| CTRI Number |
CTRI/2024/10/075782 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective interventional study] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to predict the risk of preterm birth by measuring cervical length using ultrasonography |
|
Scientific Title of Study
|
Prediction of spontaneous preterm birth in women by transvaginal sonographic
measurement of cervical length between 18 to 24 weeks of gestation |
| 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 Kanishka Yadav |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
9871313306 |
| Fax |
|
| Email |
drkanishkay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Gupta |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
8368199481 |
| Fax |
|
| Email |
drsangeetamamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta Gupta |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
8368199481 |
| Fax |
|
| Email |
drsangeetamamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi
DELHI
110002
India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zaar Marg, New Delhi-110002 |
| 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 Kanishka Yadav |
Maulana Azad medical College |
Department of obstetrics and gynaecology,Maulana Azad Medical College, Bahadur Shah zafar Marg
New Delhi
DELHI |
9871313306
drkanishkay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O601||Preterm labor with preterm delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Transvaginal USG |
Transvaginal USG done between 18-24 weeks of gestation to record cervical length |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Pregnant women within the age group of 18-35 years.
2) Single live intrauterine pregnancy with gestational age 18-24 weeks.
3) Confirmation of gestational age with at least one ultrasound performed at
less than 16 weeks |
|
| ExclusionCriteria |
| Details |
1) Previous history of Preterm Delivery(less than 37 weeks)
2) Previous history of cervical Surgery
3) Any diagnosed uterine structural anomaly
4) Any fetal congenital malformation
5) Placenta previa in present pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Mean cervical length between 18-24 weeks of gestation
2) No. of women who deliver before 34 weeks of gestation |
upto 22 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) No. of women who deliver before 37 weeks of gestation
2) Proportion of women with cervical length less than 25 mm who deliver
before 34 weeks and 37 weeks
3) Proportion of women with cervical length more than 25 mm who deliver
before 34 weeks and 37 weeks |
upto 22 weeks |
|
|
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)
|
03/11/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
AIM: To measure cervical length between 18-24 weeks of gestation by transvaginal ultrasonography for prediction of spontaneous preterm birth Primary outcome:
1) Mean cervical length between 18-24 weeks of gestation 2) No. of women who deliver before 34 weeks of gestation
Secondary outcome: 1) No. of women who delivers before 37 weeks of gestation 2) Proportion of women with cervical length less than 25mm who delivers before 34 and 37 weeks of gestation 3) Proportion of women with cervical length more than 25 mm who delivers before 37 and 37 weeks of gestation Methodology: 100 Pregnant women seeking antenatal care between 18-24 weeks of gestation fulfilling inclusion and exclusion criteria will be recruited for the study. Cervical length measurement by transvaginal ultrasound will be done. All the women will be followed till delivery and the details of gestational age at delivery, mode of onset of labor, obstetrical outcome and neonatal outcome will be recorded
|