aspirin and Abnormalities, Congenital studies

Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.
acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity.

Research Excerpts

Excerpt	Relevance	Reference
"The purpose of this study was to determine, on the basis of published reports, whether aspirin use during the first trimester of pregnancy is associated with an increased risk of congenital malformations."	8.81	Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. ( Boskovic, R; Costei, A; Koren, G; Kozer, E; Nikfar, S; Nulman, I, 2002)
"The purpose of this study was to determine, on the basis of published reports, whether aspirin use during the first trimester of pregnancy is associated with an increased risk of congenital malformations."	4.81	Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. ( Boskovic, R; Costei, A; Koren, G; Kozer, E; Nikfar, S; Nulman, I, 2002)
"Today, pregnancy is no longer considered impossible in women with lupus."	2.53	Pregnancy in women with systemic lupus erythematosus (SLE). ( Moroni, G; Ponticelli, C, 2016)

Research

Studies (17)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)

Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g

Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g

Fetal Outcome 4 - Incidence of Fetal Loss

Fetal Outcome 5 - Incidence of Spontaneous Abortion

Fetal Outcome 6 - Incidence of All Stillbirth

Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy

Timeframe	Studies, this research(%)	All Research%
pre-1990	6 (35.29)	18.7374
1990's	3 (17.65)	18.2507
2000's	3 (17.65)	29.6817
2010's	5 (29.41)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Bloor, M	1
Paech, M	1
Moroni, G	1
Ponticelli, C	1
Kristensen, DM	1
Mazaud-Guittot, S	1
Gaudriault, P	1
Lesné, L	1
Serrano, T	1
Main, KM	1
Jégou, B	1
Luk, YS	1
Man, EM	1
Sy, AN	1
Capone, C	1
Burjonrappa, S	1
Kozer, E	1
Nikfar, S	1
Costei, A	1
Boskovic, R	1
Nulman, I	1
Koren, G	1
HARLEY, JD	1
Bonaminio, PN	1
de Regnier, R	1
Chang, E	1
Day, N	1
Manzi, S	1
Ramsey-Goldman, R	1
Vroom, F	1
van den Berg, PB	1
de Jong-van den Berg, LT	1
Tunbridge, RD	1
Coulam, CB	1
Tiboni, GM	1
Iammarrone, E	1
Piccirillo, G	1
Liberati, M	1
Bellati, U	1
Shepard, TH	1
Wilson, JG	1
Gavan, JA	1
Nielsen, FH	1
Sunde, ML	1
Hoekstra, WG	1
Palmer, AK	1
Warkany, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
The Copenhagen Analgesic Study[NCT04369222]		600 participants (Anticipated)	Observational	2020-03-01	Recruiting
Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension: A Pilot Study[NCT04908982]	Phase 4	60 participants (Anticipated)	Interventional	2021-05-28	Recruiting
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)[NCT02409680]		11,976 participants (Actual)	Interventional	2016-03-23	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	Participants (Count of Participants)
Intervention Arm	189
Placebo Arm	230

Intervention	Participants (Count of Participants)
Intervention Arm	1078
Placebo Arm	1153

Intervention	Participants (Count of Participants)
Intervention Arm	78
Placebo Arm	101

Intervention	Participants (Count of Participants)
Intervention Arm	303
Placebo Arm	353

Intervention	Participants (Count of Participants)
Intervention Arm	134
Placebo Arm	152

Intervention	Participants (Count of Participants)
Intervention Arm	141
Placebo Arm	166

- Incidence of Medical Termination of Pregnancy (NCT02409680)
Timeframe: At delivery

Incidence of Hypertensive Disorders of Pregnancy

Intervention	Participants (Count of Participants)
Intervention Arm	42
Placebo Arm	30

- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy. (NCT02409680)
Timeframe: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)

Incidence of Perinatal Mortality

Intervention	Participants (Count of Participants)
Intervention Arm	352
Placebo Arm	325

- Incidence of Perinatal Mortality (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Incidence of Preterm Birth

Intervention	Participants (Count of Participants)
Intervention Arm	264
Placebo Arm	309

The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous. (NCT02409680)
Timeframe: At delivery

Incidence of Small for Gestational Age (SGA)

Intervention	Participants (Count of Participants)
Intervention Arm	668
Placebo Arm	754

- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 1 - Incidence of Vaginal Bleeding

Intervention	Participants (Count of Participants)
Intervention Arm	1506
Placebo Arm	1564

- Vaginal bleeding (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 2 - Incidence of Antepartum Hemorrhage

Intervention	Participants (Count of Participants)
Intervention Arm	214
Placebo Arm	246

- Antepartum hemorrhage (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 3 - Incidence of Postpartum Hemorrhage

Intervention	Participants (Count of Participants)
Intervention Arm	26
Placebo Arm	25

- Postpartum hemorrhage (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 4 - Incidence of Maternal Mortality

Intervention	Participants (Count of Participants)
Intervention Arm	54
Placebo Arm	43

- Incidence of Maternal Mortality (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 5 - Incidence of Late Abortion

Intervention	Participants (Count of Participants)
Intervention Arm	9
Placebo Arm	12

- Incidence of Late Abortion (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 6 - Change in Maternal Hemoglobin

Intervention	Participants (Count of Participants)
Intervention Arm	23
Placebo Arm	30

Hemoglobin < 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation (NCT02409680)
Timeframe: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA.

