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IRCT20250414065324N1 IRCT 2025-07-12 Bandare-abbas University of Medical Sciences Management of the Missed Abortion Comparison of the Efficacy of Letrozole Pretreatment Followed by Misoprostol Versus Only Misoprostol for the Management of Missed Abortion 2025-07-23 anticipated 78 Complete https://irct.ir/trial/84555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study employed block randomization with a fixed block size. The unit of randomization was individual, and each participant was independently assigned to either the intervention or control group in a 1:1 ratio. The random sequence was generated using the Randomization Main Table software. No stratified randomization layers were applied. For allocation concealment, identically appearing, numbered drug packages were prepared by a pharmacist and distributed in a double-blind manner, ensuring that neither the participants nor the investigators were aware of group assignments, Blinding description: A double-blind design was strictly implemented in this study. Participants, attending physicians, and research team members responsible for data collection and outcome assessment were all blinded to the type of intervention (letrozole vs. placebo). Drug packages were coded based on the randomization sequence and were identical in appearance, taste, and size. Allocation of the intervention was performed according to a pre-generated randomization table. Data analysts will conduct statistical analyses without knowledge of group assignments. No Data Safety and Monitoring Committee (DSMC) was established for this study. 3 Missed Abortion. Intervention 1: Intervention group: Participants in this group receive oral letrozole at a dose of 10 milligrams per day for three consecutive days. Following the completion of letrozole administration, on the fourth day, vaginal misoprostol is administered at an initial dose of 800 micrograms, with up to two additional doses every 12 hours if necessary.Letrozole tablets (brand name: Letrozol, manufactured in Iran) are provided at a dosage of 10 milligrams. Letrozole is administered orally, and misoprostol is administered vaginally.Throughout the intervention process, vital signs and adverse effects are monitored and recorded regularly. If complete uterine evacuation is not achieved within 48 hours after the last dose of misoprostol, the patient will be referred for surgical curettage. Intervention 2: Control group: Participants in this group receive one placebo tablet per day for three consecutive days, identical in appearance to the letrozole tablets. Following the completion of placebo administration, vaginal misoprostol is administered on the fourth day at a dose of 800 micrograms, with up to two additional doses every 12 hours if needed. The placebo is taken orally, and misoprostol is administered vaginally. Vital signs and adverse events are monitored and documented regularly throughout the treatment period. If complete uterine evacuation is not achieved within 48 hours after the last misoprostol dose, the patient will be referred for surgical curettage. Yes - There is a plan to make this available What will be shared: De-identified participant-level data related to primary outcomes; Individual participant data will be stored in a coded and de-identified format. Only data related to primary outcomes—such as uterine evacuation status, need for curettage, and immediate adverse events—will be available for sharing upon request, after removal of any identifying information. When: Access to the data will begin six months after the publication of the final study results and will remain available for at least three years. To whom: Data will be available only to researchers affiliated with recognized academic or research institutions, upon submission of a formal request. Conditions: Data may be used solely for research purposes and statistical analyses related to reproductive health and maternal care. Secondary publication, commercial use, or usage without proper citation of the original source is not permitted. Applicants must submit a research proposal, intended use description, and a confidentiality agreement. Final access will be granted upon review and approval by the study team. Where to obtain: Applicants seeking access to study data or documentation should submit a formal request via the following email address: Email: a.ma8080@hums.ac.ir Further coordination will be carried out through this channel. How to obtain: The applicant must submit a formal request along with a research proposal and purpose description to the provided email address. The request will be reviewed within a maximum of 30 working days. If approved, de-identified data will be shared after signing a confidentiality agreement. Comments:
public Arvin Mahmoodi
International Affairs and Scientific Collaborations, Vice-Chancellery for Education of HUMS,Jomhuri Eslami Blvd, Bandar Abbas, IRAN
Bandar Abbas Iran (Islamic Republic of) 7914964157 +98 44 3672 0698 a.ma8080@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Arvin Mahmoodi
International Affairs and Scientific Collaborations, Vice-Chancellery for Education of HUMS,Jomhuri Eslami Blvd, Bandar Abbas, IRAN
Bandar Abbas Iran (Islamic Republic of) 7914964157 +98 44 3672 0698 a.ma8080@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Women Admitted to the Hospital with a Diagnosis of Missed Abortion Gestational Age ≥ 20 Weeks and ≤ 50 Days (Based on the First Sonography) Age ≥ 18 Years Old General Health Status Sufficient for Study Participation Hemoglobin Level ≥ 10 g/dL Diastolic Blood Pressure < 95 mmHg 18 years no limit Female History of Adrenal Disease, Cancer, Porphyria, Severe or Recurrent Liver Disease, Asthma, Thromboembolic Diseases Patients With Blood Pressure ≥ 130/80 mmHg History of Giving Birth to a Baby With Congenital Anomalies Breastfeeding Regular and Active Use of Prescribed, Hormonal, and Interfering Medications Prior to Study Entry Use of Intrauterine Device (IUD) Any Abnormalities in Baseline Tests Including: CBC, PT, PTT, INR, Urea, Creatinine, Na, K, Ca, Cl, Albumin, Fibrinogen, AST, ALT, ALP, Bili T, Bili D Symptoms of Allergy to any of the Prescribed Medications Unwillingness to Continue Participating in the Study or Withdrawing from Treatment at any Stage Failure to Attend Scheduled Follow-ups or Loss of Contact With the Research Team Heavy or Uncontrolled Vaginal Bleeding at any Point During the Intervention O02.1 Missed abortion Treatment - Drugs Placebo Intervention group: Participants in this group receive oral letrozole at a dose of 10 milligrams per day for three consecutive days. Following the completion of letrozole administration, on the fourth day, vaginal misoprostol is administered at an initial dose of 800 micrograms, with up to two additional doses every 12 hours if necessary.Letrozole tablets (brand name: Letrozol, manufactured in Iran) are provided at a dosage of 10 milligrams. Letrozole is administered orally, and misoprostol is administered vaginally.Throughout the intervention process, vital signs and adverse effects are monitored and recorded regularly. If complete uterine evacuation is not achieved within 48 hours after the last dose of misoprostol, the patient will be referred for surgical curettage. Control group: Participants in this group receive one placebo tablet per day for three consecutive days, identical in appearance to the letrozole tablets. Following the completion of placebo administration, vaginal misoprostol is administered on the fourth day at a dose of 800 micrograms, with up to two additional doses every 12 hours if needed. The placebo is taken orally, and misoprostol is administered vaginally. Vital signs and adverse events are monitored and documented regularly throughout the treatment period. If complete uterine evacuation is not achieved within 48 hours after the last misoprostol dose, the patient will be referred for surgical curettage. Rate of complete uterine evacuation, assessed via post-treatment transvaginal ultrasound. Timepoint: At baseline (Day 0): Prior to the intervention, transvaginal ultrasound is used to confirm the diagnosis of missed abortion. 48 hours after the last dose of misoprostol: Transvaginal ultrasound is used to assess for complete uterine evacuation. Method of measurement: Transvaginal ultrasound performed by an obstetrics and gynecology specialist using a transvaginal ultrasound probe to assess retained products of conception within the uterine cavity. Bandare-abbas University of Medical Sciences Approved 2024-05-20 Ethics committee of Hormozgan University of Medical Sciences Chamran Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)