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Safety and effectiveness of dinoprostone vaginal gel in pregnant women.

Study for the safety and effectiveness of a commercial product of 2 mg dinoprostone vaginal gel in pregnant women.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201502187974N6
Enrollment
45
Registered
2015-03-14
Start date
2014-08-26
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Pregnancy, childbirth and the puerperium. The codes included in this chapter are to be used for conditions related to or aggravated by the pregnancy, childbirth or by the puerperium (maternal causes or obstetric causes)

Interventions

Dinoprostone 2mg vaginal gel (Glandin E2) inserted high into posterior fornix. dose repeated (if required and prescribed by doctor) after six hours of first dose..
Treatment - Drugs
Dinoprostone 2mg vaginal gel (Glandin E2) inserted high into posterior fornix. dose repeated (if required and prescribed by doctor) after six hours of first dose.

Sponsors

Nabiqasim Industries (Pvt) Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Pregnant women; scheduled for labor induction with 2mg Dinoprostone vaginal gel; bishop score less than or equal to 4. Exclusion criteria: Bishop score greater then 4.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Increase of 3 in bishop score. Timepoint: six hours and 12 hours after dosing. Method of measurement: Bishop scoring method.;Attainment of bishop score of 6 or more. Timepoint: six and 12 hours after dosing. Method of measurement: Bishop scoring method.;Vaginal delivery occurring within 12 hours of dosing. Timepoint: occurring within 12 hours of dosing. Method of measurement: subject monitoring.

Secondary

MeasureTime frame
Maternal adverse events. Timepoint: from dosing to delivery. Method of measurement: Patient monitoring.;Neonatal adverse events. Timepoint: just after birth at 1 & 5 minutes. Method of measurement: APGAR score.;Fetal Adverse events. Timepoint: two hours after dosing, at six & 12 hours after dosing (till baby is not delivered). Method of measurement: by measuring CTG.

Countries

Pakistan

Contacts

Public ContactSalman Rahim

Nabiqasim Industries (Pvt) Ltd.

salman.rahim@nabiqasim.com009221 32636313

Outcome results

None listed

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