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16-0280

Postpartum management of hypertension in pregnancy with hydrochlorothiazide
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT03298802
readmission
triage visit for pregnancy related hypertension
hydrochlorothiazide
Source : Importé depuis le centre
Pre-Eclampsia
Gestational Hypertension
Superimposed Pre-Eclampsia
Hypertension, Pregnancy-Induced
Postpartum Pregnancy-Induced Hypertension
Postpartum Preeclampsia
Recrutement possiblement ouvert
Dernière modification : 2023/12/06
Type de recherche

Interventionnel

Médicament expérimental

Phase 3


Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Pre-Eclampsia

Gestational Hypertension

Superimposed Pre-Eclampsia

Hypertension, Pregnancy-Induced

Postpartum Pregnancy-Induced Hypertension

Postpartum Preeclampsia

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

Female

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

Maternal age ≥ 18 years and <50 years.

Diagnosis of gestational hypertension* or preeclampsia^ at any time during pregnancy, labor or postpartum.

defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both) or ^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.)

Exclusion Criteria:

Subject requiring antihypertensive therapy at time of screening.
Planned discharge with oral anti-hypertensive medication.
Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).
Subject not able to follow up postpartum.
Lactose intolerance.
Pre-gestational diabetes.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Hydrochlorothiazide 50mg Tablet Donnée non disponible Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
  • Inconnu
  • Placebo Tablet Donnée non disponible Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
  • Inconnu
  • Hydrochlorothiazide 50mg Tablet
    État du recrutement
    unknown
    Placebo Tablet
    État du recrutement
    unknown
    Données à jour depuis : 6 décembre 2023

    Description de l'étude

    Résumé de l'étude

    Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

    Source : Importé depuis le centre

    To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensive therapy and number of triage visits.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 6 décembre 2023
    Données à jour depuis : 22 mars
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT03298802