An observational study in Whooping Cough, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by GlaxoSmithKline · Observational
Among 43 studies in Whooping Cough by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Whooping Cough · GlaxoSmithKline.
Among the 43 studies in Whooping Cough by GlaxoSmithKline, this one has the largest enrollment of the 11 observational ones that give a count, is one of 3 that started in 2018, is one of 11 observational ones, and was the 41st registered.
290 studies on the registry are indexed under Whooping Cough; 23 are open to participants now.
Browse Whooping Cough studies →None of the 43 studies in Whooping Cough by GlaxoSmithKline is open now. The open studies under Whooping Cough, anywhere →
Of the 13 Whooping Cough studies recruiting now, 2 (15%) set no upper age limit and 10 (77%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: female · healthy volunteers too.
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43 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 3 started in 2018.
This study's enrollment of 65,783 is above the median of 510 across 60 observational studies indexed under Whooping Cough.
Median enrollment 380 across the 32 interventional studies, 682 across the 11 observational. Of the 43 that completed or were terminated, 23 (53%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 43 studies in Whooping Cough by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study was to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that provided safety information to the public and healthcare providers. This was one of the largest cohorts of pregnant women vaccinated with Boostrix in the U.S. Through partnership between Kaiser Permanente Southern California (KPSC) and the sponsor, GlaxoSmithKline (GSK), information about the safety of maternal vaccination with Boostrix and maternal and infant adverse events (AEs) in a community setting was gained.
Pregnant women with prenatal care and continuous membership (allowing up to a 31-day gap) at KPSC between the 1st day of the 27th week of pregnancy and the index date
Inclusion Criteria:
For the analysis of congenital anomalies among live births, at birth and through six months of age, the following additional inclusion criteria for infants will be applied:
Note: Pregnant women vaccinated with Boostrix during pregnancy before the 27th week of gestation, with membership at the date of vaccination, and who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy in scope of this study will be part of a descriptive analysis (secondary objective).
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy.
Other: Safety assessment following routine immunization with Boostrix
This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy.
Other: Safety assessment following routine immunization with Boostrix
This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy.
Other: Safety assessment following routine immunization with Boostrix
This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group.
Other: Safety assessment following routine immunization with Boostrix
This group consisted of infants whose mothers belong to the Unexposed historical cohort women group.
Other: Safety assessment following routine immunization with Boostrix
This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group.
Other: Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Incidence Rate (Per 1000 Person-years) of Pre-specified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort-women Groups
The incidence rate (per 1000) of maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse events assessed were pre-eclampsia and eclampsia; Intra-uterine infections.
Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
Incidence Rate (Per 1000 Persons) of Prespecified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
Incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse event assessed was preterm delivery.
Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
Incidence Rate (Per 1000 Persons) of Pre-specified Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
The incidence rate (per 1000) of adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The pre-specified infant adverse event assessed was small for gestational age.
Time frame: From birth through 6 months of age
Incidence Rate (Per 1000 Person-years) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
The incidence rate (per 1000) of other maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.
Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
Incidence Rate (Per 1000 Persons) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups
The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; transfusion during delivery hospitalization.
Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups
The incidence rate (per 1000) of other infant adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other infant adverse events assessed were neonatal death, congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.
Time frame: From birth through 6 months of age
Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were pre-eclampsia and eclampsia; intra-uterine infections; poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.
Time frame: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks
Incidence Rate (Per 1000 Persons) of Women Adverse Events Presented for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. The adverse events of this analysis include the adverse events presented in the above outcomes as well as spontaneous and therapeutic abortion with or without congenital anomalies in pregnant women vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; spontaneous abortion; spontaneous abortion with congenital anomalies; therapeutic abortion; therapeutic abortion with congenital anomalies; transfusion during delivery hospitalization; preterm delivery.
Time frame: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks
Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The adverse events of this analysis include adverse events presented in the above outcomes, among the infants whose mothers were vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these infant adverse events was descriptive. The infant adverse events assessed were: small for gestational age; neonatal death; congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.
Time frame: From birth through 6 months of age
Data was collected for both pregnant women and their infants from Kaiser Permanente Southern California (KPSC) Electronic Health Records (EHR).
| Milestone | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants | Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy |
|---|---|---|---|---|---|---|
| Started | 16606 | 16606 | 65 | 16350 | 16088 | 68 |
| Completed | 16366 | 16166 | 65 | 16335 | 16071 | 68 |
| Not completed | 240 | 440 | 0 | 15 | 17 | 0 |
| Withdrew: Lost to follow-up | 238 | 435 | 0 | 0 | 0 | 0 |
| Withdrew: With unknown pregnancy outcome | 0 | 5 | 0 | 0 | 0 | 0 |
| Withdrew: Maternal death | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Neonatal death | 0 | 0 | 0 | 15 | 17 | 0 |
The incidence rate (per 1000) of maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse events assessed were pre-eclampsia and eclampsia; Intra-uterine infections.
