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

A study to evaluate and compare the effects and potential complications of different doses of misoprostol (100 micrograms and 50 micrograms) for labor induction in pregnant women with a body mass index (BMI) above 30 at term and post-term gestation.

Phase 3, single-blind (for patients), evaluator-blinded, randomized controlled trial with parallel groups, conducted on 92 patients (46 per group). Block randomization was performed using random number generation software.

This single-center clinical trial was conducted in the Obstetrics Department of Shahid Akbarabadi Educational Hospital on 92 patients with BMI > 30 to compare two vaginal misoprostol doses of 50 and 100 micrograms. Obstetric outcomes and complications were evaluated with 24-hour monitoring. The study employed a single-blind design for patients and assessors.

Gestational age 37-42 weeks BMI ≥ 30 Indication for induction of labor Favorable cervical status (Bishop Score ≥ 5) Singleton pregnancy Cephalic presentation Signed informed consent

Randomized clinical trial with a parallel design, comprising two intervention groups: Low-dose group (50 mcg vaginal misoprostol) Standard-dose group (100 mcg vaginal misoprostol) Objectives: To compare the efficacy and safety of two different doses of misoprostol for labor induction in pregnant women with BMI > 30. To evaluate outcomes including time to delivery, mode of delivery, and adverse effects. Characteristics: Vaginal administration with dose repetition based on a standardized protocol. Close clinical monitoring for 24 hours. Sample size: 92 patients (46 per group) using block randomization method.

Duration of labor; rate of successful vaginal delivery; incidence of uterine hyperstimulation; maternal side effects; infant status

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.

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.

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

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).

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.

Iranian Registry of Clinical Trials (www.irct.ir) The journal publishing the article (contingent on article acceptance)

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.