| CTRI Number |
CTRI/2021/04/033187 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
28/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
early inducing labour in women whose amniotic fluid leaked before the on set of labour vs waiting for some time and induction of labour, because that waiting period there is chance to progress spontaneously
here oral misoprostol tablet is used for inducing
|
|
Scientific Title of Study
|
Early vs late induction with oral misoprostol in pre labour rupture of membranes: A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yangala Sudha Devi |
| Designation |
Junior resident (academic) |
| Affiliation |
AIIMS |
| Address |
Obstetrics and Gynaecology
AIIMS,
Bhubaneswar
Obstetrics and gynaecology
AIIMS,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9440270624 |
| Fax |
|
| Email |
yangalasudhareddy321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepthy Balakrishnan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9446439373 |
| Fax |
|
| Email |
balakrishnandeepthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepthy Balakrishnan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,
AIIMS,
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9446439373 |
| Fax |
|
| Email |
balakrishnandeepthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and gynaecology,AIIMS Bhubaneswar, khordha, odisa |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS,Bhubaneswar, khordha |
| 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 Deepthy Balakrishnan |
AIIMS Bhubaneswar |
Obstetrics and gynaecology, AIIMS Bhubaneswar, khordha, odisa
Khordha
ORISSA |
9446439373
balakrishnandeepthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHUBANESWAR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral misoprostol |
12hr observation after Pre labour rupture of membranes group act as controls |
| Intervention |
oral misoprostol |
Group A: Whenever a Term PROM patient with leaking PV for less than 6 hours , with BISHOP score Less than 6 is admitted in the hospital, she will be induced with oral misoprostol 50microgms (1st dose) followed by (2nd dose) 50microgms after 4hours. Four hours after the second dose, the patient is reassessed. If BISHOP score is less than 6, we will give a 3rd dose of oral misoprostol 50microgms. After 6hours, if there are no contractions, we will augment with oxytocin for 4hours. Cesarean section will be done if there is no progress of labour, failed induction or other obstetric indication. If modified BISHOP score greater than 6 at the time of assessment after 2nd dose of misoprostol 50microgms, we will wait for 2 hours for spontaneous contractions, failing which we will start oxytocin for 4 hours. If not progressing a decision is to be taken for caesarean section.
Group B: In this group, we will keep patients under conservative management for 12hours after the onset of leaking. After 12hours, if modified BISHOP score less than 6 we induce with oral misoprostol 50microgms and if modified BSHOP score greater than 6 with no contractions, we augment with oxytocin for 4hours, if no progress, we will deliver by cesarean section. During this period, if patient develops fever, any maternal or fetal deterioration, then pregnancy will be terminated by cesarean section.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with gestational age greater than or equal to 37weeks to 42weeks,membranes ruptured, modified BISHOP score<6,Live fetus, singleton pregnancy, cephalic presentation. |
|
| ExclusionCriteria |
| Details |
premature prelabour rupture of membranes, multifetal gestation, non cephalic presentation, previous uterine scar and uterine rupture, antepartum hemorrhage, fetal anomalies, active genital herpes, pelvic structural deformities associated with cephalopelvic disproportions, invasive cervical carcinoma, previous pelvic surgeries |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the induction to delivery interval in both groups
12-24 hours |
To compare the induction to delivery interval in both groups
12-24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare the mode of delivery in both the groups.
to compare fetal and maternal outcomes
|
rupture of membranes, time of delivery and postnatal period in mother and neonatal period in baby |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre labour rupture of membranes (PROM)
is defined
as rupture of
membranes before the onset of labour. It occurs in about 8% of total
pregnancies and generally is followed by prompt onset of spontaneous labour and
delivery. A delay in the onset of
labour leads to an increased risk of maternal and neonatal infections.
The American College of Obstetrics and Gynaecology
recommended induction of labour over expectant management as a management of Term
PROM).
But any method of induction or
intervention have their own
complications. Many studies showed that 60-70% of term PROM cases go into
spontaneous labour within 24hrs, So we can wait for short period like 12hrs
because chance of progression in to spontaneous labour with less chance of
maternal and neonatal infections.
There
are two major methods for induction labour with unripe cervix. Mechanical
intervention and pharmacological agents, pharmacological methods of induction
includes prostaglandins and oxytocin. Prostaglandins are one of the preffered method of
cervical ripening and includes agents like misoprostol and dinoprostone but
vaginal misoprostol and dinoprostone have increased chance of wash out and
chance of introducing infection, Dinoprostone (PGE2) is expensive and unstable
at room temperature. Hence oral misoprostol is theoretically better due to
reduced need for a vaginal intervention,
easy availability and as it is stable at room temperature.primary aim is to know the induction to delivery interval in both early induction and late induction groups sample size 80 including drop outs study not yet started |