Gestational Hypertension, Hypertension, Pregnancy-Induced, Postpartum Preeclampsia, Postpartum Pregnancy-Induced Hypertension, Pre-Eclampsia, Superimposed Pre-Eclampsia
Conditions
Keywords
readmission, triage visit for pregnancy related hypertension, hydrochlorothiazide
Brief summary
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
Detailed description
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.
Interventions
DRUGHydrochlorothiazide 50mg Tablet
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.
DRUGPlacebo Tablet
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomization will be performed by a person not involved in the clinical trial using a computer random list of numbers generated using STATA (StataCorp 14.0, Dallas, TX). This list of random number assignments will be kept secure and sent directly to the investigational drug service (IDS), who will be responsible for the allocation and dispensing of the medications
Intervention model description
double-blind randomized placebo controlled clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Required Re-Admission or Triage Visit | 1-6 weeks postpartum | Any participants who had a visit to the hospital during the 1-6 weeks postpartum. |
| Number of Participants That Need Additional Antihypertensive Therapy | 1-6 weeks postpartum | Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 1-6 weeks postpartum | Days that participants required to be in-house in the postpartum period |
| Total Additional Doses of Anti-hypertensive Therapy | 1-6 weeks postpartum | Number of participants that receive one additional doses in the 1-6 weeks postpartum |
| Elevation of Blood Pressure >150/90 | 1-6 weeks postpartum | Number of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window |
| Severe Composite Maternal Morbidity | 1-6 weeks postpartum | Number of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death. |
| Adverse Events | 1-6 weeks Postpartum | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Bush, M.D.
UTMB
Participant flow
Pre-assignment details
A total of 453 individuals were initially recorded based on early recruitment and screening logs. After applying eligibility criteria and accounting for withdrawals prior to study start, 400 participants were enrolled and began the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 400 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 343 Participants |
| Region of Enrollment United States | 199 participants |
| Sex: Female, Male Female | 400 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 196 |
| other Total, other adverse events | 1 / 196 | 1 / 196 |
| serious Total, serious adverse events | 1 / 196 | 0 / 196 |
Outcome results
None listed