Home » Trials » SLCTR/2017/019
Comparison of vaginal prostaglandin E2 gel and tablets for the induction of labor at term: a randomized controlled trial.
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SLCTR Registration Number
SLCTR/2017/019
Date of Registration
The date of last modification
Apr 30, 2019
Scientific Title of Trial
Comparison of vaginal prostaglandin E2 gel and tablets for the induction of labor at term: a randomized controlled trial.
Public Title of Trial
Comparison of vaginal prostaglandin E2 gel and tablets for the induction of labor at term: a randomized controlled trial.
Disease or Health Condition(s) Studied
Induction of labour
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1197-0592
Any other number(s) assigned to the trial and issuing authority
EC/2017/10 (ERC: Rajarata University)
What is the research question being addressed?
Does induction of labour by vaginal prostaglandin E2 gel, reduce the induction of labour (IOL) to birth interval and the rate of failed IOL when compared to vaginal prostaglandin E2 tablets in pregnant women with an unfavorable cervix, who have completed 37 weeks of gestation?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study will be conducted at Ward 65, Teaching Hospital Anuradhapura. Simple (primiparous / multiparous) block randomisation, using computer generated random numbers will be used to allocate participants into two arms.
Arm 1 will receive prostaglandin E2 (PGE2) tablet 3mg, inserted vaginally, up to a maximum of 3 doses, 6 hours apart.
Arm 2 will receive PGE2 gel 2mg inserted vaginally. A maximum of 3 doses will be administered 6 hours apart. For primiparous women, 1st dose of gel is 2mg and 2nd and 3rd dose will be 1mg. For multiparous women all 3 doses are 1mg.
If cervical assessment indicates a favorable cervix (modified bishop score >6), the next dose(s) will not be administered in either arm.
Management of labour and any complications such as allergic reactions, uterine hyper-stimulation, fetal distress, post-partum hemorrhage and perineal tears will be manage according to standard labour ward protocols.
Participants and data analysts will be blinded to the intervention status.
Inclusion criteria
Pregnant women undergoing elective induction of labour.
Period of gestation between 37 completed weeks to 41 completed weeks
Singleton pregnancy
Cephalic presentation
Exclusion criteria
‘Favorable’ cervix (Bishop score of >6)
Any contraindication to vaginal delivery (previous uterine surgery including caesarean section and myomectomy, major degree placenta previa, cephalopelvic disproportion)
Abnormal cardiotogography (CTG) or known fetal compromise
Persisting maternal temperature (>37.3 degrees Celsius for when measured 4 hourly for 24 hours)
Spontaneous labour
Malpresentation.
Large baby on clinical examination (estimated fetal weight >4.5 kg)
Dribbling with unfavorable cervix.
Known allergy to PGE2.
Diagnosed mental illness
Physical conditions that would complicate or interfere with normal labour (pelvic bone fracture, femur fracture, lower limb disability, upper limb disability or any condition that would reduce the ability to bear down (strain) during labour.
Primary outcome(s)
|
1.
Time duration from IOL to birth in minutes, |
[ From the time of 1st PGE2 insertion to birth in minutes (or to decision taken as emergency cesarean section) ] |
|
2.
Rate of failed induction. |
[ From the time of 1st PGE2 insertion to decision taken as failed induction (within 24 hours ] |
Secondary outcome(s)
|
1.
Oxytocin necessary for augmentation. |
[ From onset of labour until birth. ] |
|
2.
Uterine hyper stimulation (uterine contractions more than 4 per 10 minutes as assessed by CTG) |
[ Uterine contractions more than 4 per 10 minutes as assessed using intermittent cardiotocography during the first stage of labour and continuous cardiotocography during the second stage of labour, until birth ] |
|
3.
Type of delivery |
[ At time of delivery ] |
|
4.
Total bleeding during delivery (visual assessment of a 10x10cm gauze towel) |
[ At the end of the 3rd stage of laboour ] |
|
5.
The incidence of maternal fever (>37.3°C) |
[ 4 hourly until completion of 24 hours following delivery. ] |
|
6.
Perineal tear needing repair. |
[ At time of delivery ] |
|
7.
1st and 5th minute Apgar score of the neonate. |
[ At time of delivery ] |
|
8.
Need for Neonatal Intensive Care Unit admission |
[ Within the 1st 24 hours of birth, and at discharge. ] |
Target number/sample size
211 (106 in the intervention arm and 105 in the control arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-07-03
Anticipated end date
2017-11-03
Date of first enrollment
2017-07-15
Date of study completion
Recruitment status
Recruiting
Funding source
None (investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-03-14
Approval number
EC/2017/10
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. |
| Institutional Address: | 2nd Floor, Para-clinical Building Faculty of Medicine and Allied Sciences Rajarata University of Sri Lanka Saliyapura, Sri Lanka |
| Telephone: | +94 252053633 |
| Email: | ethicsreviewcommittee@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Kopalapillai vasantharajah
Registrar in Obstetrics and Gynaecology
Professorial Obstetrics and Gynaecology Unit, Teaching Hospital Anradhapura
Sri Lanka.
Mob: 0772988875
kvasantharajah12@gmail.com
Contact Person for Public Queries
Dr. D.M.A. Kumara
Consultant Obstetrician and Gynaecologist/Senior Lecturer
Department of Obstetrics and Gynaecology
Professorial Unit, Teaching Hospital Anradhapura and Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka.
Mob: 0773995782, 0712962245
kumaradissanayake@hotmail.com.
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
