Trial Outcomes & Findings for Early Prevention of Preeclampsia Study (NCT NCT01547390)

NCT ID: NCT01547390

Last Updated: 2018-06-29

Results Overview

Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: within 3 months prior to delivery
• Results posted on: 2018-06-29

Participant Flow

Of 1470 women screened, 138 were screen positive, and 53 consented to participate in the study and were randomized. Ten women in the aspirin group and 13 in the placebo group dropped out of the study.

Participant milestones

Measure	Placebo Study subjects receiving placebo one tablet orally per day	Aspirin Study subjects receiving aspirin 81 mg one tablet orally per day.
Overall Study STARTED	27	26
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Measure	Placebo Study subjects receiving placebo one tablet orally per day	Aspirin Study subjects receiving aspirin 81 mg one tablet orally per day.
Overall Study Withdrawal by Subject	10	7
Overall Study termination of pregnancy	0	1
Overall Study Lost to Follow-up	0	2
Overall Study Adverse Event	3	0

Baseline Characteristics

Early Prevention of Preeclampsia Study

Baseline characteristics by cohort

Measure	Placebo n=14 Participants 1 capsule orally daily	Aspirin n=16 Participants 81mg, 1 capsule orally daily	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.6 years STANDARD_DEVIATION 6.1 • n=5 Participants	30.0 years STANDARD_DEVIATION 5.0 • n=7 Participants	30.8 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Sex · Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Sex · Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 3 months prior to delivery

Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).

Outcome measures

Measure	Placebo n=14 Participants 1 capsule orally, daily	Aspirin n=16 Participants 81mg, 1 capsule orally daily
Number of Participants With Preeclampsia	3 Participants	3 Participants

SECONDARY outcome

Timeframe: within 3 months of delivery

Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.

Statistical significance not reported due to the low recruitment and poor patient compliance.

Outcome measures

Measure	Placebo n=14 Participants 1 capsule orally, daily	Aspirin n=16 Participants 81mg, 1 capsule orally daily
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Small for gestational age (IUGR)	1 participants	1 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Gestational hypertension	0 participants	2 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Early preeclampsia	1 participants	1 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Severe preeclampsia	3 participants	3 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Preterm birth	2 participants	1 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Stillbirth	0 participants	0 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage Placental abruption	0 participants	0 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage antepartum hemorrhage	0 participants	0 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage neonatal death	0 participants	0 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage NICU admission	0 participants	2 participants
Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage miscarriage	1 participants	0 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=14 participants at risk 1 capsule orally, daily	Aspirin n=16 participants at risk 81mg, 1 capsule orally daily
Skin and subcutaneous tissue disorders Rash or hive	21.4% 3/14 • Number of events 3	0.00% 0/16

Additional Information

Dr. Anthony Odibo

University of South Florida

Phone: 813-259-0828

Email: aodibo@health.usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place