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Effect of vaginal PH on efficacy of controlled- release Dinoprostone vaginal insert for cervical ripening/ labor induction.

Effect of vaginal PH on efficacy of controlled- release Dinoprostone vaginal insert for cervical ripening/ labor induction.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138904091760N7
Enrollment
147
Registered
2010-06-30
Start date
2005-10-20
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

Labor Induction. Pregnancy, childbirth and the puerperium

Interventions

Vaginal tablets Dinoprostone (Containing 3 mg).
Treatment - Drugs
Vaginal tablets Dinoprostone (Containing 3 mg)

Sponsors

Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: women with age 16-35 years, nulligravida, single tone pregnancy, cephalic presentation, Bishop Score equal or less than 5, no contraindication for vaginal delivery, uterine contractions did not start. Exclusion criteria: known allergy to prostaglandins, membrane rupture, fetal infection, history of previous surgery on the uterus and the previous induction of labor in recent pregnancy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Cervix softening. Timepoint: After 12 hours of placing a vaginal suppository. Method of measurement: Bishop score.

Secondary

MeasureTime frame
Duration of the stages of labor. Timepoint: Intervals between each stage (Latent phase, the active phase and second stage of labor). Method of measurement: From time to start feeling regular contractions to dilatation 3-5 cm (Latent phase) / Dilatation from 3-5 cm to complete dilatation (active phase) / Since the complete withdrawal dilatation to fetus (Second stage of labor).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNargess Gholizadeh Pasha

Fatemehzahra Fertility & Reproductive Health Reseach Center

ngh_pa@yahoo.com , zahra@mubabol.ac.ir+98 11 1227 4881

Outcome results

None listed

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