| CTRI Number |
CTRI/2024/07/070533 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of IM inj 10U oxytocin V/s Oral tablet Misoprostol in active management of third stage of labour |
|
Scientific Title of Study
|
Comparative study of Oxytocin 10 IU IM V/s Oral Misoprostol 600 MCG in active management of third stage of labour |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Kshirsagar |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune |
| Address |
Department of obstetrics and gynaecology, Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9689904101 |
| Fax |
|
| Email |
shilpa.kshirsagar@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Kshirsagar |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune |
| Address |
Department of obstetrics and gynaecology, Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9689904101 |
| Fax |
|
| Email |
shilpa.kshirsagar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Heena Vaswani |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune |
| Address |
Department of obstetrics and gynaecology, Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820079168 |
| Fax |
|
| Email |
heenavaswani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College and Hospital and research centre, Pimpri , Pune 411018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Heena Vaswani |
Dr D Y Patil medical college and hospital and research centre, Pimpri, Pune |
Department of obstetrics and gynaecology, labour room, ward number 58
Pune
MAHARASHTRA |
9820079168
heenavaswani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee, Dr D Y Patil medical college, hospital and research institute, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Oxytocin |
10 IU Intramuscularly after delivery of baby |
| Comparator Agent |
Tablet Misoprostol |
600 mcg orally after delivery of baby |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with gestational age more than 28 weeks and at low risk , undergoing vaginal delivery.
2. Patients having the ability and willingness to provide an informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Hb under 8gm
2. Previous pregnancy associated with PPH.
3. Patient with traumatic PPH due to genital laceration.
4. Antepartum haemorrhage.
5. Multiple pregnancies.
6. Non-cephalic presentation.
7. Multipara, big baby, fibroid uterus, polyhydramnios
8. Previous LSCS
9. Hypertension, pre-eclampsia or pregnancy induced hypertension.
10. Intra uterine death.
11. Seizures, diabetes, renal anomalies, cardiac arrest or coagulation disorders.
12. Choriamnionitis
13. Polyhydraminos.
14. Epidural anaesthesia.
15. Bronchial asthma or respiratory disorders.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery and on day 2 post-delivery of two intervention groups.
2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage
|
1. To measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haematocrit after comparing these in both pre-delivery-baseline and post-delivery at day 2 and on discharge of two intervention groups.
2. To assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage post delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To ascertain the side effects of the IM oxytocin & oral misoprostol
2. Need of blood transfusion
|
To be decided at the time of discharge on day 2 after delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "146"
Final Enrollment numbers achieved (India)="146" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized,parallel group prospective comparative study of Oxytocin 10 IU IM V/S Oral Misoprostol 600 mcg in active management of third stage of labour that will be conducted in India. The primary outcome is to measure the blood loss in the third stage of labour by changes in the level of haemoglobin and haemotocrit after comparing these in both pre and post delivery of two intervention groups and also to assess need of additional uterotonics or surgical methods for the control of postpartum haemorrhage in two intervention groups. The secondary outcomes will be to ascertain the side effects of oxytocin and misoprostol in two intervention groups and also the need of blood transfusion. . |