| CTRI Number |
CTRI/2018/01/011455 [Registered on: 19/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Knowledge and acceptance about postpartum insertion of intrauterine device among antenatal cases |
|
Scientific Title of Study
|
A study to assess the efficacy of structured teaching programme on knowledge and acceptance of postpartum intra uterine (PPIUCD) as method of contraception among mothers attending antenatal OPD of a selected tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rejani R |
| Designation |
MSc Nursing Trainee officer |
| Affiliation |
College of Nursing,Armed Forces Medical College,Pune |
| Address |
Obstetric and Gynae Nsg Department.
College of Nursing Armed Forces Medical College,Pune 40
Obstetric and Gynae Nsg Department.
College of Nursing Armed Forces Medical College,Pune 40
Pune
MAHARASHTRA
411040
India |
| Phone |
9769885329 |
| Fax |
|
| Email |
rrajani.pillai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smitha Thadathil |
| Designation |
HOD Obs and Gynae Nsg Dept |
| Affiliation |
College of Nursing,Armed Forces Medical College,Pune |
| Address |
Obstetrical and Gynae Nsg Department College of Nursing,Armed Forces Medical College,Pune 40
Head Of the Department
Obstetrical and Gynae Nsg Department College of Nursing,Armed Forces Medical College,Pune 40
email:
mob:
Pune
MAHARASHTRA
411040
India |
| Phone |
7798718377 |
| Fax |
|
| Email |
smithathadathil75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rejani R |
| Designation |
MSc Nursing Trainee officer |
| Affiliation |
College of Nursing,Armed Forces Medical College,Pune |
| Address |
Obstetric and Gynaecology Nsg Department
College of Nursing,Armed Forces Medical College,Pune 40
22/5 Cariappa Enclave
wanowrie
near wanowrie post office
,Pune 40
Pune
MAHARASHTRA
411040
India |
| Phone |
9769885329 |
| Fax |
|
| Email |
rrajani.pillai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Researcher and Educational Institution
Armed Forces Medical college
Pune -40 |
|
|
Primary Sponsor
|
| Name |
Rejani R |
| Address |
Armed Forces Medical College,Pune 40 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rejani R |
Armed Forces Medical College |
Antenatal OPD
Department of Obs Gynae
Armed forces Medical College ,Pune,40
Pune
MAHARASHTRA |
9769885329
rrajani.pillai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell and Institution Ethical Committee Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Antenatal mothers who have completed 37 weeks of POG, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Antenatal counselling |
Antenatal counselling about contraceptives which is routinely given to antenatal mothers |
| Intervention |
Structured teaching on PPIUCD |
Structured teaching on PPIUCD as compared to routine antenatal counselling |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Registered term antenatal mothers who completed 37 weeks of gestation
2.Antenatal mothers fit as per WHO Medical Eligibility Criteria (MEC)
3.Willing to participate in the study
4.Who will deliver in the maternity setting of the study centre
|
|
| ExclusionCriteria |
| Details |
1.Antenatal mothers with bad obstetrical history
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceptance of PPIUCD as method of contraception |
Soon after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptance of Small family norm |
Acceptance of Small family norm |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an experimental study to assess the efficacy of structured teaching programme on knowledge and acceptance of postpartum intra uterine device (PPIUCD) as method of contraception as compared to the routine antenatal counselling among mothers attending antenatal OPD in a selected tertiary care hospital .100 Antenatal mothers who have completed 37 wks POG will be recruited and randomised into two groups.The experimental group will get structured teaching about PPIUCD and control group will get counselling on all contraceptive methods.Pre and post knowledge and acceptance will be assessed using a structured tool consisting of three parts.Post delivery acceptance of PPIUCD will be monitored and thus efficacy of structured teaching will be assessed. |