Comparison of the effect of misoprostol alone and misoprostol plus vaginal estrogen on cervical preparation for labour induction

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250225064853N4

Enrollment

Registered

2025-10-07

Start date

2025-09-25

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Cervical preparation for labor induction. Primary inadequate contractions

Interventions

Intervention 1: Intervention group: Group 1 (First Intervention)Participants in this group will receive only oral misoprostol. The dose is 25 micrograms every 2 hours, up to a maximum of 3 doses. This

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 45 years Singleton live pregnancy Gestational age between 36 and 41 weeks Candidate for labor induction Bishop score less than 6

Exclusion criteria

Exclusion criteria: Multiple pregnancies Abnormal Doppler flow of the placenta Fetal weight above 4 kg Non-reassuring non-stress test Fetal death Previous uterine surgery

Design outcomes

Primary

Measure	Time frame
Primary Outcome: Time to reach active labor phase. Timepoint: From intervention initiation to the onset of active labor. Method of measurement: Timing from the initiation of the intervention to the start of active labor.;Primary Outcome: Mode of delivery (vaginal or cesarean). Timepoint: After the completion of delivery. Method of measurement: Recorded type of delivery in the patient report.;Apgar scores at 1 and 5 minutes. Timepoint: After delivery. Method of measurement: Assessed by nurse or doctor at 1 and 5 minutes after delivery.	—

Measure

Time frame

Primary Outcome: Time to reach active labor phase. Timepoint: From intervention initiation to the onset of active labor. Method of measurement: Timing from the initiation of the intervention to the start of active labor.;Primary Outcome: Mode of delivery (vaginal or cesarean). Timepoint: After the completion of delivery. Method of measurement: Recorded type of delivery in the patient report.;Apgar scores at 1 and 5 minutes. Timepoint: After delivery. Method of measurement: Assessed by nurse or doctor at 1 and 5 minutes after delivery.

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Secondary

Measure	Time frame
Hospital length of stay. Timepoint: From admission to discharge. Method of measurement: Recorded duration of stay from admission to discharge.;Adverse events (such as bleeding or infection). Timepoint: During hospitalization and post-discharge follow-up. Method of measurement: Recorded and reported adverse events by doctors or nurses.;Patient satisfaction with treatment. Timepoint: After treatment completion. Method of measurement: Standard patient satisfaction questionnaire.	—

Measure

Time frame

Hospital length of stay. Timepoint: From admission to discharge. Method of measurement: Recorded duration of stay from admission to discharge.;Adverse events (such as bleeding or infection). Timepoint: During hospitalization and post-discharge follow-up. Method of measurement: Recorded and reported adverse events by doctors or nurses.;Patient satisfaction with treatment. Timepoint: After treatment completion. Method of measurement: Standard patient satisfaction questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarinaz Farahbod

Esfahan University of Medical Sciences

farinaz.farahbod@gmail.com+98 31 3792 3131

Outcome results

None listed

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