Clinical trial NCT02265965: Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
Official title: Randomized Controlled Trial of IV Nitroglycerin in Cesarean Deliveries After Second Stage Arrest for the Prevention of Uterine Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prolonged Second Stage of Labor
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site.

Detailed description: Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries, uterine relaxation after tachysystole in labor, prior to external cephalic version, and during difficult fetal extraction during cesarean delivery for arrest of descent in labor. Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean delivery after second stage arrest in labor. The clinical trial will randomize women who undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension, blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery, apgar scores, admission to neonatal intensive care unit.

Eligibility criteria: Inclusion Criteria: women 37weeks or greater gestation diagnosed with second stage arrest of descent undergoing cesarean delivery -

Exclusion Criteria: elective, active phase arrest cesarean delivery, successful operative vaginal delivery

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Primary outcomes:
measure: Number of Participants With Uterine Extension of Hysterotomy
timeFrame: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
measure: Umbilical Artery Blood pH
timeFrame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
measure: Number of Participants With Deliveries After Which Neonate is Admitted to NICU
timeFrame: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
measure: Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12
timeFrame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
measure: APGAR at 5 Minutes
timeFrame: Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Secondary outcomes:
measure: Fetal Extraction Time in Seconds
timeFrame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
measure: Total Operative Time in Minutes
timeFrame: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
measure: Surgical Blood Loss
timeFrame: During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University California San Francisco-Labor and Delivery
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennifer M Lucero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isquick S, Henry D, Nakagawa S, Moghadassi M, Thiet MP, Norton M, Lucero J. The association between nitroglycerin use and adverse outcomes in women undergoing cesarean delivery in the second stage of labor. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1297-1301. doi: 10.1080/14767058.2016.1212010. Epub 2016 Aug 2.