| CTRI Number |
CTRI/2024/05/067769 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Maternal and perinatal outcomes in advanced maternal age |
|
Scientific Title of Study
|
Maternal and Perinatal Outcomes in Advanced Maternal Age - A Cross Sectional Study at KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre |
| 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 A Disha Gowda |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynecology, First Floor, Jawaharlal Nehru Medical college, KLE university, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7337702856 |
| Fax |
|
| Email |
adishagowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadevi Savanur |
| Designation |
Associate Professor, Obstetrics and Gynecology |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynecology, First Floor, Jawaharlal Nehru Medical college, KLE university, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9880515045 |
| Fax |
|
| Email |
drdevim30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Disha Gowda |
| Designation |
PG RESIDENT |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynecology, First Floor, Jawaharlal Nehru Medical college, KLE university, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
7337702856 |
| Fax |
|
| Email |
adishagowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi ,Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
A Disha Gowda |
| Address |
Room Number-GNGR 2, Akkamahadevi Ladies Hostel, JNMC Campus, Nehru Nagar, KLE University, Belagavi,Pincode- 590010, Karnataka, India. |
| Type of Sponsor |
Other [self] |
|
|
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 A Disha Gowda |
Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
G-1 floor, labour room , Department of Obstetrics and Gynecology,Dr Prabhakar Kore Hospital and Medical Research Centre
Belgaum
KARNATAKA |
7337702856
adishagowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O095||Supervision of elderly primigravida and multigravida, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal women with age more than or equal to 35 years at admission or at delivery with age confirmed by Aadhar card |
|
| ExclusionCriteria |
| Details |
Antenatal women not consenting for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the maternal and perinatal outcomes in Advanced Maternal age |
42 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the maternal and perinatal outcomes in advanced maternal age with and without comorbidities
To know the reasons of advanced maternal age |
42 weeks |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
01/06/2024 |
| 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
|
- Advanced maternal age is defined as women who are 35 years or older at estimated date of delivery. Majority of countries have shown an increase in the average age of first pregnancy, reflecting a global trend toward late age of pregnancy. Chronic medical complications are more prevalent in older women. Subfertility, antepartum hemorrhage, malpresentation, postpartum hemorrhage has led to increased incidence of instrumental deliveries and cesarean sections.
- Most of the research carried out on obstetric outcomes in advanced maternal age are from the western world. Few studies are carried out in India especially in Karnataka. Hence, the aim of this study is to find out the effect of advanced maternal age on maternal and perinatal outcome in this setting. The result obtained can be used for pre conceptional counselling and for creating a tailored plan of antenatal care and management. It will also help in taking necessary preventive measures in order to avoid the complications.
Study Protocol - All pregnant woman with advanced age admitted in the labor room at KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre will be recruited in the study after the informed consent is obtained. Patients who satisfy the inclusion criteria are recruited in the study. Patients age will be verified by Aadhar card. ·
Patients with advanced
maternal age will be identified and detailed history which includes the
antenatal history, menstrual history, obstetric history, clinical examination
and laboratory investigations, will be collected from the case records Perinatal outcomes will be noted from the case records which include birth weight, gestational age of delivery, any chromosomal abnormalities, causes of NICU admission and course in NICU |