CTRI Number |
CTRI/2021/01/030348 [Registered on: 08/01/2021] Trial Registered Prospectively |
Last Modified On: |
07/01/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study comparing a drug causing labor pains when given orally vs vaginally in pregnant women |
Scientific Title of Study
|
A Randomised Controlled Trial Comparing Transcervical Foleys Catheter With Oral V/S Vaginal Misoprostol In Pregnant Women At Term For Induction Of Labor |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kanan Rambani |
Designation |
Junior Resident |
Affiliation |
DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH |
Address |
Department of obstetrics and Gynecology
DR.RPGMC KANGRA AT TANDA
Kangra HIMACHAL PRADESH 176001 India |
Phone |
7986488185 |
Fax |
|
Email |
Kananrambani@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Kanan Rambani |
Designation |
Junior Resident |
Affiliation |
DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH |
Address |
Department of obstetrics and Gynecology
DR.RPGMC KANGRA AT TANDA
Kangra HIMACHAL PRADESH 176001 India |
Phone |
7986488185 |
Fax |
|
Email |
Kananrambani@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr CD Sharma |
Designation |
Assistant Professor |
Affiliation |
DR.RPGMC, KANGRA AT TANDA HIMACHAL PRADESH |
Address |
Department of obstetrics and Gynecology
DR.RPGMC KANGRA AT TANDA
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9816326544 |
Fax |
|
Email |
cdsharma2006@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
DRRPGMC Kangra |
Address |
VPO Tanda Kangra Himachal Pradesh 176001 |
Type of Sponsor |
Government 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 Kanan Rambani |
Dr.RPGMC Tanda At Kangra |
Antenatal Ward,Department of Obstetrics and Gynecology Kangra HIMACHAL PRADESH |
7986488185
Kananrambani@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instituitional Ethics Committee Dr.RPGMC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
To Compare Oral Vs Vaginal Misoprostol Along With transcervical foleys catheter For induction of labor In Pregnant Women |
GROUP A will receive 25 micrograms misoprostol per vaginally which will be repeated every 4 hourly to a maximum of 5 doses or until they go into labor. |
Intervention |
To Compare Oral Vs Vaginal Misoprostol Along With transcervical foleys catheter For induction of labor In Pregnant Women |
All the women participating in the study will be inserted with transcervical foleys catheter inflated with 60cc balloon after which they will be randomized in the two groups.
GROUP A will receive 50 micrograms misoprostol orally which will be repeated every 4 hourly to a maximum of 5 doses or until they go into labor.
In both groups when the cervix will become favourable ie. Bishop score of 6 or the patient will be in active phase of labor (defined as cervical dilation of 3cm or more), misoprostol will be discontinued and further management will be decided as per standard labor room protocol (WHO partographic management).
Oxytocin infusion will be started in patients who have not developed adequate contractions. Monitoring will be employed in all patients and labor will be managed partographically.
If women do not go into active labor 4 hours after the fifth dose, artificial rupture of
membranes followed by oxytocin infusion will be done.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
1. fetal malpresentations
2. rupture of membranes/ pre-existing chorioamnionitis
3. previous uterine surgery( CS/ hysterotomy/ myomectomy/metroplasty)
4. multifetal gestation
5. antepartum bleeding
6. intrauterine fetal demise
7. Anencephaly
8. allergy to latex.
9. All contraindications to vaginal delivery (eg carcinoma cervix, structural pelvic abnormalities eg rachitic pelvis, Cephalopelvic disproportion.)
10. A previous attempted IOL during current pregnancy.
11. Placenta or vasa previa or cord presentation.
12. Active genital herpes.
13. Contraindications to prostaglandins (eg. Asthma, acute PID, hypersensitivity)
14. Any co-morbid surgical illness (eg. Pyelonephritis, etc)
15. Non reassuring fetal heart rate status.
|
|
ExclusionCriteria |
Details |
1. fetal malpresentations
2. rupture of membranes/ pre-existing chorioamnionitis
3. previous uterine surgery( CS/ hysterotomy/ myomectomy/metroplasty)
4. multifetal gestation
5. antepartum bleeding
6. intrauterine fetal demise
7. Anencephaly
8. allergy to latex.
9. All contraindications to vaginal delivery (eg carcinoma cervix, structural pelvic abnormalities eg rachitic pelvis, Cephalopelvic disproportion.)
