Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure

NCT01761916 | Completed Phase 4 DMC

• 1 other identifier: CLONCAP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy. Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification. The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive. Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril. There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose. The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.

Conditions

Preeclampsia

Keywords

captopril, clonidine, pregnancy-induced hypertension,

Outcome Measures

Primary Outcomes (1)

• Time until resolution of very high blood pressure episode

  The time until resolution of very high blood pressure episode after clonidin or captopril use.

  During hospital stay, up until one month postpartum

Secondary Outcomes (1)

• Maternal outcomes

  During hospital stay, up until one month postpartum

Study Arms (2)

CLONIDINE

EXPERIMENTAL

Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)

Drug: CLONIDINE

CAPTOPRIL

ACTIVE COMPARATOR

Postpartum patients with very high blood pressure will be treated with oral CAPTOPRIL (25mg)

Drug: CAPTOPRIL

Interventions

CLONIDINE DRUG

Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)

Also known as: CLON

CLONIDINE

CAPTOPRIL DRUG

Postpartum patients with very high blood pressure will be treated with oral captopril (25mg)

Also known as: CAP

CAPTOPRIL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hypertensive disorders of pregnancy;
• Postpartum;
• Age 18 to 45 years;
• Very high blood pressure

You may not qualify if:

• Cardiac disease;
• Smoking;
• Use of illicit drugs that may interfere with maternal hemodynamics;
• Contraindications to the use of captopril: renal failure, chronic liver disease and hypersensitivity to the drug;
• Contraindications to the use of clonidine: sinus node disease, chronic liver disease and hypersensitivity to the drug;
• Inability to receive postpartum oral medications

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

IMIP

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (2)

• Noronha Neto C C, Maia SS, Katz L, Coutinho IC, Souza AR, Amorim MM. Clonidine versus Captopril for Severe Postpartum Hypertension: A Randomized Controlled Trial. PLoS One. 2017 Jan 26;12(1):e0168124. doi: 10.1371/journal.pone.0168124. eCollection 2017.

  PMID: 28125624 DERIVED

• Noronha-Neto C, Katz L, Coutinho IC, Maia SB, Souza AS, Amorim MM. Clonidine versus captopril for treatment of postpartum very high blood pressure: study protocol for a randomized controlled trial (CLONCAP). Reprod Health. 2013 Jul 30;10:37. doi: 10.1186/1742-4755-10-37.

  PMID: 23899372 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Interventions

Clonidine; Captopril

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Carlos Noronha, MD

  IMIP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD pHD

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: January 7, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 29, 2013

Record last verified: 2013-06

Locations

BR (1)