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

31 Jul 2021

The date of last modification

Jul 31, 2021



Application Summary


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


Trial Details


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


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


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


Final sample size


Date of first publication


Link to results


Brief summary of results