Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT07121634
Brief Summary:
This randomized controlled trial compared misoprostol and isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. Low-risk women at 41+6 weeks gestation with an unfavorable cervix were randomized to receive either misoprostol or IMN. The primary outcome was the achievement of cervical ripeness (Bishop Score ≥6) within 40 hours.
Detailed Description:
This randomized controlled trial evaluates the effectiveness and safety of misoprostol versus isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies (≥41+0 weeks gestation). Favorable cervical status, reflected by a Bishop Score ≥6, is critical for successful vaginal delivery. Participants are low-risk pregnant women at 41+6 weeks with an unfavorable cervix. They are randomized to receive either 25 mcg of vaginal misoprostol or 40 mg of vaginal IMN, administered every 4 hours for up to 3 doses. Cervical status is assessed at regular intervals to determine the achievement of cervical ripening within 40 hours.
The primary outcome is the proportion of participants achieving a Bishop Score ≥6. Secondary outcomes include maternal parameters (labor progression, cesarean section rate, postpartum hemorrhage) and neonatal outcomes (Apgar scores, fetal heart rate tracing, and Doppler indices). The study aims to determine which agent more effectively facilitates cervical ripening and supports favorable delivery outcomes in late-term pregnancies.
Study:
NCT07121634
Study Brief:
Protocol Section:
NCT07121634