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IRCT20250811066824N1 IRCT 2025-09-04 Iran University of Medical Sciences Comparison of the Efficacy and Safety of Oral Misoprostol 100 µg versus 50 µg for Labor Induction in Term and Post-Term Pregnancies in Obese Women (BMI ≥ 30): A Randomized Controlled Trial MIS100/50-OBE Comparison of the effects and possible side effects of oral misoprostol 100 and 50 in patients with a body mass index above 30 for labor induction in term and post-term pregnancies 2025-09-23 anticipated 100 Recruiting https://irct.ir/trial/85859 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, after confirming eligibility and obtaining informed consent, participants will be randomized to one of two intervention groups: the intervention group receiving a dose of 100 micrograms of misoprostol and the group receiving a dose of 50 micrograms of misoprostol. Randomization mechanism: to ensure balanced distribution of characteristics (including age, parity, BMI, etc.) between the two groups and to reduce selection bias, block randomization will be used with a random number generator software (such as SPSS or Random.org). Generation of allocation sequence: The random allocation sequence will be generated prior to the study by a colleague who is not involved in recruitment or intervention (an independent randomization unit) with variable and concealed block sizes. Allocation concealment: to prevent selection bias, the generated allocation sequence will be stored in sealed, sequentially numbered envelopes or in a secure online system so that the treating physician and the patient are unaware of the next group assignment. Allocation: after final eligibility confirmation for enrollment, the treating physician will determine the group assignment for that patient by opening the sequential envelope or accessing the online system. 3 Labor Induction in Pregnant Women with Obesity (Body Mass Index BMI ≥ 30).. Intervention 1: Intervention group: Received misoprostol 50 micrograms vaginally.Method of administration: A 100-microgram misoprostol tablet is divided into two halves, and one half (50 micrograms) is administered.Dosage protocol: Administer every 4 to 6 hours based on the patient's clinical response (maximum of 4 doses in 24 hours).Monitoring: Continuous CTG monitoring and recording of adverse effects (uterine hyperstimulation, fever, nausea). Intervention 2: Control group: Administer misoprostol 100 mcg vaginally. Method of administration: Administer one 100 mcg tablet whole. Dosage protocol: Administer every 4 to 6 hours based on the patient's clinical response (maximum of 4 doses in 24 hours). Monitoring: Continuous CTG monitoring and record adverse events (uterine hyperstimulation, fever, nausea). Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD) will be shared via public research data repositories (such as Zenodo, Figshare, or Mendeley Data) under an Open Access license after the completion of the study and the publication of the primary results. The data will be provided in Excel or CSV format, accompanied by a README file containing variable descriptions and definitions. When: Immediately following publication of the primary manuscript: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (de-identified version) Clinical Study Report (based on CONSORT guidelines) Within a maximum of 12 months after study completion: De-identified Individual Participant Data (IPD) Analysis Scripts/Codes Data Dictionary To whom: Open Access (Public): Study Protocol Clinical Study Report (after publication) Statistical Analysis Plan (SAP) Informed Consent Form (de-identified version) Conditions: These documents will be made publicly available with full open access through public repositories (such as Open Access journals or data repositories). Conditions: Mandatory Citation: Any use of the data or documents requires proper citation of the primary published article from this study. Non-Commercial Use Only: The data may only be used for non-commercial, academic, and research purposes. Any commercial use is strictly prohibited without prior written permission from the principal investigators. Purpose Transparency: Requesters must transparently explain the specific purpose and intended use of the data in their application. Research Ethics Compliance: Users must commit to using the data in accordance with Helsinki Ethical Principles and all other relevant guidelines. Privacy Protection: Any attempt to re-identify participants or use the data outside the pre-defined framework is strictly forbidden. Where to obtain: Iranian Registry of Clinical Trials (www.irct.ir) The journal publishing the article (contingent on article acceptance) How to obtain: 1. Submission of Initial Request: The requester must send a formal written request in English or Persian to the principal investigator's email address (research@iums.ac.ir). This request must include the following: Specific purpose for using the data (e.g., conducting a meta-analysis, study validation, educational purposes). Description of the proposed research plan. Requester's organizational affiliation. Written commitment to adhere to ethical principles and cite the primary study. 