| CTRI Number |
CTRI/2024/08/072181 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assess the use of Modified Perineal Protection Device in labour |
|
Scientific Title of Study
|
Assessment of comparative efficacy of standard practice of labour with Modified perineal protection Device (MPPD) versus standard practice of labour alone in prevention perineal tear during second Stage of labour amongst Primi Parturient mothers:RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini H Moon |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynecology Nursing
Smt. Radhikabai Meghe Memorial College of Nursing
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970814240 |
| Fax |
|
| Email |
moonshalini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Mahakarkar |
| Designation |
Associate Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynecology Nursing
Smt. Radhikabai Meghe Memorial College Of Nursing
Sawangi Meghe,
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766565719 |
| Fax |
|
| Email |
manjum4725@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjusha Mahakarkar |
| Designation |
Associate Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynecology Nursing
Smt. Radhikabai Meghe Memorial College Of Nursing
Sawangi Meghe,
MAHARASHTRA
442001
India |
| Phone |
9766565719 |
| Fax |
|
| Email |
manjum4725@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| 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 |
| Shalini Moon |
Datta Meghe Institute of Higher Education and Research |
Department of Obstetrics and Gynecology Nursing
Smt. Radhikabai Meghe Memorial College
Sawangi (M)
Wardha
MAHARASHTRA |
9970814240
moonshalini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mothers in second stage of labor |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified perineal protection device (MPPD) |
Modified Perineal Protection Device (MPPD) will be used during second stage of labor process. |
| Comparator Agent |
Perineal support by perineal pad |
Standard practice will be followed during second stage of labor process |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Delivery with cephalic presentation
2. During Delivery Fully flexed Head
3. Birth Weight between 2.5 -3.5 kg
4. Age of mother between 18 -40 years
5. An understanding of both oral and written information in Hindi, Marathi and English.
|
|
| ExclusionCriteria |
| Details |
1. Mothers undergoing emergency caesarean section were excluded.
2. Mother with Breech presentation
3. Mother with high risk pregnancy (hypertension in pregnancy, Diabetes Mellitus , Cephalopelvic Disproportion etc)
4. Mother undergoing instrumental deliveries.(Forceps or Ventouse)
5. Mother participated in this type of study
6. Less than 32 weeks of gestation mother
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of Maternal outcome in terms of perineal tear
|
Assessment will be done immediately after delivery and at 6 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal and neonatal Outcomes
like Hemorrhage, Length of second stage of labour, Incidence of episiotomy, Status of perineal wound, Perineal pain, Sphincter function Urinary incontinence, faecal incontinence |
Will be assessed at delivery and at 6 weeks after delivery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a
randomized controlled trial, Participants will be selected
by simple random sampling technique. Modified perineal protection device
will be used for normal labour of primi parturient Mothers and will be compared with
normal delivery in terms of
maternal and fetal outcome. The Primary outcomes of primi parturient mother will be studied in terms of perineal tear. The secondary
outcome of primi parturient mother like ,Hemorrhage, Length of second stage of labour, Incidence of episiotomy, Status of perineal wound, Perineal pain and neonatal outcomes like Birth weight and APGAR score will be compared. |