Home » Trials » SLCTR/2021/022
Oral misoprostol Vs intravaginal PGE2 (Dinoprostone) for pre-induction cervical ripening in women with uncomplicated, singleton, post dated pregnancies: a randomized controlled study
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SLCTR Registration Number
SLCTR/2021/022
Date of Registration
The date of last modification
Sep 08, 2023
Trial Status
Scientific Title of Trial
Oral misoprostol Vs intravaginal PGE2 (Dinoprostone) for pre-induction cervical ripening in women with uncomplicated, singleton, post dated pregnancies: a randomized controlled study
Public Title of Trial
Effectiveness and safety of oral misoprostol Vs intravaginal PGE2 (Dinoprostone) for pre-induction cervical ripening in women with uncomplicated, singleton, post dated pregnancies: a randomized controlled study.
Disease or Health Condition(s) Studied
Induction of labour
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness and safety of oral misoprostol Vs intravaginal PGE2 (Dinoprostone) for pre-induction cervical ripening
Universal Trial Number
U1111-1268-0568
Any other number(s) assigned to the trial and issuing authority
2019/P/032 (ERC: Faculty Of Medicine, University of Ruhuna
What is the research question being addressed?
Is misoprostol 50 µg 3 doses, 4 hours apart effective and safe compared to intravaginal PGE2(Dinoprostone) 3mg 2 doses, 8 hours apart for pre-induction cervical ripening in women with uncomplicated, singleton, post dated pregnancies?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: Study will be conducted in Obstetric ward, Teaching Hospital Anuradhapura. Method of Randomization: Pregnant women who are included in the study will be randomized into interventional(misoprostol) group and control(PGE2) group by using block randomization technique using computer generated random numbers.
Intervention: In the interventional group, oral misoprostol 50 microgram three doses will be given four hours apart at 7.30 am,11.30am and 3.30 pm. Modified Bishops Score (MBS) will be assessed at 8 hours and 24 hours. At the completion of 24 hours, assessment will be done at 7.30am by primary investigator.
Control: In the control group a 3mg tablet of PGE2 will be inserted into the posterior fornix of the vagina. Second dose will be inserted after 8 hours. MBS will be assessed at 8 hours and 24 hours.
Inclusion criteria
• Nulliparous pregnant women • In a singleton pregnancy • At 40 weeks and 5 days of gestation • Fetus in cephalic presentation with intact membranes • Modified bishop score(MBS) of < 5 • Not having any contraindications for vaginal delivery
Exclusion criteria
• past caesarian delivery • history of myomectomy • hypersensitivity to misoprostol • pregnancy induced hypertension • gestational diabetes mellitus • multiple pregnancies
Primary outcome(s)
|
1.
To compare the number of women who establish spontaneous onset of labor (SOL) |
[ Period of gestation - 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation ] |
|
2.
To compare the number of women who do not establish SOL ,but become favorable for induction of labor(IOL) with modified Bishops Score (MBS) ˃7. |
[ Period of gestation 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation ] |
|
3.
To compare the number of women who do not establish SOL and who are not favorable for IOL following 24 hours of the intervention. |
[ Period of gestation 40 weeks+6 days of gestation following the intervention at 40 weeks +5 days of gestation ] |
|
4.
To compare the intervention to delivery time in those who establishes SOL following interventions. |
[ Period of gestation 40 weeks+6 days ] |
Secondary outcome(s)
|
1.
To compare the number of women who needed emergency cesarean delivery following intervention and after going into vaginal delivery within 48 hours. |
[ Period of gestation 40 weeks+ 7 days ] |
|
2.
To compare the number of women who had pathological CTG required emergency cesarean delivery following intervention and after starting vaginal delivery after intervention. |
[ Period of gestation 40 weeks+ 7 days ] |
|
3.
To compare the maternal morbidity, number of patients with: • uterine hyperstimulation occurring within first 24 hours after intervention • requiring post partum blood transfusion due to post partum haemorrhage • with uterine rupture following intervention and during labour. |
[ Period of gestation 40 weeks+ 6 days ] |
|
4.
To compare the fetal and neonatal outcome and morbidity. • CTG considered to be Suspicious or Pathological as per FIGO Guidelines within first 24 hours following intervention • Presence of meconium stained liquor at the time of doing artificial rupture of membranes and delivery or detected during labour by vaginal examination • APGAR scores <5 at 1 minute after delivery • Admission to the PBU/NICU within first 24 hours after delivery and its reason |
[ Period of gestation 40 weeks+ 6 days ] |
Target number/sample size
250 (125 each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-08-01
Anticipated end date
2022-03-01
Date of first enrollment
2021-08-01
Date of study completion
2022-02-15
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2019-09-03
Approval number
2019/P/032
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Ruhuna. |
| Institutional Address: | P.O.Box 70,Galle, Sri Lanka |
| Telephone: | +94-91-2232288 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr.Y.N.Godakanda
Senior Registrar in Gynaecology and Obstertricss
Teaching Hospital Anuradhapura
0772341543
yasiru05@gmail.com
Contact Person for Public Queries
DR. M.F.M.Rameez
Senior Lecturer/Consultant Obstertrician and Gynaecologist
Teaching Hospital Mahamodara
0777900991
rameezfurukan@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
2022-02-15
Final sample size
Date of first publication
Link to results
Brief summary of results