10. A previous attempted IOL during current pregnancy.
11. Placenta or vasa previa or cord presentation.
12. Active genital herpes.
13. Contraindications to prostaglandins (eg. Asthma, acute PID, hypersensitivity)
14. Any co-morbid surgical illness (eg. Pyelonephritis, etc)
15. Non reassuring fetal heart rate status.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To measure induction-delivery interval. |
At the time of delivery (O HOURS- SINGLE OBSERVATION AT BASELINE) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration from IOL to active phase of labor ( defined as ≥ three or more painful contractions in 10 minutes, 80% or greater effacement or cervical dilation of more than 3 cm). |
As mentioned above. |
delivery rates |
Within 12 and 24 hours of induction of labor |
Proportion of women undergoing CS in both groups. |
after delivery of the woman. |
Incidence of failure of Induction. |
4 hours post 5th dose of misoprostol. |
• Incidence of hyperstimulation in two groups ( hyperstimulation defined as a single contraction lasting for more than 2 minutes or 5 or more contractions in 10 minutes with fetal heart rate changes) |
not applicable |
Meconium stained liquor. |
not applicable |
Incidence of chorioamnionitis ( defined as maternal temperature of more than 38 Celsius during and after labor). |
during and post 48 hours of delivery |
Neonatal outcomes including: Apgar score (1 min & 5 min),Need of phototherapy (if required; duration),Intensive care admission (if required)
|
After delivery |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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
|
N/A |
Date of First Enrollment (India)
|
14/01/2021 |
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="0" 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
|
Induction of labor (IOL) implies stimulation of contractions before the spontaneous onset of labor, with or without ruptured membranes. It is an intervention designed for iatrogenic ripening of cervix and to initiate uterine contractions leading to progressive dilatation and effacement of cervix resulting into birth of the newborn. It is indicated only when the risks of continuing pregnancy outweigh the benefits to the mother and the fetus. Methods of IOL presently in use include various mechanical, pharmacological or a combination of mechanical and pharmacological. Mechanical methods include use of various agents such as transcervical folleys catheter(TCFC) inflated with various amounts of fluid, laminaria tents, synthetic osmotic dilators etc. TCFC is cheap, readily available and easy to use and moreover less painful alternative which affects changes on various components of the bishop score and does not cause overstimulation of the uterus and does not increase the risk of rupture or intrauterine infection and does not adversely affect the fetus and newborn. However its potential side effects include premature rupture of membranes, chorioamnionitis, bleeding, displacement of presenting part and futire risk of preterm bith. Pharmacological methods of IOL include agents such as oxytocin, prostaglandins, relaxin, nitic oxide donors such as isosorbide mononitrate, mifepristone etc out of which prostaglandins are the most widely used agents which include various sub classes such as PGE1 ie. Misoprostol and PGE2 known commonly as dinoprostone which is being used as gel and tablet, has the advantage of being used intracervical or vaginally but is expensive and needs refrigeration. Misoprostol originally used as gastroprotective agent , has advantage of being cheap, stable at room temperature and easy to be administered by various routes i.e. vaginal, oral, sublingual or rectal where the former two routes of administration are most commonly used . Absorption by oral route is more rapid than vaginally administered misoprostol reaching peak serum concentrations within 30 min compared to one hour with vaginal route. Oral misoprostol is eliminated rapidly (2–3 h) than vaginal (>=4 h). In 2014, a Cochrane review on the use of orally administered misoprostol for IOL suggested that vaginal misoprostol was less effective than oral misoprostol at achieving vaginal birth, with an increased risk of uterine tachysystole and CS with vaginal misoprostol Nowadays, a combination approach using pharmacological and mechanical methods is followed for IOL. Whereas misoprostol is more effective in improving the scores of cervical length and consistency, TCFC is better at improving the cervical dilatation score at pre-induction cervical ripening; thus, both improve different parameters. Both oral and vaginal routes of misoprostol for IOL have its merits and demerits and its efficacy and safety as an adjunct with TCFC has not been widely studied. IOL may lead to longer lengths of stay, increased hospital costs and increased newborn and maternal morbidities. In order to mitigate these risks, it is important to choose methods of IOL which are safe and efficacious in achieving a vaginal delivery. Hence, we plan to compare TCFC with oral vs vaginal misoprostol as an adjunct for IOL in pregnant women at term. |