Preeclampsia Severe
Conditions
Keywords
preeclampsia severe, Nifedipine 30MG, placebo controlled
Brief summary
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
Detailed description
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features. After diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. Patients were approached about study and if consented then were then randomized to placebo or nifedipine 30XL daily until delivery occurred.
Interventions
DRUGNifedipine 30 MG
Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.
DRUGPlacebos
At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by The American College of Obstetricians and Gynecologists (ACOG) criteria. * Diagnosis of preeclampsia with severe features with decision made to induce labor. The patient may or may not have already received acute treatment for severe blood pressures.
Exclusion criteria
* Known allergy or adverse reaction to Nifedipine or any medical condition where Nifedipine is contraindicated, such as galactose intolerance, severe gastrointestinal (GI) structure, and GI hypomotility disorder. * Currently receiving Nifedipine XL as part of hypertension management prior to induction of labor * Participation in another trial that affects the primary outcome without prior approval * Physician/provider or patient refusal * Participation in this trial in a prior pregnancy * Triplet or higher order pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Between enrollment and delivery, assessed up to 18 weeks | Measured acute antihypertension therapy between enrollment and delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Stratified by Route of Delivery | At delivery | — |
| Number of Participants With Various Indications for Cesarean Delivery | Between enrollment and delivery, assessed up to 18 weeks | Some participants could have more than one indication for Cesarean Delivery. |
| Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | Between enrollment and delivery, assessed up to 18 weeks | — |
| Number of Participants Who Required Acute Antihypertension Treatments Postpartum | At delivery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nifedipine 30MG Oral administration of 30mg Nifedipine XL q24 hours until delivery
Nifedipine 30 MG: Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure. | 53 |
| Placebo Matching placebo group q24hrs until delivery
Placebos: At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. | 49 |
| Total | 102 |
Baseline characteristics
| Characteristic | Placebo | Nifedipine 30MG | Total |
|---|---|---|---|
| Age, Continuous | 31 years | 29 years | 30 years |
| BMI at delivery | 37 kg/m 2 | 37.8 kg/m 2 | 37.4 kg/m 2 |
| Chronic Hypertension | 14 Participants | 13 Participants | 27 Participants |
| Chronic hypertension on maintenance medication (beta-blocker) | 6 Participants | 7 Participants | 13 Participants |
| Diabates | 8 Participants | 12 Participants | 20 Participants |
| Fetal Growth Restriction | 1 Participants | 5 Participants | 6 Participants |
| Gestational age at delivery (week) < 34 0/7 | 3 Participants | 2 Participants | 5 Participants |
| Gestational age at delivery (week) 34 0/7 - 36 6/7 | 25 Participants | 28 Participants | 53 Participants |
| Gestational age at delivery (week) > 37 0/7 | 21 Participants | 23 Participants | 44 Participants |
| Neuraxial anesthesia | 47 Participants | 46 Participants | 93 Participants |
| Nulliparous | 36 Participants | 34 Participants | 70 Participants |
| Pregnancy BMI | 32.0 kg/m 2 | 32.9 kg/m 2 | 32.45 kg/m 2 |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 3 Participants | 15 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 41 Participants | 32 Participants | 73 Participants |
| Region of Enrollment United States | 49 participants | 53 participants | 102 participants |
| Sex: Female, Male Female | 49 Participants | 53 Participants | 102 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking during current pregnancy | 2 Participants | 2 Participants | 4 Participants |
| Twin gestation | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
Measured acute antihypertension therapy between enrollment and delivery
Time frame: Between enrollment and delivery, assessed up to 18 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine 30MG | Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | 18 Participants |
| Placebo | Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | 27 Participants |
Secondary
Number of Participants Stratified by Route of Delivery
Time frame: At delivery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifedipine 30MG | Number of Participants Stratified by Route of Delivery | Cesarean Delivery | 11 Participants |
| Nifedipine 30MG | Number of Participants Stratified by Route of Delivery | Vaginal Delivery | 42 Participants |
| Placebo | Number of Participants Stratified by Route of Delivery | Cesarean Delivery | 17 Participants |
| Placebo | Number of Participants Stratified by Route of Delivery | Vaginal Delivery | 32 Participants |
Secondary
Number of Participants Who Required Acute Antihypertension Treatments Postpartum
Time frame: At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine 30MG | Number of Participants Who Required Acute Antihypertension Treatments Postpartum | 20 Participants |
| Placebo | Number of Participants Who Required Acute Antihypertension Treatments Postpartum | 19 Participants |
Secondary
Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy
Time frame: Between enrollment and delivery, assessed up to 18 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifedipine 30MG | Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | 8 Participants |
| Placebo | Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy | 6 Participants |
Secondary
Number of Participants With Various Indications for Cesarean Delivery
Some participants could have more than one indication for Cesarean Delivery.
Time frame: Between enrollment and delivery, assessed up to 18 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifedipine 30MG | Number of Participants With Various Indications for Cesarean Delivery | First stage arrest | 8 Participants |
| Nifedipine 30MG | Number of Participants With Various Indications for Cesarean Delivery | Second stage arrest | 1 Participants |
| Nifedipine 30MG | Number of Participants With Various Indications for Cesarean Delivery | Nonreassuring fetal status | 3 Participants |
| Nifedipine 30MG | Number of Participants With Various Indications for Cesarean Delivery | Worsening maternal status | 2 Participants |
| Placebo | Number of Participants With Various Indications for Cesarean Delivery | Worsening maternal status | 1 Participants |
| Placebo | Number of Participants With Various Indications for Cesarean Delivery | First stage arrest | 6 Participants |
| Placebo | Number of Participants With Various Indications for Cesarean Delivery | Nonreassuring fetal status | 7 Participants |
| Placebo | Number of Participants With Various Indications for Cesarean Delivery | Second stage arrest | 5 Participants |