NCT02265965

Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension

Randomized Controlled Trial of IV Nitroglycerin in Cesarean Deliveries After Second Stage Arrest for the Prevention of Uterine Extension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prolonged Second Stage of Labor

Interventions

Type	Name	Description
DRUG	intravenous nitroglycerin	Infusion at started at time of hysterotomy and stopped at neonate delivery

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-10-16
• Last updated: 2020-05-19
• Results posted: 2020-05-19

Locations

1 site across 1 country: United States