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Vaginal Dinoprostone insert versus Foley Catheter for Labour Indution

Comparative evaluation of intravaginal slow release dinoprostone insert vs transcervical foleys catheter for induction of labour, in patients with poor bishops score - a randomized control study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011574
Enrollment
174
Registered
2018-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients that has poor BISHOPs score for induction of labour

Interventions

Intervention1: DINOPROSTONE SLOW RELAESE INTRA VAGINAL INSERT: This is a kind of vaginal pessary (commonly known as propess or cervidil)which is thin transparent polymeric slab which is rectangular in

Sponsors

ESIC PGIMSR Model Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Maternal age greater than 18 years. 2 Singleton pregnancy 3 Cephalic presentation 4 Reactive FHR in live foetus 5 Intact membranes 6 No previous uterine surgery 7 Bishopâ??s score less than 6 8 Absence of contraindications to vaginal delivery 9 And where Induction of labour is required -Post-term pregnancy, mild pre-eclampsia,diabetes mellitus,intrauterine growth restriction,IHCP, chronic hypertension in mother,gestational hypertension.

Exclusion criteria

Exclusion criteria: 1 Previous uterine and cervical surgery 2 Estimated foetal weight greater than 4500 gms or less than 1500gms 3 Antepartum Haemorrhage 4 Cephalo-pelvic disproportion 5 Moderate to severe preeclampsia. 6 Glaucoma and increase intraocular pressure. 7 Any contraindications of prostaglandins. 8 Active genital herpes 9 Cancer cervix 10 Grand multipara (Parity greater than 4 ) 11 Malpresentation 12 Vaginal bleeding of anyetiology 13 Bronchial asthma 14 Pyrexia 15 Patients hypersensitive to prostaglandins.

Design outcomes

Primary

MeasureTime frame
1 Induction to active labour time. 2 Induction to delivery time (spontaneous vaginal, operative vaginal and caesarean delivery) Timepoint: 1 Induction to active labour time. 2 Induction to delivery time (spontaneous vaginal, operative vaginal and caesarean delivery)

Secondary

MeasureTime frame
1 Requirement of oxytocin 2 Mode of delivery 3 Abnormal CTG recordings 4 Uterine contraction abnormalities 5 Complications during labour 6 Apgar score being determined at 1 and 5 minutes, 7 Duration of stay in hospital was calculated. 8 Maternal complications- Nausea, Vomiting, Pyrexia, Intra partum temperature,PPH. Timepoint: 10 days

Countries

India

Contacts

Public ContactDr Ritu Singh

ESIC PGIMSR Model Hospital, Basaidarapur, New Delhi

tarugupta1971@yahoo.com9560321212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026