Maternal Outcome 7 - Incidence of Preterm, Preeclampsia

Intervention	Participants (Count of Participants)
Intervention Arm	290
Placebo Arm	333

Early preterm delivery (<34 weeks) and hypertensive disorders (i.e.: preeclampsia) (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Article	Year
Nonsteroidal anti-inflammatory drugs during pregnancy and the initiation of lactation. Anesthesia and analgesia, 2013, Volume: 116, Issue:5 Topics: Abortion, Habitual; Adult; Anti-Inflammatory Agents, Non-Steroidal; Antiphospholipid Syndrome; Aspir	2013
Pregnancy in women with systemic lupus erythematosus (SLE). European journal of internal medicine, 2016, Volume: 32 Topics: Abortion, Spontaneous; Antibodies, Antiphospholipid; Anticoagulants; Antiphospholipid Syndrome; Aspi	2016
Analgesic use - prevalence, biomonitoring and endocrine and reproductive effects. Nature reviews. Endocrinology, 2016, Volume: 12, Issue:7 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Commerce;	2016
Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. American journal of obstetrics and gynecology, 2002, Volume: 187, Issue:6 Topics: Abnormalities, Drug-Induced; Aspirin; Case-Control Studies; Cohort Studies; Congenital Abnormalities	2002
Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. American journal of obstetrics and gynecology, 2002, Volume: 187, Issue:6 Topics: Abnormalities, Drug-Induced; Aspirin; Case-Control Studies; Cohort Studies; Congenital Abnormalities	2002
Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. American journal of obstetrics and gynecology, 2002, Volume: 187, Issue:6 Topics: Abnormalities, Drug-Induced; Aspirin; Case-Control Studies; Cohort Studies; Congenital Abnormalities	2002
Aspirin consumption during the first trimester of pregnancy and congenital anomalies: a meta-analysis. American journal of obstetrics and gynecology, 2002, Volume: 187, Issue:6 Topics: Abnormalities, Drug-Induced; Aspirin; Case-Control Studies; Cohort Studies; Congenital Abnormalities	2002
The management of pregnancy in hypertensive patients. Postgraduate medical journal, 1994, Volume: 70, Issue:829 Topics: Adult; Antihypertensive Agents; Aspirin; Blood Pressure; Congenital Abnormalities; Female; Humans; H	1994

Article	Year
Bilateral hypoplasia of the internal carotid arteries. Singapore medical journal, 2010, Volume: 51, Issue:9 Topics: Angiography; Aspirin; Carotid Artery, Internal; Congenital Abnormalities; Humans; Imaging, Three-Dim	2010
Congenital spine deformities: a new screening indication for blunt cerebrovascular injuries after cervical trauma? Journal of pediatric surgery, 2010, Volume: 45, Issue:12 Topics: Anticoagulants; Aspirin; Carotid Artery, Internal, Dissection; Cerebral Angiography; Cervical Atlas;	2010
GROSS CONGENITAL MALFORMATIONS IN SIBLINGS OF CHILDREN WITH GLUCOSE-6-PHOSPHATE DEHYDROGENASE-DEFICIENT ERYTHROCYTES. Australasian annals of medicine, 1964, Volume: 13 Topics: Abnormalities, Drug-Induced; Aspirin; Congenital Abnormalities; Erythrocytes; Glucosephosphate Dehyd	1964
Minor physical anomalies are not increased in the offspring of mothers with systemic lupus erythematosus. Annals of the rheumatic diseases, 2006, Volume: 65, Issue:2 Topics: Acute Disease; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Congenital Abnormalities; Fe	2006
Prescribing of NSAIDs and ASA during pregnancy; do we need to be more careful? British journal of clinical pharmacology, 2008, Volume: 65, Issue:2 Topics: Abortion, Spontaneous; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Congenit	2008
Hypothesis: antiphospholipid antibodies associated with congenital anomalies? Early pregnancy : biology and medicine : the official journal of the Society for the Investigation of Early Pregnancy, 1997, Volume: 3, Issue:2 Topics: Abortion, Habitual; Adult; Antibodies, Antiphospholipid; Antiphospholipid Syndrome; Aspirin; Congeni	1997
Aspirin pretreatment potentiates hyperthermia-induced teratogenesis in the mouse. American journal of obstetrics and gynecology, 1998, Volume: 178, Issue:2 Topics: Animals; Aspirin; Body Temperature; Bone and Bones; Congenital Abnormalities; Female; Fever; Gestati	1998
Teratogenicity of therapeutic agents. Current problems in pediatrics, 1979, Volume: 10, Issue:2 Topics: Abnormalities, Drug-Induced; Abnormalities, Radiation-Induced; Abortion, Induced; Anesthetics; Anima	1979
Congenital malformations in nonhuman primates: spontaneous and experimentally induced. The Anatomical record, 1967, Volume: 158, Issue:1 Topics: Abnormalities, Drug-Induced; Aminopterin; Animals; Aspirin; Congenital Abnormalities; Female; Haplor	1967
Alleviation of the leg abnormality in zinc-deficient chicks by histamine and by various anti-arthritic agents. The Journal of nutrition, 1968, Volume: 94, Issue:4 Topics: Amine Oxidase (Copper-Containing); Animals; Arthritis; Aspirin; Chickens; Congenital Abnormalities;	1968
Sporadic malformations in laboratory animals and their influence on drug testing. Advances in experimental medicine and biology, 1972, Volume: 27 Topics: Abnormalities, Drug-Induced; Animals; Animals, Laboratory; Aspirin; Bone and Bones; Congenital Abnor	1972
Experimental teratology and pediatrics. Paediatria Universitatis Tokyo, 1970, Volume: 18 Topics: Abnormalities, Drug-Induced; Animals; Aspirin; Congenital Abnormalities; Female; Fetal Diseases; Mam	1970

aspirin and Abnormalities, Congenital