| CTRI Number |
CTRI/2025/09/094996 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of the previous procedure done for the abortion like medical and surgical(dilatation and evacuation,dilatation and curettage,suction and evacuation) methods on the cervical changes and what does the effect it cause in the next pregnancy which is a prospective observational study. |
|
Scientific Title of Study
|
Impact of prior abortion and termination method on cervical changes in subsequent singleton pregnancies |
| 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 Yerragudi Sravya |
| Designation |
Junior Resident ,MS OBG |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of OBG,Kasturba Medical College, MAHE,Madhav Nagar , Manipal,576104.
Udupi
KARNATAKA
576104
India |
| Phone |
8309496059 |
| Fax |
|
| Email |
sravya.chinnulu1956@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha B S |
| Designation |
Associate Professor, MS OBG |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of OBG,Kasturba Medical College, MAHE,Madhav Nagar , Manipal,576104.
Udupi
KARNATAKA
576104
India |
| Phone |
8660778169 |
| Fax |
|
| Email |
bssujata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yerragudi Sravya |
| Designation |
Junior Resident ,MS OBG |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of OBG,Kasturba Medical College, MAHE,Madhav Nagar , Manipal,576104.
Udupi
KARNATAKA
576104
India |
| Phone |
8309496059 |
| Fax |
|
| Email |
sravya.chinnulu1956@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yerragudi Sravya |
| Address |
Department of OBG,Kasturba Medical College, MAHE, Madhav Nagar, Manipal, 576104 ,Karnataka,India |
| Type of Sponsor |
Other [Dr Yerragudi Sravya] |
|
|
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 Yerragudi Sravya |
Kasturba Medical College |
Department of OBG, Kasturba Medical College, MAHE, Madhav Nagar, Manipal, 576104
Udupi
KARNATAKA |
8309496059
sravya.chinnulu1956@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gravida 2 women with previous history of abotion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All women attending to antenatal clinic or OPD of less than 11 weeks of gestation and willing to participate in the study during the study period are included. These women are categorised into cases such as pregnant women with a previous history of abortion of less than 24 weeks of gestation and controls such as primigravida or gravida two with no history of abortion. |
|
| ExclusionCriteria |
| Details |
Multiple pregnancies, spontaneous or induced delivery beyond 24 weeks of gestation in previous pregnancy, pregnancy with pre-gestational, diabetes mellitus or chronic hypertension, ectopic pregnancies or molar pregnancies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cervical changes during subsequent pregnancies in women with a history of abortion can be identified and addressed early on, ensuring that maternal and perinatal care remains and remains uncompromised.Early detection and proactive management are crucial for optimising outcomes. |
18 weeks - 20 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
30/09/2025 |
| 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="9"
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
|
To assess whether history of spontaneous or induced abortion before 24 weeks of gestation influences cervical changes in subsequent pregnancy, to evaluate whether history of abortion is associated with an increase risk of adverse perinatal outcomes compared with women with no history of abortion and to determine whether the number of previous abortions influences perinatal outcomes in comparison with the women with no history of abortion, the study is designed to evaluate the impact of abortion. History on multiple aspects of cervical changes, aiming to more accurately, assist the risk of Pritam delivery in comparison to women with Singleton pregnancies and no history of abortion. |