| CTRI Number |
CTRI/2021/09/036921 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/12/2022 |
| 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 clinical trial to compare the concurrent use of vaginal misoprostol and transcervical foley catheter inflated with 60 ml vs 80 mlin nulliparous women at term for induction of labor |
|
Scientific Title of Study
|
A randomized controlled trial to compare concurrent use of vaginal misoprostol and transcervical foley catheter inflated with 60 mL vs 80 mL in nulliparous pregnant women at term for induction of labor |
| Trial Acronym |
FC8060 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Jaryal |
| Designation |
Junior resident |
| Affiliation |
Dr R.P.G.M.C Tanda at Kangra |
| Address |
Department of obstetrics and gynecology
Dr R.P.G.M.C Kangra at Tanda
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
8894219268 |
| Fax |
|
| Email |
sakshijaryal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakshi Jaryal |
| Designation |
Junior Resident |
| Affiliation |
Dr R.P.G.M.C Tanda at Kangra |
| Address |
Department of obstetrics and gynecology
Dr R.P.G.M.C Kangra at Tanda
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
8894219268 |
| Fax |
|
| Email |
sakshijaryal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C D Sharma |
| Designation |
Associate professor |
| Affiliation |
Dr R.P.G.M.C Tanda at Kangra |
| Address |
Department of obstetrics and gynecology
Dr R.P.G.M.C Kangra at Tanda
Kangra
HIMACHAL PRADESH
176002
India |
| Phone |
9816326544 |
| Fax |
|
| Email |
cdsharma2006@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr RPGMC 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 |
| sakshi jaryal |
Antenatal ward Department of obstetrics and gynecology |
Dr R.P.G.M.C Kangra at Tanda
Kangra
HIMACHAL PRADESH |
8894219268
sakshijaryal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Dr RPGMC Tanda |
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 concurrent use of vaginal misoprostol and TCFC inflated with 60 mLvs 80mL in nulliparous pregnant women at term for induction of labor |
Group A will be inserted with TCFC 60 mL and concurrently vaginal misoprostol 25 microgram will be given (max 5 doses)or until they go into labour |
| Intervention |
To compare concurrent use of vaginal misoprostol and TCFC with 60 mL vs 80 mL in nulliparous pregnant women at term |
All the women participating in study will be receiving 25 microgram vaginal mosoprostol (max 5 doses)after which they will be randomised into two groups. Group A will be inserted with TCFC 60 cc and group B will be inserted with TCFC 80cc. In both groups when cervix will become favourable ie. Bishop score of 6 or pattient will be in active phase of labor (defined as cervical dilatation greater than equal to 4cm) and further management will be done as per labor room protocol.
thus different volume of TCFC will be compared to know the difference in induction delivery interval and if higher volume results in more favourable bishop score or not |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Single live intrauterine fetus with cephalic presentation
period of gestationgreater than equal to 40 weeks |
|
| ExclusionCriteria |
| Details |
women in spontaneous labor
fetal malpresentation
rupture of membranes
previous uterine surgery
multifetal gestation
antepartum haemorrhage
all contraindications to vaginal delivery(rachitic elvis, carcinoma cervix,CPD)
Intruterine fetal death
allergy to latex
placenta vasa previa or cord presentation
active genital herpes
contraindications to prostaglandins
any co morbid surgical illness
Non reassuring fetal heart rate
any previous attempt of IOLin present pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Induction delivery interval (defined as time from TCFC insertion to delivery of fetus) |
Induction delivery interval (defined as time from TCFC insertion to delivery of fetus) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration from IOL to active labour |
as mentioned above |
| duration of labor(defined as time from start of active phase until delivery of fetus |
as mentioned above |
| proportion of women delivered vaginally |
withi 12 to 24 hours of induction of labor |
Proportion women undergoing CS
|
after delivery of women |
| proportion of women with failure of IOL |
if there is no contraction or Bishop score less than 6 even after 5 doses of misoprostol |
| Time period between insertion of TCFC and spontaneous expulsion of TCFC |
maximum 12 hours after insrtion of TCFC after which it shall be removed |
incidence of chorioamniontis
|
during and post 48 hours of delivery |
| meconium stained liquor |
not applicable |
| incidence of hyperstimulation |
not applicable |
neonatal outcomes(apgar score at 1 min and 5 min)
neonatal intensive care admission |
after delivery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2021 |
| Date of Study Completion (India) |
01/09/2022 |
| Date of First Enrollment (Global) |
30/09/2022 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 uterine contractions before the spontaneous onset of labor, with or without ruptured membranes.1 It is an intervention designed for iatrogenic ripening of cervix and to initiate uterine contractions leading to progressive dilatation and effacement of cervix resulting in birth of the newborn. The goal of IOL is to achieve a successful vaginal delivery with minimal maternal and fetal complications. Cervical ripening is an important factor for a successful IOL. Unripe cervix with a lower Bishop score is associated with an increased risk of failure of IOL, while a favorable cervix signiï¬cantly predicts a timely delivery. There are two main methods of cervical ripening. One is mechanical, including (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent, into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space. Transcervical foley’s catheter (TCFC) is cheap, easy to use, readily available, relatively painless and reversible method for IOL. The other method is pharmacological. Pharmacological methods include many agents, such as prostaglandins (PG) such as misoprostol i.e. PGE1 and dinoprostone i.e. PGE2 , progesterone receptor antagonists (mifepristone), oxytocin, and nitric oxide (NO) donors, but the most commonly used are prostaglandins and oxytocin. although the best agent and method for IOL remains uncertain, it is biologically plausible that a combination of a mechanical device (TCFC) and mechanical agent (misoprostol) may have a synergistic effect, resulting in a greater degree of cervical ripening and shorter induction to delivery time with concomitant reduction of side effects of each.In an attempt to raise the bishop score at a faster rate and decrease the time to delivery, TCFC are often overinflated or TCFC that accept larger volumes are used.13 The likelihood of vaginal delivery is correlated with a higher Bishop score at the time of induction, hence it is postulated that a higher volume TCFC used for cervical ripening will be associated with a higher bishop score which will further lead to higher rate of vaginal delivery.14 Hence, we plan to compare variable volumes of inflation of TCFC as an adjunct for IOL in pregnant nulliparous women at term.
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