Efficacy of Diltiazem for the Control of Blood Pressure in Puerperal Patients With Severe Preeclampsia

NCT04222855 | Completed DMC

• 1 other identifier: CCINSHAE-DGCHFR-HMD-DEI-2008
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Both preeclampsia and eclampsia are important health problems, being an important cause of maternal death in the world. Nifedipine has been used as the drug of choice for the treatment of hypertension during puerperium for more than 25 years. Diltiazem is an alternative calcium antagonist that is 1000 times less potent than nifedipine. There are no reports in the literature, no randomized clinical trials that prove the effectiveness of diltiazem for the control of blood pressure in post-partum patients with severe preeclampsia.

Conditions

Postpartum Preeclampsia

Outcome Measures

Primary Outcomes (3)

• Systolic blood pressure

  The register was taken during the 48-hour observation period

• Diastolic blood pressure

  The register was taken during the 48-hour observation period

• Mean blood pressure

  The register was taken during the 48-hour observation period

Secondary Outcomes (2)

• Number of hypotension episodes

  The counts was taken during the 48-hour observation period

• Days of stay in the intensive care unit

  The counts was taken during the two-weeks observation period

Study Arms (2)

Diltiazem

EXPERIMENTAL

Postpartum patients were administered (60 mg) orally every 8 hours with diltiazem (tables).

Drug: Diltiazem

Nifedipine

ACTIVE COMPARATOR

Postpartum patients were administered (10 mg) orally every 8 hours with nifedipine (capsule).

Drug: Diltiazem

Interventions

Diltiazem DRUG

Puerperal patients was administered (60 mg) orally every 8 hours with diltiazem (tables).

Diltiazem; Nifedipine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The following parameters of all patients were within the normal range: hematic biometry, urine and glucose tests, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, blood coagulation test including prothrombin time and activated partial thromboplastin time. Electrocardiogram and chest radiography showed no pathological data.

You may not qualify if:

• When the patient falls outside of the aforementioned parameters, or subjects with unstable medical conditions.

Sponsors & Collaborators

• Hospital de la Mujer: lead
• Ocharan-Hernández, Esther, MD, PhD: collaborator
• Vargas-De-León, Cruz, MSc: collaborator
• Calzada-Mendoza, Claudia, PhD: collaborator

Related Publications (1)

• Arias-Hernandez G, Vargas-De-Leon C, Calzada-Mendoza CC, Ocharan-Hernandez ME. Efficacy of Diltiazem for the Control of Blood Pressure in Puerperal Patients with Severe Preeclampsia: A Randomized, Single-Blind, Controlled Trial. Int J Hypertens. 2020 Jul 23;2020:5347918. doi: 10.1155/2020/5347918. eCollection 2020.

  PMID: 32774912 DERIVED

MeSH Terms

Interventions

Diltiazem

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician of the Intensive Care Unit

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: January 1, 2009
• Primary Completion: May 30, 2009
• Study Completion: May 30, 2009
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share