Trial Outcomes & Findings for Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor (NCT NCT04392375)
NCT ID: NCT04392375
Last Updated: 2023-07-24
Results Overview
Measured acute antihypertension therapy between enrollment and delivery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Between enrollment and delivery, assessed up to 18 weeks
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
53
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Baseline characteristics by cohort
| Measure |
Nifedipine 30MG
n=53 Participants
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.
|
Placebo
n=49 Participants
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.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
31 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
32 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
49 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Pregnancy BMI
|
32.9 kg/m 2
n=5 Participants
|
32.0 kg/m 2
n=7 Participants
|
32.45 kg/m 2
n=5 Participants
|
|
BMI at delivery
|
37.8 kg/m 2
n=5 Participants
|
37 kg/m 2
n=7 Participants
|
37.4 kg/m 2
n=5 Participants
|
|
Nulliparous
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Chronic Hypertension
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Chronic hypertension on maintenance medication (beta-blocker)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Smoking during current pregnancy
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diabates
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Gestational age at delivery (week)
< 34 0/7
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gestational age at delivery (week)
34 0/7 - 36 6/7
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Gestational age at delivery (week)
> 37 0/7
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Neuraxial anesthesia
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Twin gestation
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fetal Growth Restriction
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between enrollment and delivery, assessed up to 18 weeksMeasured acute antihypertension therapy between enrollment and delivery
Outcome measures
| Measure |
Nifedipine 30MG
n=53 Participants
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.
|
Placebo
n=49 Participants
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.
|
|---|---|---|
|
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
|
18 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: At deliveryOutcome measures
| Measure |
Nifedipine 30MG
n=53 Participants
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.
|
Placebo
n=49 Participants
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.
|
|---|---|---|
|
Number of Participants Stratified by Route of Delivery
Cesarean Delivery
|
11 Participants
|
17 Participants
|
|
Number of Participants Stratified by Route of Delivery
Vaginal Delivery
|
42 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and delivery, assessed up to 18 weeksSome participants could have more than one indication for Cesarean Delivery.
Outcome measures
| Measure |
Nifedipine 30MG
n=11 Participants
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.
|
Placebo
n=17 Participants
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.
|
|---|---|---|
|
Number of Participants With Various Indications for Cesarean Delivery
Second stage arrest
|
1 Participants
|
5 Participants
|
|
Number of Participants With Various Indications for Cesarean Delivery
First stage arrest
|
8 Participants
|
6 Participants
|
|
Number of Participants With Various Indications for Cesarean Delivery
Nonreassuring fetal status
|
3 Participants
|
7 Participants
|
|
Number of Participants With Various Indications for Cesarean Delivery
Worsening maternal status
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and delivery, assessed up to 18 weeksOutcome measures
| Measure |
Nifedipine 30MG
n=18 Participants
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.
|
Placebo
n=27 Participants
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.
|
|---|---|---|
|
Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At deliveryOutcome measures
| Measure |
Nifedipine 30MG
n=53 Participants
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.
|
Placebo
n=49 Participants
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.
|
|---|---|---|
|
Number of Participants Who Required Acute Antihypertension Treatments Postpartum
|
20 Participants
|
19 Participants
|
Adverse Events
Nifedipine 30MG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place