Trial Outcomes & Findings for Bupropion for Smoking Cessation During Pregnancy (NCT NCT01390246)

Last Updated: 2019-06-07

Results Overview

Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)

Results posted on

2019-06-07

Participant Flow

Pregnant smokers were recruited through the UTMB Ob/Gyn Department clinics and Regional Maternal Child Health Program (RMCHP) clinics. The study was also advertised through printed flyers, posters, and electronic media in clinic waiting areas. UTMB OB providers were notified of the study as well to refer potential participants.

Psychological screening using the PRIME MD survey was administered after enrollment at the first Study Visit. Using the score, subjects with evidence of major depression or any other severe, acute psychiatric symptom (eg, psychosis) were considered screen failures and referred back to their prenatal provider for treatment.

Participant milestones

Participant milestones
Measure	Bupropion SR Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Overall Study STARTED	30	35
Overall Study Visit 2: Quit Day	24	24
Overall Study Visit 6: End of Treatment	15	15
Overall Study Visit 7: 36-38 Weeks Gestation	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	20	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupropion for Smoking Cessation During Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupropion SR n=30 Participants Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=35 Participants Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Total n=65 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
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	30 Participants n=5 Participants	35 Participants n=7 Participants	65 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	24.5 years STANDARD_DEVIATION 5.56 • n=5 Participants	27.5 years STANDARD_DEVIATION 6.52 • n=7 Participants	26.2 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	35 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	35 Participants n=7 Participants	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)

Outcome measures

Outcome measures
Measure	Bupropion SR n=24 Participants Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=24 Participants Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment Craving for tobacco	1.50 MNWS Score Standard Deviation 1.11	2.07 MNWS Score Standard Deviation 1.23
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment Total score of withdrawal excluding craving	3.77 MNWS Score Standard Deviation 4.27	5.35 MNWS Score Standard Deviation 5.14

PRIMARY outcome

Timeframe: Quit date, visit 2 (one week after starting the 12-week course of therapy)

Outcome measures

Outcome measures
Measure	Bupropion SR n=24 Participants Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=24 Participants Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date Craving for tobacco	2.04 MNWS Score Standard Deviation 1.08	2.33 MNWS Score Standard Deviation 1.31
Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date Total score of withdrawal excluding craving	4.75 MNWS Score Standard Deviation 4.87	4.88 MNWS Score Standard Deviation 4.61

PRIMARY outcome

Timeframe: Visit 6 (end of 12 weeks of medication therapy)

The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air \< 4 ppm, and concentrations of cotinine in urine \< 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.

Outcome measures

Outcome measures
Measure	Bupropion SR n=30 Participants Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=35 Participants Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)	5 Participants	1 Participants

PRIMARY outcome

Timeframe: End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation

Outcome measures

Outcome measures
Measure	Bupropion SR n=30 Participants Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=35 Participants Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)	3 Participants	1 Participants

Adverse Events

Bupropion SR

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bupropion SR n=30 participants at risk Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=35 participants at risk Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Pregnancy, puerperium and perinatal conditions Infant stay in NICU >3 days due to premature delivery	0.00% 0/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	11.4% 4/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Pregnancy, puerperium and perinatal conditions Preeclampsia	3.3% 1/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	0.00% 0/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Pregnancy, puerperium and perinatal conditions Cord blood pH <7.01	3.3% 1/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	0.00% 0/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Pregnancy, puerperium and perinatal conditions Gestational Diabetes	0.00% 0/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	2.9% 1/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.

Other adverse events

Other adverse events
Measure	Bupropion SR n=30 participants at risk Subjects received 150 mg tablet bupropion SR orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.	Placebo n=35 participants at risk Subjects received matched bupropion SR placebo tablet orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks. Subjects also received behavioral interventions, which included 35-minute counseling sessions at each of the first 2 visits (enrollment and on the quit day) and 10 minutes of smoking cessation counseling at subsequent visits.
Nervous system disorders Headache	40.0% 12/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	17.1% 6/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Nervous system disorders Difficulty sleeping	33.3% 10/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	20.0% 7/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Respiratory, thoracic and mediastinal disorders Rhinorhea- Runny Nose	33.3% 10/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	22.9% 8/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Gastrointestinal disorders Dry mouth	43.3% 13/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	20.0% 7/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.
Psychiatric disorders Anxiety	46.7% 14/30 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.	17.1% 6/35 • For each pregnant woman, adverse events were assessed from enrollment through completion (or six months post partum). Neonatal adverse events were assessed at delivery and through infant discharge. We monitored for maternal AEs that could be related to bupropion, such as seizures, consistent BP \>140/90 mm Hg, headache, insomnia, rhinitis, dry mouth, and anxiety. We defined a priori which AEs would be considered fetal and neonatal SAEs: intrauterine fetal demise, preterm delivery \<34 weeks, clinically suspected fetal growth restriction, congenital malformations, cardiovascular anomalies, low birthweight (\<10%), Apgar scores \<7 at 5 minutes, and neonatal length of hospital stay \>3 days.

Additional Information

Dr. Tatiana Nanovskaya, PhD

University of Texas Medical Branch

Phone: 409-772-3908

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place