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CTRI Number  CTRI/2025/12/099315 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see whether giving fluids through a vein (IV) or by drinking (oral) helps increase the water around the baby (amniotic fluid) in pregnant women who have low fluid levels 
Scientific Title of Study   The effect of maternal IV hydration vs Oral hydration on amniotic fluid index in oligohydramnios, A randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Syeda Sarah Bibi Fatima 
Designation  Junior Resident 2 
Affiliation  Jawaharlal Nehru Medical College, Belagavi, Karnataka 
Address  Departments of Obstetrics and Gynaecology Jawahrlal Nehru Medical College, Belagavi

Belgaum
KARNATAKA
590019
India 
Phone  9505792792  
Fax    
Email  sfathima1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Kamal Patil 
Designation  Professor, Department of Obstetrics and Gynaecology 
Affiliation  Jawaharlal Nehru Medical College, Belagavi, Karnataka 
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Belagavi


KARNATAKA
590019
India 
Phone  9505792792  
Fax    
Email  kamalpatil1967@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Syeda Sarah Bibi Fatima 
Designation  Junior Resident 2 
Affiliation  Jawaharlal Nehru Medical College, Belagavi, Karnataka 
Address  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Belagavi


KARNATAKA
590019
India 
Phone  9505792792  
Fax    
Email  sfathima1@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Syeda Sarah Bibi Fatima 
Address  Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, 590010 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Syeda Sarah BIbi Fatima  KAHERs Dr. Prabhakar Kore Hospital and Medical Reseearch Centre  Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Belagavi
Belgaum
KARNATAKA 		 9505792792

sfathima1@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O410||Oligohydramnios,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous hydration  Intravenous hydration, Two litres of zero point four five percent Normal Saline will be given through intravenous route for a period of two hours once daily under medical supervision. Maternal pulse, blood pressure and urine will be recorded before and after  
Intervention  Oral hydration  Oral hydration, Two litres of plain drinking water will be consumed orally over a period of two hours once daily under supervision. Maternal pulse, blood pressure and urine will be recorded before and after hydration. 
Comparator Agent  Oral hydration versus Intravenous hydration  Oral hydration, Two litres of plain drinking water will be consumed orally over a period of two hours once daily under supervision. Maternal pulse, blood pressure and urine will be recorded before and after hydration. Intravenous hydration, Two litres of zero point four five percent Normal Saline will be given through intravenous route for a period of two hours once daily under medical supervision. Maternal pulse, blood pressure and urine will be recorded before and after  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Singleton pregnancy
Gestational age between 28 to 40 weeks
Diagnosed with AFI less than 8 cm
Willingness to participate and provide informed consent 
 
ExclusionCriteria 
Details  Multiple pregnancies
Fetal congenital anomalies
Ruptured membranes or active labour
Any condition where oral or IV hydration is contraindicated 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of maternal IV hydration with oral hydration on the amniotic fluid index (AFI) in cases of oligohydramnios diagnosed with ultrasonography  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   28/12/2025 
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  

Oligoamnios, defined as an amniotic fluid index (AFI) less than or equal to 5 cm, is associated with intrauterine growth restriction, umbilical cord compression, fetal distress, and increased cesarean rates. Maternal hydration, oral and intravenous (IV) is a simple, non-invasive intervention to improve AFI, but comparative efficacy remains underexplored.
To compare the effects of maternal IV and oral hydration on AFI in pregnancies complicated by oligoamnios.
In this hospital-based randomized controlled trial, 60 pregnant women (28–40 weeks gestation) with oligoamnios were assigned to IV hydration (2 L of 0.45% normal saline over 2 hours) or oral hydration (2 L of water over 2 hours). AFI was measured before and after intervention.

 
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