| CTRI Number |
CTRI/2024/06/069041 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MIDWIFERY LED COMPREHENSIVE CARE APPROACH] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Midwifery-led care intervention to improve perinatal outcome in women with Hypertensive Disorders of Pregnancy. |
|
Scientific Title of Study
|
Effect of midwifery led comprehensive care approach on perinatal outcome among women with Hypertensive disorders at Sum Hospitals of Bhubaneswar, Odisha
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADHUSMITA NAYAK |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SUM NURSING COLLEGE, BHUBANESWAR |
| Address |
ROOM No- 4, SECOND FLOOR, SUM NURSING COLLEGE, BHUBANESWAR.
Khordha
ORISSA
751003
India |
| Phone |
08847852784 |
| Fax |
|
| Email |
madhusmitanayak@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAVATI TRIPATHY |
| Designation |
DEAN |
| Affiliation |
SUM NURSING COLLEGE, BHUBANESWAR |
| Address |
DEAN ROOM, GROUND FLOOR, SUM NURSING COLLEGE, BHUBANESWAR
Khordha
ORISSA
751003
India |
| Phone |
9437035927 |
| Fax |
|
| Email |
dean.snc@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAVATI TRIPATHY |
| Designation |
DEAN |
| Affiliation |
SUM NURSING COLLEGE, BHUBANESWAR |
| Address |
DEAN ROOM, GROUND FLOOR, SUM NURSING COLLEGE, BHUBANESWAR
Khordha
ORISSA
751003
India |
| Phone |
9437035927 |
| Fax |
|
| Email |
dean.snc@soa.ac.in |
|
|
Source of Monetary or Material Support
|
| SUM Nursing College, Faculty of nursing, campus-2,Siksha O Anushandhan DTU, Bhubaneswar, Odisha, india, Pin- 751003 |
|
|
Primary Sponsor
|
| Name |
Madhusmita Nayak |
| Address |
SUM Nursing College,Faculty of nuring, Campus-2, K-8, Kainganagar, Bhubaneswar, Odisha, India, Pin- 751003 |
| 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 |
| DR PRAVATI TRIPATHY |
INSTITUTE OF MEDICAL SCIENCE & SUM HOPSITAL |
Room No-1, ANTENATAL OPD, GROUND FLOOR, DEPARTMENT OF OBSTETRICS
Khordha
ORISSA |
9437035927
dean.snc@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPIAL, SIKSHA O ANUSHANDHAN (DEEMED TO BE UNIVERSITY)(ACCREDITATED BY NAAC OF UGC WITH A GRADE) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control Group |
In control group, the women diagnosed with HDP, will receive the standard treatment |
| Intervention |
MIDWIFERY LED COMPREHENSIVE CARE APPROACH |
Midwifery led comprehensive care approach includes an educational session for women with diagnosed HDP for 60min in first visit (regarding Risk analysis, regular antenatal visits, Daily fetal movement count (DFMC), Home BP monitoring and recording, DASH diet, exercise details, drugs and use of safe pregnancy & birth mobile App), Appropriate intrapartum monitoring & care and postpartum follow up (6weeks) through what’s app group. This care was provided by a registered midwife.
Self-daily home monitoring with recording includes BP (if possible), Fetal movement count, visible abnormal weight gain, pedal edema. Immediate information should be given to midwifery I/C if the BP exceeds 140/90mmhg, fetal movement is 10 in 12 hr/day for 2 consecutive days or no fetal movement/24hr, any abnormal weight gain (not because of pregnancy) and presence of pedal edema. Apart from that weekly feedback was taken by the midwife telephonically.
Total 5 contact visits was there at 20weeks, 22-30week, 31-36week, 36-delivery and at the time of delivery antenatally and 1 contact visit postnatally and the parameters like FHR, BP, weight gain and proteinuria was checked post to the intervention.
This program was developed after consultation with Obstetrician and dietician experts and was validated before use.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Female |
| Details |
1- All women with Hypertensive disorders of pregnancy
2- At any Gestational age
3- Must have minimum of 5 contact visit antenatally and 1 contact postnatally.
4- Availability of complete records |
|
| ExclusionCriteria |
| Details |
1- Women attending OPD first time after 30 week of gestation
2- women with HDP who declined to participate in the study
3- Those with hypertension who delivered in other health facilities
4- mothers with comorbid chronic medical disorders like diabetes, severe anemia, renal disease, cardiac disease.
5- Mothers with epilepsy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Perinatal outcome among women with HDP |
after 20week of gestation up to delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Maternal satisfaction
2. Quality of life
3. Adherence to medication |
after 20week of gestation up to delivery. |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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 1 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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
|
Primary purpose of the protocol: As because the hypertensive disorders of pregnancy is contributing to both maternal & neonatal mortality in India. Hence the authors has come up with this trial to introduce an midwifery led intervention with continuous follow up of mothers up till the delivery and postnatal period as well to see its effect on the perinatal outcome.
Hypothesis: 1.H01:there is no significant difference between post test score of experimental and control group in terms of perinatal outcome. 2. H02:there is no significant difference between post test score of experimental and control group in terms of maternal satisfaction. 3.H03 : There is no significant change in mothers blood pressure, BMI & FHR before, during and after receiving intervention 4.H04 : there is no significant association between perinatal outcome and maternal satisfaction with selected sociodemographic variable
|