indomethacin and Enterocolitis, Pseudomembranous studies

Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.
indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis.

Enterocolitis, Pseudomembranous: An acute inflammation of the INTESTINAL MUCOSA that is characterized by the presence of pseudomembranes or plaques in the SMALL INTESTINE (pseudomembranous enteritis) and the LARGE INTESTINE (pseudomembranous colitis). It is commonly associated with antibiotic therapy and CLOSTRIDIUM DIFFICILE colonization.

Research Excerpts

Excerpt	Relevance	Reference
"This study evaluates the effects of Indomethacin (IND), Prostaglandin E1 (PGE1), and Ibuprofen (IBP) in a bowel ischemia model."	7.66	Comparative effects of indomethacin, prostaglandin E1, and ibuprofen on bowel ischemia. ( Cikrit, D; Grosfeld, JL; Gross, K; Kamman, K; Katz, S; Ross, D; Weber, TR; Wolfe, M, 1983)
" In 10-day-old rats, mucosal permeability to 51Cr EDTA was measured after subjecting the animals to 10-minute ischemia-reperfusion injury, 30 minutes of hypoxia (14% oxygen), cold stress (4 degree C for 4 minutes), and intraperitoneal indomethacin (0."	3.68	Mucosal permeability in the immature rat intestine: effects of ischemia-reperfusion, cold stress, hypoxia, and drugs. ( Langer, JC; Mumford, DA; Sohal, SS, 1993)
"This study evaluates the effects of Indomethacin (IND), Prostaglandin E1 (PGE1), and Ibuprofen (IBP) in a bowel ischemia model."	3.66	Comparative effects of indomethacin, prostaglandin E1, and ibuprofen on bowel ischemia. ( Cikrit, D; Grosfeld, JL; Gross, K; Kamman, K; Katz, S; Ross, D; Weber, TR; Wolfe, M, 1983)
" Intravenous indomethacin was administered to 67 infants with successful closure in 91% of the patients and in 83% of those with birth weights less than 1,000 g."	3.66	Parenteral indomethacin for closure of the patent ductus arteriosus. Clinical experience with 67 preterm infants. ( Alexson, CG; Harris, JP; Longfield, L; Manning, JA; Merritt, TA, 1982)
"Upper gastrointestinal haemorrhage and pseudomembranous colitis are potentially fatal manifestations of drug therapy."	2.36	Drug-induced gastrointestinal disease. ( Bramble, MG; Record, CO, 1978)
"9 percent, P = 0."	1.29	Neonatal complications after the administration of indomethacin for preterm labor. ( Clyman, RI; Cooper, BA; Kuller, JA; Merrill, J; Norton, ME, 1993)
"Allopurinol may prevent reperfusion injury by inhibiting formation of xanthine oxidase generated, oxygen-derived free radicals and may be valuable in pretreating premature infants with patent ductus arteriosus who have had an ischemic episode in whom INDO use is contemplated."	1.29	Allopurinol protects the bowel from necrosis caused by indomethacin and temporary intestinal ischemia in mice. ( Krasna, IH; Lee, RT, 1993)

Research

Studies (18)

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	10 (55.56)	18.7374
1990's	8 (44.44)	18.2507
2000's	0 (0.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Mavroudis, C	1
Cook, LN	1
Fleischaker, JW	1
Nagaraj, HS	2
Shott, RJ	1
Howe, WR	1
Gray, LA	1
Grosfeld, JL	2
Kamman, K	1
Gross, K	1
Cikrit, D	1
Ross, D	1
Wolfe, M	1
Katz, S	1
Weber, TR	1
Mullett, MD	1
Croghan, TW	1
Myerberg, DZ	1
Krall, JM	1
Neal, WA	1
Harris, JP	1
Merritt, TA	1
Alexson, CG	1
Longfield, L	1
Manning, JA	1
Marlow, N	1
Chiswick, ML	1
Cronen, PW	1
Janik, JS	1
Groff, DB	1
Passmore, JC	1
Hock, CE	1
Norton, ME	1
Merrill, J	1
Cooper, BA	1
Kuller, JA	1
Clyman, RI	1
Langer, JC	1
Sohal, SS	1
Mumford, DA	1
Major, CA	1
Lewis, DF	1
Harding, JA	1
Porto, MA	1
Garite, TJ	1
Krasna, IH	2
Lee, RT	1
Chaet, M	1
Molinari, F	1
Engle, W	1
Engum, SA	1
West, KW	1
Rescorla, FJ	1
Scherer, LR	1
Gardner, MO	1
Owen, J	1
Skelly, S	1
Hauth, JC	1
Macones, GA	1
Robinson, CA	1
Bramble, MG	1
Record, CO	1
Kim, H	1
Miller, MJ	1
Clark, DA	1
Hyman, PE	1
Abrams, CE	1
Zipser, RD	1
Osnes, M	1
Lassen, J	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