| Events per 1000 persons-year | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women |
|---|---|---|
| Pre-eclampsia and eclampsia | 316.16 (296.24 to 337.42) | 219.00 (202.13 to 237.28) |
| Intra-uterine infections | 292.53 (273.56 to 312.81) | 207.35 (191.12 to 224.95) |
Incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse event assessed was preterm delivery.
| Events per 1000 persons | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women |
|---|---|---|
| Incidence Rate (Per 1000 Persons) of Prespecified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups | 64.63 (60.90 to 68.58) | 92.28 (87.84 to 96.94) |
The incidence rate (per 1000) of adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The pre-specified infant adverse event assessed was small for gestational age.
| Events per 1000 persons | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants |
|---|---|---|
| Incidence Rate (Per 1000 Persons) of Pre-specified Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups | 80.42 (76.30 to 84.76) | 75.00 (70.98 to 79.25) |
The incidence rate (per 1000) of other maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.
| Events per 1000 persons-year | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women |
|---|---|---|
| Poor fetal growth | 116.00 (103.99 to 129.40) | 137.63 (124.29 to 152.40) |
| Placental abruption | 56.63 (48.45 to 66.19) | 44.59 (37.30 to 53.32) |
| Preterm pre-labor rupture of membranes | 115.53 (103.52 to 128.94) | 141.52 (127.95 to 156.53) |
| Maternal death | 0.43 (0.11 to 1.72) | — |
The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; transfusion during delivery hospitalization.
| Events per 1000 persons | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women |
|---|---|---|
| Stillbirth/fetal death | 1.41 (0.93 to 2.11) | 2.41 (1.76 to 3.30) |
| Transfusion during delivery hospitalization | 12.79 (11.17 to 14.65) | 12.02 (10.43 to 13.84) |
The incidence rate (per 1000) of other infant adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other infant adverse events assessed were neonatal death, congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.
| Events per 1000 persons | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants |
|---|---|---|
| Neonatal death | 0.92 (0.55 to 1.52) | 1.06 (0.66 to 1.70) |
| Congenital anomalies of nervous system | 2.81 (2.11 to 3.76) | 2.36 (1.72 to 3.25) |
| Congenital anomalies of eye | 69.85 (66.05 to 73.87) | 60.48 (56.91 to 64.28) |
| Congenital anomalies of ear, face, or neck | 16.27 (14.43 to 18.35) | 8.14 (6.86 to 9.66) |
| Congenital anomalies of cardiovascular system | 24.40 (22.15 to 26.89) | 21.82 (19.67 to 24.20) |
| Congenital anomalies of respiratory system | 13.76 (12.08 to 15.68) | 10.32 (8.86 to 12.01) |
| Clefts | 1.96 (1.38 to 2.77) | 1.49 (1.00 to 2.23) |
| Congenital anomalies of upper gastrointestinal system | 67.83 (64.08 to 71.79) | 37.85 (35.02 to 40.92) |
| Congenital anomalies of lower gastrointestinal system | 1.35 (0.89 to 2.04) | 2.30 (1.67 to 3.17) |
| Congenital anomalies of genital organs | 21.71 (19.57 to 24.09) | 18.46 (16.48 to 20.68) |
| Congenital anomalies of renal system | 7.83 (6.58 to 9.31) | 5.91 (4.83 to 7.22) |
| Congenital anomalies of musculoskeletal system | 16.27 (14.43 to 18.35) | 10.63 (9.15 to 12.35) |
| Congenital anomalies of limb | 7.09 (5.91 to 8.51) | 6.90 (5.73 to 8.31) |
| Congenital anomalies of integument | 58.04 (54.57 to 61.74) | 29.65 (27.14 to 32.39) |
| Other and unspecified congenital anomalies | 1.96 (1.38 to 2.77) | 2.05 (1.46 to 2.89) |
The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were pre-eclampsia and eclampsia; intra-uterine infections; poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.
| Events per 1000 persons-year | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy |
|---|---|
| Pre-eclampsia and eclampsia | 354.50 (146.26 to 755.09) |
| Intra-uterine infections | 176.42 (45.85 to 525.92) |
| Poor fetal growth | 119.75 (20.81 to 453.17) |
| Preterm pre-labor rupture of membranes | 117.65 (20.45 to 445.22) |
The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. The adverse events of this analysis include the adverse events presented in the above outcomes as well as spontaneous and therapeutic abortion with or without congenital anomalies in pregnant women vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; spontaneous abortion; spontaneous abortion with congenital anomalies; therapeutic abortion; therapeutic abortion with congenital anomalies; transfusion during delivery hospitalization; preterm delivery.
