelabor rupture of membranes who are not in labor or showing signs of chorioamnionitis will be evaluated for deepest vertical pocket and transvaginal cervical length within 24 hrs of admission and the delivery latency period between rupture and delivery will be followed |