| CTRI Number |
CTRI/2025/06/088212 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Excess Amniotic Fluid on Mothers and Babies During Pregnancy: A Study at KLE’s Dr. Prabhakar Kore Hospital, Belagavi |
|
Scientific Title of Study
|
Perinatal and maternal outcomes of excess liquor in pregnancy: An observational study at KLES Dr. Prabhakar Kore Hospital and Research Centre, Belagavi. |
| 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 Sangamesh D S |
| Designation |
MS post graduate |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of obstetrics and gynaecology, Jawaharlal Nehru medical college, Nehru Nagar, belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9535756984 |
| Fax |
|
| Email |
sangameshds17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshita Pujar |
| Designation |
Professor and HOD |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of obstetrics and gynaecology, Jawaharlal Nehru medical college, Nehru Nagar, belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9448142989 |
| Fax |
|
| Email |
yvpujar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yeshita Pujar |
| Designation |
Professor and HOD |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of obstetrics and gynaecology, Jawaharlal Nehru medical college, Nehru Nagar, belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9448142989 |
| Fax |
|
| Email |
yvpujar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr. Sangamesh D S |
| Address |
Department of Obstetrics and Gynaecology, KAHERs Jawaharlal Nehru
Medical College, Nehru nagar, Belagavi 590010 |
| 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 Sangamesh D S |
KLEs Dr. Prabhakar Kore Hospital and MRC |
Department of Obstetrics and Gynaecology
Belgaum
KARNATAKA |
9535756984
sangameshds17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O403||Polyhydramnios, third trimester, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.40 Month(s) |
| Age To |
9.70 Month(s) |
| Gender |
Female |
| Details |
1. Patient with singleton pregnancy
2. Ultrasound finding of AFI more than 18
3. Gestational age of more than 28 weeks period of gestation |
|
| ExclusionCriteria |
| Details |
1. Multiple gestation
2. AFI calculated by SDVP |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- gestational age at delivery
- possible etiological factors causing abnormal liqour volume
- rate of induction
- liqour colour
- number of vaginal, cesarean and instrumental deliveries
- indication for cesarean section
- intra partum complications
- post partum complications |
During
first ANC visit, during
delivery and immediately
postpartum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
fetal outcome such as
- 5 mins apgar
- birth weight
- NICU admission
- perinatal morbidity & mortality |
Immediately post delivery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/06/2025 |
| 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="0"
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
|
This observational, prospective cohort study aims to evaluate the maternal and perinatal outcomes associated with excess amniotic fluid (AFI >18 cm) in pregnant women. Conducted over one year at KLES Dr. Prabhakar Kore Hospital, the study will analyze factors such as delivery methods, complications, and NICU admissions. It includes a sample size of 73 and utilizes convenient sampling of eligible patients. The study seeks to determine the impact of polyhydramnios on maternal and neonatal health and to investigate its causes. The need for this study arises from the high incidence of perinatal mortality and congenital anomalies associated with polyhydramnios and the lack of extensive research in Indian contexts, particularly in Karnataka. |