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IRCT20240519061844N1 IRCT 2025-06-14 Bandare-abbas University of Medical Sciences Effect of Oral and Vaginal Misoprostol Evaluation and Comparison of the Effect of Vaginal and Oral Misoprostol for Cervical Ripening in Post-term Primigravida Mothers 2025-06-22 anticipated 80 Complete https://irct.ir/trial/76896 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method: Simple randomization. Participants are randomly assigned to one of the two intervention groups (oral or vaginal). This process is carried out using statistical software. Unit of Randomization: Individual. Each post-term primigravida mother is independently assigned to one of the intervention groups. Randomization Tool: Random Allocation Software. No Need for Allocation Concealment: Given the design and objectives of the study, allocation concealment is not necessary, and the allocation of participants to the groups is done transparently. 3 Post-term. Intervention 1: first Intervention group: Substance Name: Misoprostol Chemical Composition and Concentration: Misoprostol, Prostaglandin E1 analog Dosage: 50 micrograms Frequency of Administration: Every 3 to 6 hours, up to a maximum of 6 doses Duration of Administration: Until achieving a Bishop score of 7 or administration of up to 6 doses Route of Administration: Oral. Intervention 2: Second Intervention group: first Intervention group: Substance Name: Misoprostol Chemical Composition and Concentration: Misoprostol, Prostaglandin E1 analog Dosage: 25 micrograms Frequency of Administration: Every 3 to 6 hours, up to a maximum of 6 doses Duration of Administration: Until achieving a Bishop score of 7 or administration of up to 6 doses Route of Administration: Vaginal. Yes - There is a plan to make this available What will be shared: The shared materials will include de-identified individual participant data focusing on primary outcomes, along with essential study documents such as the full study protocol and data analysis plan. Only data pertinent to the primary outcomes will be shared. When: Data and associated documents will be made accessible beginning six months after publication of the study results and will remain available for a period of five years. To whom: Access will be granted primarily to academic and research institution-affiliated investigators. Requests from industry professionals will be considered on a case-by-case basis. Conditions: The shared data may only be used for scientific and academic research purposes. Applicants must agree to perform analyses strictly according to the approved study protocol, maintain participant confidentiality, and obtain additional ethical approval for any use beyond the original scope. Where to obtain: Applicants seeking access to the data should contact the Data Access Coordinator at the Research Center of Bandar Abbas Shariati Hospital. Additionally, for requested information, they may contact the project supervisor, Dr. Nastaran Taherpoor, via email at nst94@yahoo.com How to obtain: Applicants must submit a formal request outlining their research objectives and data analysis plan. Upon review and approval of these requests, the data and associated documents will be provided to the applicants. Comments:
public Nastaran Taherpour
Pedaran asemani
Bandar abbas Iran (Islamic Republic of) 7913973282 +98 76 3222 9507 Nst94@yahoo.com Bandare-abbas University of Medical Sciences scientific Nastaran Taherpour
Pedaran asemani
Bandar abbas Iran (Islamic Republic of) 7913973282 +98 76 3222 9507 Nst94@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Post-term primigravida mothers who have voluntarily agreed to participate in the study and have referred to Shariati Hospital in Bandar Abbas no limit no limit Female Presence of spontaneous uterine contractions Previous uterine surgery Oligohydramnios Placenta previa Intrauterine Growth Restriction (IUGR) Cesarean section Umbilical cord prolapse Unexplained vaginal bleeding Contraindications to the administration of prostaglandins Contraindications to labor induction Presence of renal or hepatic disease Uncontrolled epilepsy Allergy Intolerance O48.0 Post-term pregnancy Treatment - Drugs Treatment - Drugs first Intervention group: Substance Name: Misoprostol Chemical Composition and Concentration: Misoprostol, Prostaglandin E1 analog Dosage: 50 micrograms Frequency of Administration: Every 3 to 6 hours, up to a maximum of 6 doses Duration of Administration: Until achieving a Bishop score of 7 or administration of up to 6 doses Route of Administration: Oral Second Intervention group: first Intervention group: Substance Name: Misoprostol Chemical Composition and Concentration: Misoprostol, Prostaglandin E1 analog Dosage: 25 micrograms Frequency of Administration: Every 3 to 6 hours, up to a maximum of 6 doses Duration of Administration: Until achieving a Bishop score of 7 or administration of up to 6 doses Route of Administration: Vaginal Bishop Score. Timepoint: Baseline (before intervention): The Bishop score is measured at the baseline before the administration of the first dose of misoprostol.4 hours after each dose: The Bishop score is measured 4 hours after the administration of each dose of misoprostol to monitor initial changes in cervical ripening.8 hours after each dose: The Bishop score is measured 8 hours after the administration of each dose of misoprostol to track changes in cervical ripening.Finally, after achieving a Bishop score of 7 or after 6 doses: The Bishop score is measured either after achieving a score of 7 or after the administration of up to 6 doses of misoprostol, whichever occurs first. Method of measurement: Cervical dilation: Measured in centimeters using clinical examination by a specialist physician.Cervical effacement: Percentage of cervical thinning determined by clinical examination by a specialist physician.Cervical position: Position of the cervix (posterior, mid, anterior) assessed by clinical examination by a specialist physician.Cervical consistency: Softness, medium, or firmness of the cervix determined by clinical examination by a specialist physician.Fetal station: Position of the fetal head relative to the cervix assessed by clinical examination by a specialist physician. Bandare-abbas University of Medical Sciences Approved 2025-03-17 Ethics committee of Hormozgan University of Medical Sciences Chamran Blvd., Hormozgan University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)