]>
IRCT20250513065720N1 IRCT 2025-10-20 Kerman University of Medical Sciences The Effect of Oral and Vaginal Misoprostol on the Duration of first Labor Induction The Effect of Oral Vs Vaginal Misoprostol on The Duration of Induction of First Labor 2025-08-22 anticipated 70 Complete https://irct.ir/trial/85164 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Present Study Will be a Randomized Clinical Trial Study. The Statistical Population of this Study will be Pregnant Mothers in Their First Trimester Who are Candidates for Labor Induction and Who Refer to Afzalipour, Kerman. The Random Allocation Sequence will be Generated by an Independent Statistician Using Computer-Generated Random Numbers (Blockrand Package in R Software) with Variable Block Sizes of 4 and 6, in a 1:1 Ratio (Oral Misoprostol : Vaginal Misoprostol). Allocation Concealment will be Ensured Using Prepared By The Statistician, Who Is Not Involved in Patient Enrolment or Treatment. Participant Enrolment will be Carried out by the Attending Physician or Midwife, who will open The next Envelope in Sequence at the Time of Enrolment to Determine Group Allocation. Due to the Nature of the Interventions, Blinding of Participants and Care Providers is not Feasible; However, Outcome Assessors and Data Analysts Will Remain Blinded to Group Allocation. 3 Childbirth. Intervention 1: Intervention Group 1: Misoprostol 50 Microgram Tablets (Mizotec Tablets, Abu Rayhan Pharmaceutical Company) Orally Every 6 Hours Until Reaching a Bishop Score of more than 8 or a Maximum Misoprostol Dose of 200 Micrograms or the Onset of Active Labor and Cervical Dilatation. Intervention 2: Intervention Group 2: Misoprostol 25 Microgram Tablet (Mizotec Tablets, Abu Raihan Pharmaceutical Company) Vaginally Every 6 Hours Until Reaching a Bishop Score of More than 8 or a Maximum Misoprostol Dose of 200 Micrograms or the Onset of the Active Phase of Labor and Cervical Dilatation. Yes - There is a plan to make this available What will be shared: All data is Potentially Shareable after De-Identifying Individuals. When: starting 6 Months after Publication To whom: People Working in Academic Institutions Conditions: With Previous Agreement with the Corresponding Author Where to obtain: Corresponding Author, Email Address How to obtain: Email Address Comments:
public Maryam Toghrali
Afzalipour Hospital, Emam Khomeini Blv.
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8000 www.dr.maryamtoghroli@gmail.com Kerman University of Medical Sciences scientific Maryam Toghrali
Afzalipour Hospital, Emam Khomeini Blv.
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8000 www.dr.maryamtoghroli@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Term Pregnancy (Less than or Equal to 37 weeks of Gestation) with a Singleton is Estimated based on the LMP Criterion (if Regularly and Reliably Confirmed by a Specialist Physician) or Ultrasound. Bishop Score Less than or Equal to 6 Cephalic Presentation of the fetus Having an Intact Membrane Reactivity of the Non-Stress Test Amniotic fluid volume less than 5 Estimated Fetal Weight less than 4000 Grams First Birth of a Pregnant Mother no limit no limit Female Pregnant women with contraindications to vaginal delivery Chorioamnionitis HIV positivity Previous uterine surgery Abnormal fetal heartbeat pattern Vaginal Bleeding and Women with Known Hypersensitivity to Misoprostol or Prostaglandin Analogues O75.8 Other specified complications of labor and delivery Treatment - Drugs Treatment - Drugs Intervention Group 1: Misoprostol 50 Microgram Tablets (Mizotec Tablets, Abu Rayhan Pharmaceutical Company) Orally Every 6 Hours Until Reaching a Bishop Score of more than 8 or a Maximum Misoprostol Dose of 200 Micrograms or the Onset of Active Labor and Cervical Dilatation. Intervention Group 2: Misoprostol 25 Microgram Tablet (Mizotec Tablets, Abu Raihan Pharmaceutical Company) Vaginally Every 6 Hours Until Reaching a Bishop Score of More than 8 or a Maximum Misoprostol Dose of 200 Micrograms or the Onset of the Active Phase of Labor and Cervical Dilatation. Time from Intervention to Natural Birth. Timepoint: From the time of the first dose of Misoprostol to the delivery of the Baby. Method of measurement: Clinical Record, Physical Examination. Kerman University of Medical Sciences Approved 2025-04-29 Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences Afzalipour Hospital, Emam Khomeini Blv. Kerman Kerman Iran (Islamic Republic of)