| CTRI Number |
CTRI/2024/04/066109 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Serum Calcium level association in Primary Postpartum Hemorrhage-An Observational Study |
|
Scientific Title of Study
|
Association of Serum Calcium in Primary Postpartum Hemorrhage-An Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati kumari |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Obst and gynaecology
Rohilkhand medical college and hospital
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458828026 |
| Fax |
|
| Email |
swatibhagatmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ranjana Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Obst and gynae
Rohilkhand medical college and hospital
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9639527151 |
| Fax |
|
| Email |
ranj2036@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati kumari |
| Designation |
Resident doctor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Obst and gynaecology
Rohilkhand medical college and hospital
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458828026 |
| Fax |
|
| Email |
swatibhagatmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of obstetrics and gynaecology,Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital barielly
2&3006 |
| Type of Sponsor |
Private 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 Swati kumari |
Rohilkhand medical college and hospital |
Room no-1073, labour room, department of obstetrics and gynaecology.
Bareilly
UTTAR PRADESH |
9458828026
Swatibhagatmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,RMCH, Bareilly,U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O720||Third-stage hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Multigravida upto 3 pregnancies, Term pregnancy,Both Vaginal and caesarean deliveries, Patient in first/second stage of labour
Spontaneous onset of labour |
|
| ExclusionCriteria |
| Details |
1. Antepartum haemorrhage
2. Multiple pregnancy
3. Hydramnios
4. PIH
5. Bleeding disorder
6. Prolonged labour
7. Macrosomic baby
8. Patient with medical disorders. E.g., Kidney disease, Diabetes mellitus.
9. Patient on anticoagulants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study association between serum calcium levels and primary PPH |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse the association of serum calcium levels with occurrence and severity of atonic PPH.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
03/05/2024 |
| 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="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 - NO
|
|
Brief Summary
|
After delivery of study participants in both groups, blood loss will be assessed. The women with traumatic PPH will be excluded. Amniotic fluid expelled during delivery will be collected in separate collection bottle for Measurement of blood loss, the blood collected in trough after delivery of Placenta will be measured in collection bottle prepared with calibration at every 100ml,500ml and then at 1, 1.5, 2liters. Blood loss will be measured for at least one hour, until the active bleeding stops. At the time of shifting the patient, she will be provided with pre weighed standard perineal pads. The number of pads used in 24hrs will be weighed and the difference will be added to already measured blood loss. In case of caesarean deliveries, intraoperative blood loss will be quantified by measuring the blood in suction container and weighing the surgical and after being used during surgery. PPH will be classified on the basis of amount of blood loss as minor(500-1000ml) or major(>1000ml). Major will be further subdivided into moderate(1001-2000ml) and severe(>2000ml). Vital charting of women in study group will be done till 48hrs. After 48hrs of delivery, complete hemogram with hematocrit will be assessed for any change. Chi square test will be applied to compare the occurrence of PPH in both groups. |