| CTRI Number |
CTRI/2025/11/098136 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral Rehydration Solution Versus Conventional Intravenous Hydration In Management Of Normal Labor. |
|
Scientific Title of Study
|
Oral Rehydration Solution Versus Conventional Intravenous Hydration In Management Of Active Phase Of Labor In Low Risk Singleton Term Pregnancies 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 |
Pooja |
| Designation |
Post graduate trainee |
| Affiliation |
IPGMER SSKMH KOLKATA |
| Address |
Sskm doctors hostel,IPGMER SSKMH KOLKATA
Kolkata
WEST BENGAL
7000720
India |
| Phone |
7007153342 |
| Fax |
|
| Email |
kumaripooja2254@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARAYAN JANA |
| Designation |
Professor |
| Affiliation |
IPGMER SSKMH,KOLKATA |
| Address |
Gynaecology and obstetrics department , IPGMER SSKMH KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9331035392 |
| Fax |
|
| Email |
drnjana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NARAYAN JANA |
| Designation |
Professor |
| Affiliation |
IPGMER SSKMH,KOLKATA |
| Address |
Gynaecology and obstetrics department , IPGMER SSKMH KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9331035392 |
| Fax |
|
| Email |
drnjana@gmail.com |
|
|
Source of Monetary or Material Support
|
| MONETORY SUPPORT:NOT APPLICABLE
MATERIAL SUPPORT:ROUTINE SUPPLY FROM SSKM HOSPITAL
|
| Obstetrics and Gynaecology department
IPGMER SSKM Hospital 244 AJC Bose road Kolkata 700020 INDIA |
|
|
Primary Sponsor
|
| Name |
Departmental fund |
| Address |
Department of obstetrics and Gynaecology IPGME&R SSKM hospital
244 AJC Bose road KOLKATA 700020 INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Pooja |
IPGMER SSKM HOSPITAL, KOLKATA |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY -LABOUR ROOM
Kolkata
WEST BENGAL |
7007153342
kumaripooja2254@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE CHAIRPERSON ETHICS COMMITTEE, IPGMER SSKM KOLKTA |
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 |
Intravenous fluids |
Normal saline or Ringer lactate, Dextrose and sodium chloride.
500 ml of the Intravenous solutions(Normal saline or ringer lactate) to be given at 4- 6 hours interval for 24 hours or till 4- 6 hours after vaginal delivery whichever is later.
|
| Intervention |
Oral rehydration solution |
Oral rehydration solution(WHO fORMULA) The Laboring women will be allowed to drink the ORS (WHO formula ) instead of Intravenous fluids
(Comparator)which is conventionally given.
ORS is given orally during labor at 2- 4 hours intervals ; 1(one) litre of ORS is consumed in 3- 6 hours ad libitum (as desired). This is continued for whole duration of labor and continued for 4- 6 hours after delivery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy, term (37-41 weeks) gestation (37-41 weeks), low-risk status. |
|
| ExclusionCriteria |
| Details |
High-risk pregnancies, including those with pre-existing medical conditions, previous caesarean delivery, or pregnancies requiring induction of labour. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| With this study we expect to prove that giving oral hydration through low osmolar ORS is more physiological way of approach to the women who are in active stage of labour because it will not restrict her ambulation, it will also keep her well hydrated during labour and there is less chance of any complication cause due to intravenous fluid. |
Each laboring women will be assessed (at recruitment i.e, Baseline; then, every 4 hours during labor till delivery and day
1, day 2 (postpartum period) for all women having vaginal delivery or caesarean section and at the time of discharge from hospital.
Newborns are assessed at birth , every 4 hours till 24 hours and then daily(day 1, day 2, D3...... and till discharge).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
02/12/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposal should be directed to email kumaripooja2254@gmail.com
To gain access, data requestors will need to sign a data access agreement.
- For how long will this data be available start date provided 01-04-2027 and end date provided 01-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Oral rehydration solution is widely used on different clinical conditions and it is very safe. If use of oral rehydration solution ORS is equally effective compared to conventional IV hydration in active labour so far the maternal and fetal outcome is concerned then it will be highly beneficial to use ORS because of its simplicity safety and acceptability in wider scale. Our preliminary experience also suggests its benefits. Therefore the research hypothesis of this study is oral rehydration solution in active phase of labour is going to be beneficial when compared with conventional intravenous hydration. |