| CTRI Number |
CTRI/2014/12/005267 [Registered on: 09/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of skin contact on mother and baby immediately after normal delivery |
|
Scientific Title of Study
|
Effect of immediate skin-to-skin contact on selected maternal and newborn outcomes after normal delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Greeshma Sebastian |
| Designation |
MSc student |
| Affiliation |
Christian Medical College |
| Address |
MSc(N)2nd year, college of nursing, Christian Medical College, Vellore
Ida Scudder road, Vellore, Tamilnadu.
Vellore
TAMIL NADU
632004
India |
| Phone |
9787406220 |
| Fax |
|
| Email |
greeshmasebastian1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Greeshma Sebastian |
| Designation |
MSc student |
| Affiliation |
Christian Medical College |
| Address |
MSc(N)2nd year, college of nursing, Christian Medical College, Vellore
Ida Scudder road, Vellore, Tamilnadu.
Vellore
TAMIL NADU
632004
India |
| Phone |
9787406220 |
| Fax |
|
| Email |
greeshmasebastian1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Greeshma Sebastian |
| Designation |
MSc student |
| Affiliation |
Christian Medical College |
| Address |
MSc(N)2nd year, college of nursing, Christian Medical College, Vellore
Ida Scudder road, Vellore, Tamilnadu.
Vellore
TAMIL NADU
632004
India |
| Phone |
9787406220 |
| Fax |
|
| Email |
greeshmasebastian1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional review board, Christian medical college, Vellore. |
|
|
Primary Sponsor
|
| Name |
Christian medical college |
| Address |
Ida Scudder road, Vellore, Tamilnadu |
| 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 Reeta Vijayaselvi |
Labour room, Christian Medical College, Vellore |
Christian Medical College, Ida scudder road, Vellore, Tamilnadu.
Vellore
TAMIL NADU |
04162286185
reetavijayaselvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, CMC, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
newborn breastfeeding behaviour,thermoregulation, and maternal duration of third stage of labour, blood loss during third and fourth stage of labour and pain perception during perineal wound suturing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional care |
Soon after birth, time of birth is noted, the cord will be cut, the baby is taken to the resuscitation area, wiped,and kept under warmer till mothers care is over. the time of placental delivery is noted. after 30 minutes of birth, babys temperature, breastfeeding behaviour, mothers blood loss and pain perception are measured |
| Intervention |
immediate skin-to-skin contact |
Soon after birth, time of birth is noted, the cord will be cut, the baby is wiped, put on the mothers bare chest and covered with a blanket and cap. This is continued for 30 minutes. while the baby is on chest, the time of placental delivery is noted.after 30 minutes of intervention, babys temperature, breastfeeding behaviour, mothers blood loss and pain perception are measured. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Female |
| Details |
1:Primigravida women who do not have any risk factors or may have one or more of the following risk factors-mild anaemia (Hb of 10-10.9 gm%), Rh negative blood group, induction of labour, previous 1 abortion, oligohydramnios which does not require amnioinfusion, polyhydramnios without any anomalies in the fetus, primary infertility, gestational diabetes on diet, obesity, hypothyroidism and short staure primi with height more than 145cm)
2:Women at 36-42 weeks of gestational age
3:Women between the age group of 19-32 years
4:Women who come with spontaneous labour
5:Women who deliver normally without the aid of any obstetric instruments
6:Women who deliver with a second degree perineal tear or episiotomy
7:Women who can read English, Tamil or Telugu.
For newborn
1:Newborn with apgar 9 and 10 at 1’ and 5’ respectively
|
|
| ExclusionCriteria |
| Details |
For woman
1:High risk primigravida women
2:Women on epidural anaesthesia or entonox
3:Women who develop any third stage complications that warrant emergency/ intensive care
For newborn
1:Newborns with any condition at birth that warrants examination by a neonatologist
2:Newborns with any congenital anomalies which interfere with breastfeeding
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| newborn breastfeeding behaviour |
newborn breastfeeding behaviour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of third stage of labour, blood loss during third and fourth stage of labour, pain perception during suturing, newborn thermoregulation |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2014 |
| 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="0"
Months="1"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized controlled trial to assess the effectiveness of immediate skin-to-skin contact vs conventional care on selected maternal and newborn outcomes among 100 low risk primigravida women and their newborns after normal delivery in labour room of Christian medical college, vellore for a period of 6 weeks. primary outcome is newborn breastfeeding behaviour and secondary outcomes are duration of third stage of labour, blood loss during third and fourth stage of labour, pain perception during perineal wound suturing and newborn thermoregulation. |