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A clinical trail to study the efficacy and safety of two types of dinoprostone medication ( single application of slow release vaginal insert VS multiple dose gel) for labor initiation

A randomized control trial comparing efficacy and safety of controlled release dinoprostone vaginal insert and dinoprostone gel for labor induction

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043188
Enrollment
600
Registered
2022-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: controlled release dinoprostone vaginal insert (Propess): Propess is placed in the posterior fornix of the vagina with about 2 cm of the tape is left outside the vagina, the women is in

Sponsors

Sultan Qaboos University Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy Term pregnancy of 37 weeks or more Cephalic presentation Bishop score 6 or less, Intact or ruptured membranes. The following women will be excluded.

Exclusion criteria

Exclusion criteria: Previous scared uterus (cesarean section, extensive myomectomy involving the uterine cavity, previous uterine rupture or dehiscence), Para 4 or more, multiple pregnancy, estimated fetal weight more than 4 kilograms, abnormal CTG (cardiotocogram). Any contraindication for vaginal delivery (placenta previa, malpresentation, active genital herpes infection). Women with contraindication or hypersensitive to dinoprostone.

Design outcomes

Primary

MeasureTime frame
Primary outcome - Induction to vaginal delivery interval - Need for oxytocin to augment labour occurrence of hyper stimulation, non-reassuring CTG - Mode of delivery - APGAR score, cord pH & NICU admissions - Maternal morbidity during labour Sample size is calculated from previous 6 years data Timepoint: End point for cervical ripening are strong uterine contractions , bishop score 6. Induction of labour will be considered successful if vaginal delivery within 24 hours of induction.

Secondary

MeasureTime frame
Patient satisfaction (a scale of 100) after delivery. - Cost effective analysis of the two induction methods - Subgroup analysis based on the Bishop score and parity. Timepoint: till delivery

Countries

Oman

Contacts

Public ContactAttibele Manjunath Manjunatha

Sultan Qaboos University Hospital

manjunathattibele@gmail.com0096894422740

Outcome results

None listed

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