| CTRI Number |
CTRI/2024/10/075111 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [umbilical artery blood ph] |
| Study Design |
Other |
|
Public Title of Study
|
Study on maternal and perinatal outcome in ORAL HYDRATION THERAPY WITH ORS VERSUS NO HYDRATION THERAPY in term pregnancies with isolated oligohydramnios |
|
Scientific Title of Study
|
A comparitive Study on maternal and perinatal outcome in ORAL HYDRATION THERAPY WITH ORS VERSUS NO HYDRATION THERAPY in term pregnancies with isolated oligohydramnios |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annapurna Hadalageri |
| Designation |
Pg student |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER BIJAPUR |
| Address |
OBGY Department
Shri B M Patil Medical College Hospital And Research centre.
Bijapur
Bijapur
KARNATAKA
586104
India |
| Phone |
9880135251 |
| Fax |
|
| Email |
annapurnahadalageri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasri yaliwal |
| Designation |
Professor |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OBGY Department
Shri B M Patil Medical College Hospital And Research centre
Bijapur
Bijapur
KARNATAKA
586104
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajasri yaliwal |
| Designation |
Professor |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OBGY Department
Shri B M Patil Medical College Hospital And Research centre
Bijapur
Bijapur
KARNATAKA
586104
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 2 shri b m patil medical college hospital and Research center bangaramma sajjan campus Vijayapura 586104 |
|
|
Primary Sponsor
|
| Name |
Dr Annapurna Hadalageri |
| Address |
OBGY Department
OBG OPD 2
Shri B M Patil Medical College Hospital And Research Centre
Bijapur |
| 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 Annapurna Hadalageri |
Shri B M Patil medical college hospital and reasearch centre Bijapur |
OBGY DEPARTMENT
Shri B M Patil medical college hospital and reasearch centre Bijapur
Bijapur
KARNATAKA |
9880135251
annapurnahadalageri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTE OF BLDE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP 2- 37-40weeks ,oligohydramnios with no hydration therapy |
umbilical cord artery ph values observed |
| Intervention |
oral hydration therapy |
37-40weeks POG Oligohydramnios with ORS therapy
Umbilical cord artery ph values observed |
| Intervention |
Oral hydration therapy |
GROUP 1- 37-40Weeks gestation,oligohydramnios with ORS Therapy
GROUP 2-37-40weeks,oligohydramnios no hydration therapy
umbilical cord artery ph values is observed in both groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
singleton pregnancies under cephalic presentation between gestational age of 37-40weeks with isolated oligohydramnios |
|
| ExclusionCriteria |
| Details |
Hypertensive disorder of pregnancy
PROM
Gestational diabetes mellitus
IUGR
Congenital malformations
IUD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the maternal and perinatal outcome of oral hydration therapy on outcome of pregnancies complicated by moderate oligohydramnios |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intrapartum events such as fetal distress,mode of delivery,neonatal outcome with respect to apgar score |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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="6"
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
|
The following study involves GROUP 1-antenatal mothers with term gestational age 37-40 weeks with oligohydramnios with ORS therapy this group will receive 2L of ORS everyday for 3days,after 3days AFI will be reassessed and decision for delivery will be made according to obstetrician. GROUP 2- antenatal mothers with term gestational age 37-40 weeks with oligohydramnios with no hydration therapy. Both groups shall be followed up for any intrapartum events such as fetal distress,mode of delivery,neonatal outcome with respect to apgar score,umbilical artery ph,meconium liquor,NICU Admission,RDS,birthweight shall be noted. |