| CTRI Number |
CTRI/2008/091/000003 [Registered on: 06/02/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
A randomized controlled trial to study the effect of intravenous hydration on the course of labor |
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Scientific Title of Study
|
A randomized controlled trial to study the effect of intravenous hydration on the course of labor |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Kavitha Abraham |
| Designation |
|
| Affiliation |
|
| Address |
Department of Obstetrics & Gynaecology,Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282314 |
| Fax |
|
| Email |
alphakavi@hotmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr.Kavitha Abraham |
| Designation |
|
| Affiliation |
Department of Obstetrics & Gynaecology,Christian Medical College and Hospital,Vellore |
| Address |
Department of Obstetrics & Gynaecology,Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282314 |
| Fax |
|
| Email |
alphakavi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Kavitha Abraham |
| Designation |
|
| Affiliation |
|
| Address |
Department of Obstetrics & Gynaecology,Christian Medical College and Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282314 |
| Fax |
|
| Email |
alphakavi@hotmail.com |
|
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Source of Monetary or Material Support
|
| Christian Medical College and Hospital,Vellore |
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Primary Sponsor
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| Name |
Christian Medical College and Hospital,Vellore |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Kavitha Abraham |
Department of Obstetrics & Gynaecology,Christian Medical College and Hospital |
,Department of Obstetrics & Gynaecology,Christian Medical College and Hospital,Vellore-632004
Vellore
TAMIL NADU |
04162282314
alphakavi@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board,Christian Medical College,Vellore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Effect of adequate hydration on duration of active labor, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Ringer lactate |
125ml/hr vs 250ml/hr during active labor |
| Comparator Agent |
Oral hydration alone |
oral fluids as and when required during active labour,which is later measured. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1) Primigravida
2) Uncomplicated Pregnancies
3) Spontaneous onset of labour
4) Singleton gestation
5) Cephalic presentation
6) In active labour with cervical dilation 3 cms
7) Pregnancy duration more than or equal to 37 weeks
|
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| ExclusionCriteria |
| Details |
NonVertex presentation
High risk pregnancy
Previous LSCS
Induction of labour
Twins
Chorioamnionitis
Renal/cardiac disease or pre eclampsia
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Total duration of labour in minutes
Frequency of prolonged labour - > 12 hours
Incidence of LSCS due to failure to progress
Frequency of oxytocin administration for augmentation
Incidence of operative vaginal delivery
|
6 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| Maternal and neonatal complications
- Chorioamnionitis
- Endometritis
- Wound infection
- PPH
- Pulmonary oedema
- NICU admissions and sepsis
|
6 months |
|
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Target Sample Size
|
Total Sample Size="180"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/08/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This study is a randomized,double blind,parallel group,active cotrolled trial to study the effect of intravenous hydration on the course of labor.There will be 3 groups receiving IV Ringer125ml/hr,250ml/hr and oral hydration respectively.Each group will have 60 patients and the study is conducted at C.M.C.Hospital,Vellore,India over 6 months.The primary outcomes will include total duration of labour in minutes, frequency of prolonged labour - > 12 hours, incidence of LSCS due to failure to progress,frequency of oxytocin administration for augmentation and incidence of operative vaginal delivery.The secondary outcomes will be Maternal and neonatal complications like chorioamnionitis,endometritis,wound infection, PPH,pulmonary edema,NICU admissions and sepsis. |