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Comparison of vaginal prostaglandin E2 gel and tablets for the induction of labor at term: a randomized controlled trial. -

SLCTR Registration Number

SLCTR/2017/019


Date of Registration

05 Jul 2017

The date of last modification

Jul 24, 2017



Application Summary


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 of Health Condition(s) Studied

Induction of labour


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1197-0592


Any other number(s) assigned to the trial and issuing authority

EC/2017/10 (ERC: Rajarata University)


Trial Details


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


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

  1. Pregnant women undergoing elective induction of labour.

  2. Period of gestation between 37 completed weeks to 41 completed weeks

  3. Singleton pregnancy

  4. Cephalic presentation


Exclusion criteria

  1. ‘Favorable’ cervix (Bishop score of >6)

  2. Any contraindication to vaginal delivery (previous uterine surgery including caesarean section and myomectomy, major degree placenta previa, cephalopelvic disproportion)

  3. Abnormal cardiotogography (CTG) or known fetal compromise

  4. Persisting maternal temperature (>37.3 degrees Celsius for when measured 4 hourly for 24 hours)

  5. Spontaneous labour

  6. Malpresentation.

  7. Large baby on clinical examination (estimated fetal weight >4.5 kg)

  8. Dribbling with unfavorable cervix.

  9. Known allergy to PGE2.

  10. Diagnosed mental illness

  11. 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,
  2. Rate of failed induction.

Primary outcome(s) - Time of assessment(s)

Time duration of IOL: from the time of 1st PGE2 insertion to birth in minutes (or to decision taken as emergency cesarean section)

Failed induction: from the time of 1st PGE2 insertion to decision taken as failed induction (within 24 hours)


Secondary outcome

  1. Oxytocin necessary for augmentation.
  2. Uterine hyper stimulation (uterine contractions more than 4 per 10 minutes as assessed by CTG)
  3. Type of delivery
  4. Total bleeding during delivery (visual assessment of a 10x10cm gauze towel)
  5. The incidence of maternal fever (>37.3°C)
  6. Perineal tear needing repair.
  7. 1st and 5th minute Apgar score of the neonate.
  8. Need for Neonatal Intensive Care Unit admission

Secondary outcome(s) - Time of assessment(s)

  1. Oxytocin necessary for augmentation.
  2. Uterine hyper stimulation (uterine contractions more than 4 per 10 minutes as assessed by CTG)
  3. Type of delivery
  4. Total bleeding during delivery (visual assessment of a 10x10cm gauze towel)
  5. The incidence of maternal fever (>37.3°C)
  6. Perineal tear needing repair.
  7. 1st and 5th minute Apgar score of the neonate.
  8. Need for Neonatal Intensive Care Unit admission


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


Recruitment status

Recruiting


State of ethics review approval

Approved by Ethics Review Committee, Faculty of Medicine and Allied Sciences (FMAS), Rajarata University of Sri Lanka(RUSL) on 14th March 2017 (Ref: EC/2017/10)


Funding source

None (investigator funded)



Contact & Sponsor Information


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.


Primary study sponsor/organization

Department of Obstetrics and Gynaecology Professorial Unit, Teaching Hospital Anradhapura

Harischandra Mawatha, Anuradhapura Sri Lanka
Tel: 025-2 222261


Secondary study sponsor (If any)

None