Comparative study of Dinoprostone vaginal insert and oral misoprostol for Induction of labour
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Obstetrical outcome:
Study Overview
Brief Summary
Eligible pregnant women >37weeks are recruited in the study. Dinoprostone vaginal insert and Oral Misoprostol both are used as a standard of care and are used routinely for induction of labour in labour ward. Choice of drug for Induction of labour is provided to the patient. Patient will decide the method of induction.If patient is unable to decide,unit consultant will decide the method of induction. Participitants are recruited to the study based on inclusion criteria. All eligible women who are planned for Induction of labour with either of the drug can be recruited into the study. Women are advised in-patient admission prior to induction. Informed consent will be taken before induction.Pre-induction Cardiotocography will be done. In case of, Dinoprostone vaginal insert, it is kept in posterior fornix of cervix and patient is asked to lie down for 2 hours. Dinoprostone vaginal insert can be left for 24 hours and watched for progress .In Women receiving oral misoprostol , a dose of 25mcg will be given ,which will be repeated to a maximum of six doses if required. Misoprostol 25 μg tablets will be mixed in 25 mL of water and given orally every 2 hours .Per-vaginal examination to assess Bishop’s score will be done. Misoprostol will be administered until cervical dilatation of > 3cm or adequate uterine contractions ( 3 to 4 contractions lasting for 45 seconds in a period of 10 minutes).Strict feto-maternal surveillance done with Cardiotocography at regular intervals.In either of the methods of induction,Artificial rupture of membranes will be done if cervical dilatation >4cm . Intravenous oxytocin infusion augmentation will be commenced in cases with infrequent uterine contractions. Oxytocin infusion will be started at least 4 hours after misoprostol and was given for a maximum of 8 h. In women those, who did not progress with oral misoprostol ,option for re-induction with Dinoprostone intracervical gel 0.5mg is provided to the patient. Dinoprostone intracervical gel is used every 6th hourly the next day following oral Misoprostol. Dinoprostone gel is kept 80% intracervically and 20% in posterior fornix and watched for progress. The main outcome measure is the induction to delivery interval in those delivering vaginally. Secondary outcome measures included the number of doses of misoprostol, operative delivery rates, incidence of side effects and neonatal outcome
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Cephalic presentation normal fetal heart rate bishop score less than 4 Singleton pregnancy gestational age greater than 37weeks.
Exclusion Criteria
- •Previous Caesarean section previous uterine surgery Abnormal presentations estimated fetal weight greater than 4000grams Hypersensitivity to dinoprostone.
Outcomes
Primary Outcomes
Obstetrical outcome:
Time Frame: During the time of delivery.At term i.e greater than 37weeks of period of gestation
mode of delivery,induction to delivery time interval,Caesarean section rate
Time Frame: During the time of delivery.At term i.e greater than 37weeks of period of gestation
Secondary Outcomes
- APGAR score, NICU stays and other neonatal complications(At time of delivery)
Investigators
Naga Manikya Veena G
Kasturba Medical college,Manipal
