nimesulide and Labor, Premature studies

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

Research Excerpts

Excerpt	Relevance	Reference
" This case report shows a pregnancy with anhydramnios and maternal thrombocytopenia, as side effects of the nimesulide therapy."	7.72	Anhydramnios and maternal thrombocytopenia after prolonged use of nimesulide. ( Bracciante, R; Manganelli, F; Paternoster, DM; Snijders, D; Torrisi, A, 2003)
"Nimesulide was prescribed for postoperative preterm labor prophylaxis."	5.31	Severe oligohydramnios induced by cyclooxygenase-2 inhibitor nimesulide. ( Holmes, RP; Stone, PR, 2000)
" This case report shows a pregnancy with anhydramnios and maternal thrombocytopenia, as side effects of the nimesulide therapy."	3.72	Anhydramnios and maternal thrombocytopenia after prolonged use of nimesulide. ( Bracciante, R; Manganelli, F; Paternoster, DM; Snijders, D; Torrisi, A, 2003)
"We report pregnancy outcome and fetal side effects in women at high risk of second trimester loss and early preterm delivery treated with nimesulide."	3.72	Experience of the use of nimesulide, a cyclo-oxygenase-2 selective prostaglandin synthesis inhibitor, in the prevention of preterm labour in 44 high-risk cases. ( Bennett, PR; Groom, KM; Sawdy, RJ, 2004)
"Premature labor was induced in ewes with long-term catheterized fetuses by infusion of dexamethasone (1 mg/d) starting at 138 +/- 1 days' gestation."	1.31	Inhibition of premature labor in sheep by a combined treatment of nimesulide, a prostaglandin synthase type 2 inhibitor, and atosiban, an oxytocin receptor antagonist. ( Grigsby, PL; Hirst, JJ; Jenkin, G; Poore, KR, 2000)
"Nimesulide was prescribed for postoperative preterm labor prophylaxis."	1.31	Severe oligohydramnios induced by cyclooxygenase-2 inhibitor nimesulide. ( Holmes, RP; Stone, PR, 2000)
"Nimesulide therapy was continued for eight days (5-16) and was associated with a prolongation of pregnancy of 27 days (6-69)."	1.31	Can a cyclo-oxygenase type-2 selective tocolytic agent avoid the fetal side effects of indomethacin? ( Bellini, P; Ghidini, A; Locatelli, A; Strobelt, N; Vergani, P, 2001)
"In 2 nimesulide-treated ewes labor did not progress to delivery despite membrane rupture."	1.30	Efficacy of the selective prostaglandin synthase type 2 inhibitor nimesulide in blocking basal prostaglandin production and delaying glucocorticoid-induced premature labor in sheep. ( Hirst, JJ; Poore, KR; Young, IR, 1999)
"Nimesulide was effective in antagonizing alcohol-induced preterm labor."	1.30	Progesterone and prostaglandin H synthase-2 involvement in alcohol-induced preterm birth in mice. ( Cook, JL; Olson, DM; Randall, CL; White, NM; Zaragoza, DB, 1999)

Research

Studies (11)

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	4 (36.36)	18.2507
2000's	7 (63.64)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Paternoster, DM	1
Snijders, D	1
Manganelli, F	1
Torrisi, A	1
Bracciante, R	1
Sawdy, RJ	2
Lye, S	1
Fisk, NM	1
Bennett, PR	3
Loudon, JA	1
Groom, KM	2
Sawdy, R	1
Slater, D	1
Fisk, N	1
Edmonds, DK	1
Bennett, P	1
Poore, KR	2
Young, IR	1
Hirst, JJ	2
Peruzzi, L	1
Gianoglio, B	1
Porcellini, MG	1
Coppo, R	1
Cook, JL	1
Zaragoza, DB	1
White, NM	1
Randall, CL	1
Olson, DM	1
Grigsby, PL	1
Jenkin, G	1
Holmes, RP	1
Stone, PR	1
Locatelli, A	1
Vergani, P	1
Bellini, P	1
Strobelt, N	1
Ghidini, A	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
Anhydramnios and maternal thrombocytopenia after prolonged use of nimesulide. European journal of obstetrics, gynecology, and reproductive biology, 2003, May-01, Volume: 108, Issue:1 Topics: Adult; Cyclooxygenase Inhibitors; Female; Gestational Age; Humans; Obstetric Labor, Premature; Oligo	2003
Experience of the use of nimesulide, a cyclo-oxygenase-2 selective prostaglandin synthesis inhibitor, in the prevention of preterm labour in 44 high-risk cases. Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2004, Volume: 24, Issue:3 Topics: Adult; Cervix Uteri; Cyclooxygenase Inhibitors; Dose-Response Relationship, Drug; Female; Humans; Ob	2004
Use of a cyclo-oxygenase type-2-selective non-steroidal anti-inflammatory agent to prevent preterm delivery. Lancet (London, England), 1997, Jul-26, Volume: 350, Issue:9073 Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclo	1997
Efficacy of the selective prostaglandin synthase type 2 inhibitor nimesulide in blocking basal prostaglandin production and delaying glucocorticoid-induced premature labor in sheep. American journal of obstetrics and gynecology, 1999, Volume: 180, Issue:5 Topics: Animals; Cyclooxygenase Inhibitors; Dexamethasone; Dinoprost; Dinoprostone; Electromyography; Female	1999
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
Progesterone and prostaglandin H synthase-2 involvement in alcohol-induced preterm birth in mice. Alcoholism, clinical and experimental research, 1999, Volume: 23, Issue:11 Topics: Animals; Central Nervous System Depressants; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxy	1999
Inhibition of premature labor in sheep by a combined treatment of nimesulide, a prostaglandin synthase type 2 inhibitor, and atosiban, an oxytocin receptor antagonist. American journal of obstetrics and gynecology, 2000, Volume: 183, Issue:3 Topics: Animals; Arteries; Blood Glucose; Cyclooxygenase Inhibitors; Dexamethasone; Dinoprost; Dinoprostone;	2000
Severe oligohydramnios induced by cyclooxygenase-2 inhibitor nimesulide. Obstetrics and gynecology, 2000, Volume: 96, Issue:5 Pt 2 Topics: Adult; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Female; Humans; Iso	2000
Can a cyclo-oxygenase type-2 selective tocolytic agent avoid the fetal side effects of indomethacin? BJOG : an international journal of obstetrics and gynaecology, 2001, Volume: 108, Issue:3 Topics: Administration, Oral; Adult; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitor	2001

nimesulide and Labor, Premature