acetaminophen and Congenital Fissure of the Abdominal Cavity studies

Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.

Research Excerpts

Excerpt	Relevance	Reference
"Acetaminophen is commonly used during pregnancy."	8.86	A review of the literature on the effects of acetaminophen on pregnancy outcome. ( Ang, R; Breitmeyer, J; Royal, MA; Scialli, AR, 2010)
"(1) Gastroschisis is a severe defect in the closure of the abdominal wall in newborns."	5.32	Gastroschisis and pseudoephedrine during pregnancy. ( , 2004)
"Acetaminophen is commonly used during pregnancy."	4.86	A review of the literature on the effects of acetaminophen on pregnancy outcome. ( Ang, R; Breitmeyer, J; Royal, MA; Scialli, AR, 2010)
"Compared to acetaminophen, mothers reporting NSAIDs were significantly more likely to have offspring with gastroschisis, hypospadias, cleft palate, cleft lip with cleft palate, cleft lip without cleft palate, anencephaly, spina bifida, hypoplastic left heart syndrome, pulmonary valve stenosis, and tetralogy of Fallot (aOR range, 1."	3.85	Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011. ( Ailes, EC; Anderka, M; Broussard, CS; Feldkamp, ML; Gilboa, SM; Interrante, JD; Lind, JN; Taylor, LG; Trinidad, J; Werler, MM, 2017)
"The rate of pregnant women with an opioid use disorder has risen drastically in the past 20 years, paralleling that in the general population."	2.66	Opioid Use and Misuse in Pregnancy. ( Landau, R; Shatil, B, 2020)
"(1) Gastroschisis is a severe defect in the closure of the abdominal wall in newborns."	1.32	Gastroschisis and pseudoephedrine during pregnancy. ( , 2004)
"Previous studies of gastroschisis have suggested that risk is increased for maternal use of vasoactive over-the-counter medications, including specific analgesics and decongestants."	1.31	Maternal medication use and risks of gastroschisis and small intestinal atresia. ( Mitchell, AA; Sheehan, JE; Werler, MM, 2002)

Research

Studies (8)

Authors

Clinical Trials (1)

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	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	5 (62.50)	29.6817
2010's	2 (25.00)	24.3611
2020's	1 (12.50)	2.80

Authors	Studies
Shatil, B	1
Landau, R	1
Interrante, JD	1
Ailes, EC	1
Lind, JN	1
Anderka, M	1
Feldkamp, ML	1
Werler, MM	2
Taylor, LG	1
Trinidad, J	1
Gilboa, SM	1
Broussard, CS	1
Leeder, JS	1
Scialli, AR	1
Ang, R	1
Breitmeyer, J	1
Royal, MA	1
Davies, MW	1
Kimble, RM	2
Cartwright, DW	1
Singh, SJ	1
Bourke, C	1
Cass, DT	1
Sheehan, JE	1
Mitchell, AA	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
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

Reviews

2 reviews available for acetaminophen and Congenital Fissure of the Abdominal Cavity

Other Studies

6 other studies available for acetaminophen and Congenital Fissure of the Abdominal Cavity

Article	Year
Opioid Use and Misuse in Pregnancy. Clinics in perinatology, 2020, Volume: 47, Issue:4 Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthetics, Local; Anti-Inflammatory A	2020
A review of the literature on the effects of acetaminophen on pregnancy outcome. Reproductive toxicology (Elmsford, N.Y.), 2010, Volume: 30, Issue:4 Topics: Abnormalities, Drug-Induced; Acetaminophen; Analgesics, Non-Narcotic; Animals; Antipyretics; Female;	2010

Article	Year
Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011. Annals of epidemiology, 2017, Volume: 27, Issue:10 Topics: Abnormalities, Drug-Induced; Acetaminophen; Adult; Analgesics; Analgesics, Non-Narcotic; Analgesics,	2017
Developmental pharmacogenetics: a general paradigm for application to neonatal pharmacology and toxicology. Clinical pharmacology and therapeutics, 2009, Volume: 86, Issue:6 Topics: Acetaminophen; Analgesics, Non-Narcotic; Benzhydryl Compounds; Environmental Pollutants; Female; Gas	2009
Gastroschisis and pseudoephedrine during pregnancy. Prescrire international, 2004, Volume: 13, Issue:72 Topics: Abnormalities, Drug-Induced; Acetaminophen; Adrenergic Agents; Case-Control Studies; Ephedrine; Fema	2004
Gastroschisis: ward reduction compared with traditional reduction under general anesthesia. Journal of pediatric surgery, 2005, Volume: 40, Issue:3 Topics: Abdominal Wall; Acetaminophen; Analgesics, Non-Narcotic; Anesthesia, General; Antibiotic Prophylaxis	2005
Gastroschisis reduction under analgesia in the neonatal unit. Journal of pediatric surgery, 2001, Volume: 36, Issue:11 Topics: Acetaminophen; Analgesia; Analgesics, Non-Narcotic; Gastroschisis; Hospital Units; Humans; Infant, N	2001
Maternal medication use and risks of gastroschisis and small intestinal atresia. American journal of epidemiology, 2002, Jan-01, Volume: 155, Issue:1 Topics: Acetaminophen; Adrenergic alpha-Agonists; Analgesics, Non-Narcotic; Aspirin; Canada; Ephedrine; Fema	2002