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

Phase 4

Recruiting

Conditions: Induction of labour

Registration Number: SLCTR/2017/019

Lead Sponsor: Department of Obstetrics and Gynaecology Professorial Unit, Teaching Hospital Anradhapura

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time duration from IOL to birth in minutes, <br> [From the time of 1st PGE2 insertion to birth in minutes (or to decision taken as emergency cesarean section)<br>]<br>Rate of failed induction. [From the time of 1st PGE2 insertion to decision taken as failed induction (within 24 hours]<br>

Secondary Outcome Measures

Name	Time	Method
Oxytocin necessary for augmentation. [From onset of labour until birth.]<br>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]<br> Type of delivery [At time of delivery]<br>Total bleeding during delivery (visual assessment of a 10x10cm gauze towel) [At the end of the 3rd stage of laboour]<br>The incidence of maternal fever (>37.3°C) [4 hourly until completion of 24 hours following delivery.]<br>Perineal tear needing repair. [At time of delivery]<br>1st and 5th minute Apgar score of the neonate. [At time of delivery]<br> Need for Neonatal Intensive Care Unit admission [Within the 1st 24 hours of birth, and at discharge.]<br>