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IRCT20260522069482N1 IRCT 2026-10-29 Shahid Beheshti University of Medical Sciences Effectiveness of Enalapril Compared with Amlodipine in Controlling Blood Pressure During the Postpartum Period Comparison of the effectiveness of enalapril versus amlodipine in controlling blood pressure in the postpartum period: a clinical trial study 2026-10-23 anticipated 112 Recruiting https://irct.ir/trial/90299 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Block After screening eligible patients and obtaining written informed consent, participants will be randomly allocated to two groups: the enalapril group and the amlodipine group. Block randomization with blocks of four will be used to generate the random allocation sequence. Each block will contain two allocations to the enalapril group and two allocations to the amlodipine group, with the order of these allocations determined randomly using random number generation software. The resulting allocation sequence will be placed in opaque, sealed, sequentially numbered envelopes. After each eligible patient enters the study, the corresponding envelope will be opened by the person responsible for allocation, and the patient will be assigned to one of the two groups according to the allocation specified in the envelope. Thus, participants will be randomly allocated to the two groups while maintaining a balanced number of participants in each group throughout the allocation process. 3 Hypertension. Intervention 1: Intervention group: Patients in the intervention group will receive oral enalapril at an initial dose of 5 mg once daily. If the target blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) is not achieved after 24–48 hours, and the medication is well tolerated, the enalapril dose will be increased to 10 mg once daily. If necessary, the dose may be further titrated according to the study protocol to a maximum of 20 mg once daily (or 10 mg every 12 hours). Intervention 2: Control group:Patients in the control group will receive oral amlodipine at an initial dose of 5 mg once daily. If the target blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) is not achieved after 24–48 hours, and the medication is well tolerated, the amlodipine dose will be increased to 10 mg once daily. Yes - There is a plan to make this available What will be shared: Non-personally identifiable data and research-related documentation will be used solely for scientific, educational, and research purposes. When: Access period starts 6 months after results are published. To whom: Access to these data will only be possible for researchers, faculty members, graduate students, and other qualified individuals who submit a written request along with a description of the research purpose, data analysis method, and research ethics approval. Conditions: The data provided may only be used for scientific analyses consistent with the approved research objectives, including secondary statistical analyses, systematic reviews, meta-analyses, and other relevant research. The data may not be used for any attempt to identify individuals, transfer data to third parties without permission, commercial use, or any use contrary to research ethics. Where to obtain: Applicants seeking data or documentation for this study can first contact Dr. Kimia Motevalian, a physician at Mahdieh Hospital, Tehran, via email or the principal investigator's contact number. If necessary, correspondence can also be conducted through Mahdieh Hospital in Tehran. Requests will be addressed after review and in compliance with the principles of confidentiality, ethical considerations, and data-sharing regulations. How to obtain: The applicant must submit a formal request to the lead investigator or the relevant committee. The request should include the purpose of the data use, the proposed analysis method, the applicant’s institutional affiliation, and the plan for publishing the results. The requests will be reviewed by the research team or data monitoring committee for compliance with scientific objectives, ethical considerations, and confidentiality requirements. If approved, the anonymized data will be made available to the applicant via a secure method after signing a Data Use Agreement Comments:
public Kimia Motevalian
Mahdiyeh Hospital, Rajab Nia St., Shishgarkhaneh St., Fedaiyan-e Eslam St., Shush Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 mahdiyeh_hospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Kimia Motevalian
Mahdiyeh Hospital, Rajab Nia St., Shishgarkhaneh St., Fedaiyan-e Eslam St., Shush Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 mahdiyeh_hospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) requiring initiation or adjustment of pharmacological treatment. Informed consent for participation in the study 18 years 40 years Female History of hypersensitivity to the study medications (Enalapril or Amlodipine) 010 Pre-existing hypertension complicating pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group will receive oral enalapril at an initial dose of 5 mg once daily. If the target blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) is not achieved after 24–48 hours, and the medication is well tolerated, the enalapril dose will be increased to 10 mg once daily. If necessary, the dose may be further titrated according to the study protocol to a maximum of 20 mg once daily (or 10 mg every 12 hours). Control group:Patients in the control group will receive oral amlodipine at an initial dose of 5 mg once daily. If the target blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) is not achieved after 24–48 hours, and the medication is well tolerated, the amlodipine dose will be increased to 10 mg once daily. Mean reduction in systolic blood pressure. Timepoint: Measurements will be performed at predefined time points, including baseline (before the first dose of the medication) and subsequently at 2, 4, 8, 12, 24, 48, and 72 hours after treatment initiation. Method of measurement: A calibrated digital blood pressure monitor. Mean reduction in diastolic blood pressure. Timepoint: Measurements will be performed at predefined time points, including baseline (before the first dose of the medication) and at 2, 4, 8, 12, 24, 48, and 72 hours after treatment initiation. Method of measurement: A calibrated digital blood pressure monitor. Need for rescue labetalo. Timepoint: Blood pressure will be measured at predefined time points, including baseline (before the first dose of the medication) and subsequently at 2, 4, 8, 12, 24, 48, and 72 hours after treatment initiation. Method of measurement: A calibrated digital blood pressure monitor. Readmission to hospital. Timepoint: Patients will be followed up on days 3, 7, and 10 after discharge to document hospital readmission. Method of measurement: Patients will be followed up after discharge through review of electronic health records and telephone contact. Research Deputy of Shahid Beheshti University of Medical Sciences Approved 2026-02-01 The Ethics Committee of Shahid Beheshti University of Medical Sciences “Shoosh Square – Fadaeian Eslam Street, Shishehgar Khaneh Street, Rajabnia Street Tehran Tehran Iran (Islamic Republic of)