2. Initial Review by the Access Committee: The request will be reviewed by the Data Access Committee (comprising the principal investigators and the ethics monitor). Review criteria: Alignment of the request's purpose with ethical principles. Requester's technical and scientific capability to use the data responsibly. No conflict with the interests of the participants or the principal investigators. This stage will take a maximum of 4 weeks. 3. Signing of the Data Transfer Agreement (DTA): If the request is approved, the requester must sign a Data Transfer Agreement (DTA). DTA content includes: Commitment to non-commercial use. Prohibition of any attempt to re-identify participants. Obligation to cite the primary article. Reporting the results of data analyses to the principal investigators. 4. Delivery of Data/Documents: Data will be provided in standard formats (e.g., CSV, SPSS, PDF) via secure platforms (such as encrypted email or FTP). Accompanying documentation includes: Data Dictionary (variable definitions). Statistical Analysis Plan. User guide (README file). 5. Post-Delivery Monitoring: The requester is obligated to provide an annual progress report on the use of the data. Any publication or report based on the data must be approved by the principal investigators prior to publication. Comments:
public Sheida Sheli
Central Headquarters Building, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 dr.sheyda.sheli@gmail.com Iran University of Medical Sciences scientific Sheida Sheli
Central Headquarters Building, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 dr.sheyda.sheli@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Pregnancy Status: Pregnant women at 37 to 41 weeks of gestation (term and post-term pregnancy). Body Mass Index (BMI): Have a BMI greater than 30. Indication for Induction: Have a medical indication for induction of labor with misoprostol.Health Status: Be in good general health (as determined by medical history and clinical judgment). No Contraindications: Have no known contraindications to the use of misoprostol (e.g., no history of previous cesarean delivery or major uterine surgery in this context*). 18 years 50 years Female Any medical or obstetric conditions that make the use of misoprostol dangerous (e.g., prior cesarean delivery, multiple gestation, placental problems, etc.). The patient’s unwillingness to participate in the study or to sign informed consent. Any known allergy or sensitivity to misoprostol. O61.0 Failure of induction of labor Treatment - Drugs Treatment - Drugs Intervention group: Received misoprostol 50 micrograms vaginally.Method of administration: A 100-microgram misoprostol tablet is divided into two halves, and one half (50 micrograms) is administered.Dosage protocol: Administer every 4 to 6 hours based on the patient's clinical response (maximum of 4 doses in 24 hours).Monitoring: Continuous CTG monitoring and recording of adverse effects (uterine hyperstimulation, fever, nausea). Control group: Administer misoprostol 100 mcg vaginally. Method of administration: Administer one 100 mcg tablet whole. Dosage protocol: Administer every 4 to 6 hours based on the patient's clinical response (maximum of 4 doses in 24 hours). Monitoring: Continuous CTG monitoring and record adverse events (uterine hyperstimulation, fever, nausea). The time interval, measured in hours, from the administration of the first dose of misoprostol to the complete birth of the baby. Timepoint: The exact time of the first dose administration and the time of birth will be meticulously recorded in the clinical reports. The difference between these two times will be calculated. Method of measurement: This variable is the most direct indicator for assessing the efficacy of the intervention (different doses of misoprostol). A shorter duration indicates a higher efficacy of the drug dose in accelerating the labor process. The proportion of deliveries concluded vaginally without requiring surgical intervention (cesarean section) to the total number of deliveries in each group, reported as a percentage. Timepoint: The mode of delivery (vaginal or cesarean) will be recorded for each patient in the research dataset. Method of measurement: This outcome measures the ultimate goal of labor induction. A higher rate in one group indicates the superiority of that intervention in achieving a lower-risk, physiological birth. Iran University of Medical Sciences Approved 2025-08-05 Ethics committee of Iran University of Medical Sciences Vice Chancellor for Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)