CTRI Number |
CTRI/2019/09/021130 [Registered on: 09/09/2019] Trial Registered Prospectively |
Last Modified On: |
15/08/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
"SAFETY AND EFFICACY OF ORAL AND VAGINAL MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIESâ€- A RANDOMISED CONTROLLED TRIAL IN A TERTIARY HEALTH CENTRE |
Scientific Title of Study
|
"SAFETY AND EFFICACY OF ORAL V/S VAGINALLY ADMINISTERED MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIESâ€- A RANDOMISED 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 |
DRRESHMA RAJENDRAN |
Designation |
post graduate resident |
Affiliation |
MOSC MEDICAL COLLEGE |
Address |
MOSC MEDICAL COLLEGE
KOLENCHERY
KERALA
682311
Ernakulam KERALA 682311 India |
Phone |
9995782050 |
Fax |
|
Email |
dr.reshmaraj22@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DRANNIE SOMAN |
Designation |
HEAD OF DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY |
Affiliation |
MOSC MEDICAL COLLEGE |
Address |
MOSC MEDICAL COLLEGE
KOLENCHERY
KERALA
682311
Ernakulam KERALA 682311 India |
Phone |
9995782050 |
Fax |
|
Email |
aniesoman@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DRRESHMA RAJENDRAN |
Designation |
post graduate resident |
Affiliation |
MOSC MEDICAL COLLEGE |
Address |
MOSC MEDICAL COLLEGE
KOLENCHERY
KERALA
682311
Ernakulam KERALA 682311 India |
Phone |
9995782050 |
Fax |
|
Email |
dr.reshmaraj22@gmail.com |
|
Source of Monetary or Material Support
|
in patient and out patients,
Mosc medical college
Kolenchery |
|
Primary Sponsor
|
Name |
MOSC MEDICAL COLLEGEKOLENCHERY |
Address |
MOSC MEDICAL COLLEGE,KOLENCHERY
682311 |
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 |
Dhanya paul |
malankara orthodox syrian church medical college,kolenchery |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
HOSPITAL COMPLEX
MOSC MEDICAL COLLEGE,
KOLENCHERRY
682311 Ernakulam KERALA |
9495510265
dhanyapaulmary@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MOSC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O481||Prolonged pregnancy, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
ORAL MISOPROSTOL |
25mcg Q2h x total 5 doses for 1 day
SAFETY AND EFFICACY OF ORAL AND VAGINALLY ADMINISTERED MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIES |
Comparator Agent |
VAGINAL MISORPOSTOL |
25mcg Q4h x total 4 doses x 1 day
SAFETY AND EFFICACY OF ORAL AND VAGINALLY ADMINISTERED MISOPROSTOL FOR INDUCTION OF LABOUR IN TERM PREGNANCIES |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
Nulliparous and Multiparous women at term(37-42 completed weeks of gestation with first trimester ultrasound confirmed dates),with a singleton fetus of Cephalic presentation with :
Clinically adequate pelvis
Reassuring fetal heart tracing,
,Modified bishop’s score of less than 6
[1]Gestational diabetes mellitus,
[2] gestational hypertension,
[3]past date,
[4]oligohydramnios,
[5]Premature rupture of membranes[<6hours]
Are eligible for this trial |
|
ExclusionCriteria |
Details |
All patients with [1]severe systemic illnesses like uncontrolled diabetes mellitus, severe pre-eclampsia, cardiac, renal or hepatic disease,
[2] IUGR,
[3]intrauterine deaths
[4]hypersensitivity to misoprostol or any prostaglandin analogue
[5] Patients with any contraindication to induction and vaginal delivery, e.g. cephalopelvic disproportion, malpresentation, fetal compromise, non reassuring fetal heart rate pattern, previous scar and ante partum haemorrhage.
[6] Patients who are not willing to participate in this study |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Outcome variables. - Primary Caesarean for fetal distress, |
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Induction delivery interval
Maternal and perinatal outcome |
2weeks |
|
Target Sample Size
|
Total Sample Size="154" Sample Size from India="154"
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 2 |
Date of First Enrollment (India)
|
19/09/2019 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NONE YET |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Induction of labour implies stimulation of contractions before the spontaneous onset of labour, with or without ruptured membranes.[1].According to ACOG 2014[2],the risks and benefits of induction of labour were studied on caesarean section rate and trials showed no significant difference .Recent studies[3]- variation .i.e oral misoprostol for induction has comparatively decreased the incidence of Primary caesarean section for fetal distress. Primary caesarean which is a caesarean section done for the first time in pregnant woman. Prostaglandins has been found to have a major role in cervical ripening and making it favourable for a vaginal delivery. Among them, Misoprostol [Synthetic PGE1 analogue] is commonly used. It is Stable at room temperature, Relatively inexpensive ,can be given via several routes -oral, vaginal, sublingual ,buccal, rectal. Misoprostol has a potential risk for hyperstimulation, which is defined as occurrence of uterine contraction lasting for >60secs ,OR >4 contractions in a 10 minute period regardless the state of the fetus. Therefore, it is necessary to be administered in titrated doses so that the risk can be reduced .This is the reason for inclusion of oral misoprostol as one of the recommended induction agents in the WHO EXPERT committee-Labour guidelines in 2011. |