| CTRI Number |
CTRI/2022/12/048167 [Registered on: 15/12/2022] Trial Registered Prospectively |
| Last Modified On: |
08/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Placental localisation in pregnancy and its relation feto maternal outcome |
|
Scientific Title of Study
|
Mid trimester placental localization and its relation to feto maternal outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tripti Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room no. 2015 Department of obstetrics and gynaecology. Rohilkhand medical College and hospital Pilibhit bypass road Bareilly UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8433288211 |
| Fax |
|
| Email |
dr.triptigupta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripti Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical College and hospital |
| Address |
Room no. 2015 Department of obstetrics and gynaecology. Rohilkhand medical College and hospital Pilibhit bypass road Bareilly UP
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8433288211 |
| Fax |
|
| Email |
triptigupta3004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eeram |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical College and hospital |
| Address |
Department of obstetrics and gynaecology Rohilkhand medical College and hospital Pilibhit bypass road Bareilly U.P
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9760399434 |
| Fax |
|
| Email |
eeramsiddique@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital,Bareilly |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL PILIBHIT BYPASS ROAD BAREILLY UP 243006 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr TRIPTI GUPTA |
Rohilkhand medical College and hospital |
Room no. 2015, Department of obstetrics and gynaecology.Rohilkhand medical College and hospital, Pilibhit bypass road , Bareilly .UP 243006
Bareilly
UTTAR PRADESH |
8433288211
dr.triptigupta@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RMCH BAREILLY |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O438||Other placental disorders, (2) ICD-10 Condition: O439||Unspecified placental disorder, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
1) All pregnant women with singleton pregnancy between 18- 24 weeks of gestation attending the ante-natal OPD in RMCH. |
|
| ExclusionCriteria |
| Details |
1) Patients with previous history of eclampsia and pre -eclampsia in previous pregnancy or chronic hypertension.
2) Patient with history of pre- gestational diabetes and /or gestational diabetes.
3)Patient with history of uterine surgery (like previous cesarean section, myo-mectomy etc)
4)Women with multiple gestation
5)History of previous adverse fetal outcome
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict various adverse feto-maternal outcomes related to placental location
|
36 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early prediction of adverse feto maternal outcome ,to provide better feto maternal care |
36 weeks |
|
|
Target Sample Size
|
Total Sample Size="321"
Sample Size from India="321"
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)
|
18/12/2022 |
| 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
|
Not yet |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 - Proposals should be directed to [eeramsiddique@gmail.com].
- For how long will this data be available start date provided 01-11-2022 and end date provided 30-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The placenta plays a vital role in pregnancy. It is a reflection of intra uterine milieu and influence the feto- maternal outcomes. It develops from the chorionic villi at the implantation site at about fifth week of gestation and by ninth or tenth week the diffuse granular echo-texture of the placenta is clearly apparent at sonography.1 Implantation site decides the location of placenta & thus the pregnancy outcomes. The potential use of sonographic data for placental localization as a predictor of various feto maternal outcomes has been hinted to, in some prior studies. How-ever the evidence that we have is insubstantial .Thus this study aims to find out the relation between mid trimester placental localization & various feto maternal outcomes and establish its role as an early predictor . AIM – • To evaluate the association between the placental location and various pregnancy outcomes. OBJECTIVES – To predict various adverse feto-maternal outcomes related to placental location METHODOLOGY After taking approval from institutional ethic committee and receiving written informed consent from the patient, detailed history about age, parity, previous pregnancies, any clinical condition will be taken. For calculating gestation age of the patient, LMP will be asked and if LMP is not known earliest available USG will be used to calculate gestational age. General history will be taken to get baseline data of all participants such as age, parity, BMI, medical and obstetrics history. Trans-abdominal ultrasound using Samsung USG machine with 7 MHz transducer will be performed in the radiology department of RMCH of all ante natal women, who then will be observed and followed up till delivery. Placental location will be divided into anterior, posterior, lateral, fundal, central and outcomes related to theselocation will be noted and analysed.
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