| Events per 1000 persons | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy |
|---|---|
| Spontaneous abortion | 15.38 (0.80 to 94.03) |
| Transfusion during delivery hospitalization | 15.63 (0.82 to 95.41) |
| Preterm delivery | 46.88 (12.18 to 139.59) |
The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The adverse events of this analysis include adverse events presented in the above outcomes, among the infants whose mothers were vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these infant adverse events was descriptive. The infant adverse events assessed were: small for gestational age; neonatal death; congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.
| Events per 1000 persons | Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy |
|---|---|
| Small for gestational age | 116.67 (52.10 to 231.77) |
| Congenital anomalies of eye | 88.24 (36.38 to 188.56) |
| Congenital anomalies of ear, face, or neck | 73.53 (27.39 to 170.21) |
| Congenital anomalies of cardiovascular system | 14.71 (0.77 to 90.12) |
| Congenital anomalies of upper gastrointestinal system | 14.71 (0.77 to 90.12) |
| Congenital anomalies of genital organs | 44.12 (11.46 to 131.90) |
| Congenital anomalies of renal system | 14.71 (0.77 to 90.12) |
| Congenital anomalies of musculoskeletal system | 14.71 (0.77 to 90.12) |
| Congenital anomalies of integument | 102.94 (45.87 to 206.51) |
Collected over For each woman from date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy Group and Exposed cohort women-before 1st day of 27th week of pregnancy Group), and from an index date (Unexposed historical cohort women) until end of enrollment (up to 13 weeks) or pregnancy (up to 40 weeks). For infants, from birth through 6 months of age.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | 2/16,606 (0%) | 3,733/16,606 (22.5%) | — |
| Unexposed Historical Cohort Women | 0/16,606 (0%) | 3,679/16,606 (22.2%) | — |
| Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy | 0/65 (0%) | 18/65 (27.7%) | — |
| Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | 15/16,350 (0.1%) | 5,540/16,350 (33.9%) | — |
| Unexposed Historical Cohort Infants | 17/16,088 (0.1%) | 4,211/16,088 (26.2%) | — |
| Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy | 0/68 (0%) | 30/68 (44.1%) | — |
| Event | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants | Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy |
|---|---|---|---|---|---|---|
| Small for gestational ageGeneral disorders | — | — | — | 1278/15892 | 1172/15626 | 7/60 |
| Congenital anomalies of integumentGeneral disorders | — | — | — | 949/16350 | 477/16088 | 7/68 |
| Preeclampsia/eclampsiaGeneral disorders | 874/16606 | 588/16606 | 6/65 | — | — | — |
| Preterm deliveryGeneral disorders | 1019/15767 | 1435/15551 | 3/64 | — | — | — |
| Congenital anomalies of eyeGeneral disorders | — | — | — | 1142/16350 | 973/16088 | 6/68 |
| Congenital anomalies of ear, face or neckGeneral disorders | — | — | — | 266/16350 | 131/16088 | 5/68 |
| Congenital anomalies of upper gastrointestinal systemGeneral disorders | — | — | — | 1109/16350 | 609/16088 | 1/68 |
| Intra-uterine infectionsGeneral disorders | 811/16606 | 558/16606 | 3/65 | — | — | — |
| Congenital anomalies of genital organsGeneral disorders | — | — | — | 355/16350 | 297/16088 | 3/68 |
| Poor fetal growthGeneral disorders | 320/16606 | 368/16606 | 2/65 | — | — | — |
| Age, Customized(Participants) | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants | Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy | Total |
|---|---|---|---|---|---|---|---|
| 0-1 year | 0 | 0 | 0 | 16350 | 16088 | 68 | 32506 |
| 13 -51 year | 16606 | 16606 | 65 | 0 | 0 | 0 | 33277 |
| Sex: Female, Male(Participants) | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants | Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy | Total |
|---|---|---|---|---|---|---|---|
| Female | 16606 | 16606 | 65 | 7950 | 7725 | 36 | 48988 |
| Male | 0 | 0 | 0 | 8400 | 8363 | 32 | 16795 |
| Race/Ethnicity, Customized(Participants) | Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Women | Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy | Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy | Unexposed Historical Cohort Infants | Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy | Total |
|---|---|---|---|---|---|---|---|
| White | 2974 | 2974 | 14 | 0 | 0 | 0 | 5962 |
| Black | 1274 | 1274 | 5 | 0 | 0 | 0 | 2553 |
| Hispanic | 9689 | 9689 | 31 | 0 | 0 | 0 | 19409 |
| Asian | 2144 | 2144 | 10 | 0 | 0 | 0 | 4298 |
| Other-Unspecified | 525 | 525 | 5 | 16350 | 16088 | 68 | 33561 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Aug 2020, 27 months.
Results were first posted in May 2022, 1 year 9 months after primary completion.
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