Page last updated: 2024-11-01

nimesulide and Delayed Effects, Prenatal Exposure

nimesulide has been researched along with Delayed Effects, Prenatal Exposure in 7 studies

nimesulide: structure
nimesulide : An aromatic ether having phenyl and 2-methylsulfonamido-5-nitrophenyl as the two aryl groups.

Research Excerpts

Excerpt	Relevance	Reference
"We report a case of neonatal transient renal failure after maternal ingestion of diclofenac, paracetamol, and nimesulide during pregnancy."	3.72	In utero exposure to nonsteroidal anti-inflammatory drugs: neonatal renal failure. ( Benini, D; Cuzzolin, L; Fanos, V; Tatò, L, 2004)
" Her mother ingested therapeutic doses of nimesulide, a non-steroidal anti-inflammatory (cyclo-oxygenase-2 inhibitor) drug, during the last 2 weeks of pregnancy."	3.70	Perinatal vasoconstrictive renal insufficiency associated with maternal nimesulide use. ( Holcberg, G; Landau, D; Marks, K; Polacheck, H; Shelef, I, 1999)
"We report a case of neonatal renal failure associated with maternal ingestion of Nimuselide in the third trimester of pregnancy."	1.33	Renal tubular dysgenesis associated with in utero exposure to Nimuselide. ( Ali, US; Andankar, P; Dubhalish, V; Khubchandani, S; Padhye, B; Parekhji, S, 2006)

Research

Studies (7)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (28.57)	18.2507
2000's	5 (71.43)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Benini, D	1
Fanos, V	1
Cuzzolin, L	1
Tatò, L	1
Magnani, C	1
Moretti, S	1
Ammenti, A	1
Sciacca, P	1
Romeo, MG	1
Falsaperla, R	1
Mattia, C	1
Betta, P	1
Tornambene, G	1
Distefano, G	1
Ali, US	1
Khubchandani, S	1
Andankar, P	1
Parekhji, S	1
Dubhalish, V	1
Padhye, B	1
Manganaro, M	1
Papoff, P	1
Cicchetti, R	1
Caresta, E	1
Moretti, C	1
Peruzzi, L	1
Gianoglio, B	1
Porcellini, MG	1
Coppo, R	1
Landau, D	1
Shelef, I	1
Polacheck, H	1
Marks, K	1
Holcberg, G	1

Clinical Trials (1)

Trial Overview

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]

Trial Outcomes

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

- Early preterm delivery (<34 weeks) (NCT02409680)
Timeframe: At delivery

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

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

- Birth weight <2500g (NCT02409680)
Timeframe: At delivery

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

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

- Birth weight <1500g (NCT02409680)
Timeframe: At delivery

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

Fetal Outcome 4 - Incidence of Fetal Loss

- Incidence of Fetal Loss (NCT02409680)
Timeframe: At delivery

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

Fetal Outcome 5 - Incidence of Spontaneous Abortion

- Incidence of Spontaneous Abortion (NCT02409680)
Timeframe: At delivery

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

Fetal Outcome 6 - Incidence of All Stillbirth

- Incidence of All stillbirth (NCT02409680)
Timeframe: At delivery

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

Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy

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

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

Incidence of Hypertensive Disorders of Pregnancy

- 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)

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

Incidence of Perinatal Mortality

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

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

Incidence of Preterm Birth

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

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

Incidence of Small for Gestational Age (SGA)

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

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

Maternal Outcome 1 - Incidence of Vaginal Bleeding

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

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

Maternal Outcome 2 - Incidence of Antepartum Hemorrhage

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

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

Maternal Outcome 3 - Incidence of Postpartum Hemorrhage

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

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

Maternal Outcome 4 - Incidence of Maternal Mortality

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

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

Maternal Outcome 5 - Incidence of Late Abortion

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

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

Maternal Outcome 6 - Change in Maternal Hemoglobin

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.

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

Maternal Outcome 7 - Incidence of Preterm, Preeclampsia

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

Intervention	Participants (Count of Participants)
Intervention Arm	8
Placebo Arm	21

Other Studies

7 other studies available for nimesulide and Delayed Effects, Prenatal Exposure

Article	Year
In utero exposure to nonsteroidal anti-inflammatory drugs: neonatal renal failure. Pediatric nephrology (Berlin, Germany), 2004, Volume: 19, Issue:2 Topics: Acetaminophen; Acute Kidney Injury; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Fema	2004
Neonatal chronic renal failure associated with maternal ingestion of Nimesulide as analgesic. European journal of obstetrics, gynecology, and reproductive biology, 2004, Oct-15, Volume: 116, Issue:2 Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Female; Humans; Infant; I	2004
[Transient right ventricular hypertrophy in a newborn infant exposed in utero to nimesulide]. Minerva pediatrica, 2005, Volume: 57, Issue:5 Topics: Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ductus Arteriosus; Female; Follo	2005
Renal tubular dysgenesis associated with in utero exposure to Nimuselide. Pediatric nephrology (Berlin, Germany), 2006, Volume: 21, Issue:2 Topics: Abnormalities, Drug-Induced; Cyclooxygenase Inhibitors; Female; Humans; Infant, Newborn; Kidney Tubu	2006
Hypoglycaemia in an infant with severe pulmonary hypertension after prenatal exposure to nimesulide: coincidence or side effect? Acta paediatrica (Oslo, Norway : 1992), 2007, Volume: 96, Issue:3 Topics: Cyclooxygenase Inhibitors; Female; Humans; Hypertension, Pulmonary; Hypoglycemia; Infant, Newborn; P	2007
Neonatal end-stage renal failure associated with maternal ingestion of cyclo-oxygenase-type-1 selective inhibitor nimesulide as tocolytic. Lancet (London, England), 1999, Nov-06, Volume: 354, Issue:9190 Topics: Adult; Cyclooxygenase Inhibitors; Female; Humans; Infant, Newborn; Kidney Failure, Chronic; Obstetri	1999
Perinatal vasoconstrictive renal insufficiency associated with maternal nimesulide use. American journal of perinatology, 1999, Volume: 16, Issue:9 Topics: Acute Kidney Injury; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Cough; Female; Feve	1999