Article	Year
Indomethacin for closure of patent ductus arteriosus in prematures. Clinical pediatrics, 1982, Volume: 21, Issue:4 Topics: Clinical Trials as Topic; Double-Blind Method; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembr	1982
Increased risk of necrotizing enterocolitis in premature infants with patent ductus arteriosus treated with indomethacin. Annals of surgery, 1996, Volume: 224, Issue:3 Topics: Anti-Inflammatory Agents, Non-Steroidal; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembranous;	1996

Article	Year
Management of patent ductus arteriosus in the premature infant: indomethacin versus ligation. The Annals of thoracic surgery, 1983, Volume: 36, Issue:5 Topics: Anesthesia, Local; Birth Weight; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembranous; Female;	1983
Comparative effects of indomethacin, prostaglandin E1, and ibuprofen on bowel ischemia. Journal of pediatric surgery, 1983, Volume: 18, Issue:6 Topics: Alprostadil; Animals; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembranous; Ibuprofen; Indomet	1983
Parenteral indomethacin for closure of the patent ductus arteriosus. Clinical experience with 67 preterm infants. American journal of diseases of children (1960), 1982, Volume: 136, Issue:11 Topics: Age Factors; Birth Weight; Bronchopulmonary Dysplasia; Cerebral Hemorrhage; Ductus Arteriosus, Paten	1982
Neonatal Bartter's syndrome, indomethacin and necrotising enterocolitis. Acta paediatrica Scandinavica, 1982, Volume: 71, Issue:6 Topics: Bartter Syndrome; Consanguinity; Enterocolitis, Pseudomembranous; Humans; Hyperaldosteronism; Indome	1982
Effect of indomethacin on mesenteric circulation in mongrel dogs. Journal of pediatric surgery, 1982, Volume: 17, Issue:5 Topics: Animals; Cardiac Output; Dogs; Enterocolitis, Pseudomembranous; Indomethacin; Splanchnic Circulation	1982
Neonatal complications after the administration of indomethacin for preterm labor. The New England journal of medicine, 1993, Nov-25, Volume: 329, Issue:22 Topics: Cerebral Hemorrhage; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembranous; Female; Fetus; Huma	1993
Mucosal permeability in the immature rat intestine: effects of ischemia-reperfusion, cold stress, hypoxia, and drugs. Journal of pediatric surgery, 1993, Volume: 28, Issue:10 Topics: Animals; Animals, Newborn; Cell Membrane Permeability; Cold Temperature; Dose-Response Relationship,	1993
Tocolysis with indomethacin increases the incidence of necrotizing enterocolitis in the low-birth-weight neonate. American journal of obstetrics and gynecology, 1994, Volume: 170, Issue:1 Pt 1 Topics: Birth Weight; Chi-Square Distribution; Cohort Studies; Enterocolitis, Pseudomembranous; Female; Gest	1994
Allopurinol protects the bowel from necrosis caused by indomethacin and temporary intestinal ischemia in mice. Journal of pediatric surgery, 1993, Volume: 28, Issue:9 Topics: Allopurinol; Animals; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembranous; Gastric Lavage; In	1993
Preterm delivery after indomethacin. A risk factor for neonatal complications? The Journal of reproductive medicine, 1996, Volume: 41, Issue:12 Topics: Cohort Studies; Ductus Arteriosus, Patent; Enterocolitis, Pseudomembranous; Female; Hemorrhage; Huma	1996
Is there justification for using indomethacin in preterm labor? An analysis of neonatal risks and benefits. American journal of obstetrics and gynecology, 1997, Volume: 177, Issue:4 Topics: Cerebral Hemorrhage; Decision Support Techniques; Enterocolitis, Pseudomembranous; Female; Gestation	1997
Indomethacin administration after temporary ischemia causes bowel necrosis in mice. Journal of pediatric surgery, 1992, Volume: 27, Issue:7 Topics: Animals; Enterocolitis, Pseudomembranous; Indomethacin; Intestines; Mesenteric Arteries; Mesenteric	1992
Profile and sites of eicosanoid release in experimental necrotizing enterocolitis. Advances in prostaglandin, thromboxane, and leukotriene research, 1989, Volume: 19 Topics: Animals; Biological Assay; Disease Models, Animal; Enterocolitis, Pseudomembranous; In Vitro Techniq	1989
Enhanced urinary immunoreactive thromboxane in neonatal necrotizing enterocolitis. A diagnostic indicator of thrombotic activity. American journal of diseases of children (1960), 1987, Volume: 141, Issue:6 Topics: beta-Thromboglobulin; Enterocolitis, Pseudomembranous; Humans; Indomethacin; Infant, Newborn; Infant	1987
[Arthritis and polymyalgia in Yersinia enterocolitica infections]. Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 1974, Feb-10, Volume: 94, Issue:4 Topics: Adult; Aged; Arthritis; Diagnosis, Differential; Enterocolitis, Pseudomembranous; Erythema Nodosum;	1974

indomethacin and Enterocolitis, Pseudomembranous