| CTRI Number |
CTRI/2019/08/020657 [Registered on: 09/08/2019] Trial Registered Prospectively |
| Last Modified On: |
07/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to see if discontinuation of oxytocin in active phase of induced labours has an effect on the maternal and fetal outcomes. |
|
Scientific Title of Study
|
: Randomised placebo controlled trial to compare maternal and fetal effects following discontinuation VERSUS continuation of oxytocin in active labour |
| Trial Acronym |
DOAL study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MRUDUL SHASHIKANT SHINGE |
| Designation |
PG REGISTRAR |
| Affiliation |
CMC, VELLORE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY (OG-4), CMCH, VELLORE-632004, TAMIL NADU, INDIA
ROOM NO 843, LADIES INTERNS QUARTERS, CMCH, VELLORE-632004, TAMIL NADU, INDIA
Vellore
TAMIL NADU
632004
India |
| Phone |
9822451887 |
| Fax |
|
| Email |
mrudul.shinge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANISHA MADHAI BECK |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE , VELLORE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY , UNIT 4,
CHRISTIAN MEDICAL COLLEGE, VELLORE
TAMIL NADU, INDIA 632004
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY , UNIT 4,
CHRISTIAN MEDICAL COLLEGE, VELLORE
TAMIL NADU, INDIA 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9787892640 |
| Fax |
|
| Email |
beckmanisha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MANISHA MADHAI BECK |
| Designation |
PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE , VELLORE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY , UNIT 4,
CHRISTIAN MEDICAL COLLEGE, VELLORE
TAMIL NADU, INDIA 632004
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY , UNIT 4,
CHRISTIAN MEDICAL COLLEGE, VELLORE
TAMIL NADU, INDIA 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9787892640 |
| Fax |
|
| Email |
beckmanisha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Fluid research grant
Christian Medical College and Hospital
Vellore, Tamil Nadu 632004 |
|
|
Primary Sponsor
|
| Name |
FLUID GRANT INSTITUTIONAL |
| Address |
CHRISTIAN MEDICAL COLLEGE, VELLORE, TAMIL NADU 632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mrudul Shinge |
CHRISTIAN MEDICAL COLLEGE |
Department of ObGyn, Unit 4
7th floor,Lift No 3, Ida Scudder Centenary building
Vellore
TAMIL NADU |
9822451887
mrudul.shinge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuation of oxytocin throughout labour |
Oxytocin will be continued till delivery. |
| Intervention |
Discontinuation of oxytocin in active stage of induced labours |
In Group 1 patients (Discontinuation/Intervention group), Oxytocin infusion will be discontinued in active stage of labour (cervical dilatation more than or equal to 5cm). In Group 1, after 4 hours of discontinuation, if the PV finding is the same, oxytocin will be restarted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women with singleton pregnancies undergoing labour induction at term |
|
| ExclusionCriteria |
| Details |
Multiple pregnancy
preterm
Previous LSCS
Severe pre eclampsia/gestational hypertension
abruption
meconium stained amniotic fluid
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall LSCS rate |
AT THE END OF THE PREGNANCY (37-41 WEEKS ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal:
Mean duration of labour, Number of women in Discontinuation group who were restarted back on Oxytocin,Number of women in Continuation group where oxytocin was stopped, Uterine hyperstimulation, Post-partum haemorrhage, Chorioamnionitis, Breast feeding
Fetal:
Intrapartum CTG abnormalities, APGAR score 7 at 5 mins, NICU admission |
AT THE END OF PREGNANCY (37-41 WEEKS) |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
15/08/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Induction of labour is a common obstetric procedure. It aims at stimulating labour using artificial methods with the aim to achieve delivery in women with complications such as hypertension , diabetes , fetal growth restriction etc. The most common pharmacological agent being used for this is oxytocin. While oxytocin is safe and effective in most cases, it may cause uterine hyperstimulation leading to fetal distress and warranting LSCS. Women with prolonged use of oxytocin also may sometimes have complications like post partum haemorrhage or chorioamnionitis. The aim of the study is compare the maternal and fetal outcomes in two groups of women who undergo induction of labour when they are managed with two different labour protocols. In Group I , oxytocin will be stopped once woman enters into active stage or when cervix is >5 cm dilated . Oxytocin will not be given till delivery unless the woman has slow progress in labour or fails to get regular uterine contractions In Group II, Oxytocin will be continued till delivery . Vaginal examinations will be done every four hours or earlier if there are cases of fetal distress .The primary outcome will be to compare LSCS rates in both groups. Our hypothesis is that there should be a decrease in LSCS rate by 10% in the intervention arm (Group 1) where oxytocin is being stopped iin active phase of induced labour. Secondary maternal outcomes will be to compare the duration of labour along with rates of postpartum haemorrhage ; uterine hyperstimulation; and chorioamnionitis. Neonatal outcomes will be to look at rates of fetal heart rate abnormalities as documented on CTG (cardiotocograph); ; Apgar score at 5mins; need for Neonatal Intensive care (NICU) admission
|