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Two methods of cervical preparation in first-trimester pregnant women

Comparison of the Effectiveness of Double Balloon Cervical Catheter and Oral Misoprostol on Cervical Ripening in Primigravida Women"

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260206068776N1
Enrollment
62
Registered
2026-03-17
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Delivery. Encounter for full-term uncomplicated delivery

Interventions

Intervention 1: Intervention group: In the double-balloon cervical catheter group, the catheter will be inserted under completely sterile conditions and only by an obstetrician-gynecologist. The inner

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Primiparous women Age range 18 to 45 years Weeks 37 to 42 of pregnancy (more than 37 weeks of pregnancy, but less than 42 weeks) A Bishop score of less than 6 is considered an inclusion criterion for most studies on cervical preparation

Exclusion criteria

Exclusion criteria: A history of cervical surgery or anatomical abnormalities in the cervical area Emergency cesarean section: In case of an urgent need for a cesarean section due to unforeseen medical problems Serious complications: If any serious complications occur, including severe bleeding, infection, or medication side effects Non-compliance with the protocol: failure to follow treatment instructions or inability to complete all study steps. Participant withdrawal: Withdrawal from the study at any stage. Inability to read and understand the informed consent form and agreement to participate in the study The presence of any underlying medical conditions, including heart disease, kidney disease, diabetes, or hematological disorders Heart valve disease and history of seizures Absence of infection in the vaginal area according to a gynecologist's examination

Design outcomes

Primary

MeasureTime frame
The time it takes for the cervix to become ready until the Bishop score is greater than 6. Timepoint: Every 4 hours. Method of measurement: Vaginal examination.

Secondary

MeasureTime frame
Type of delivery. Timepoint: After giving birth. Method of measurement: File.;Cause of cesarean delivery. Timepoint: After giving birth. Method of measurement: File.;Uterine tachysystole. Timepoint: During labor. Method of measurement: Tocography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Farahnaz Changai

Khoram-Abad University of Medical Sciences

Farahnazchangavi@yahoo.com+98 916 367 1239

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026