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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Prolonged Second Stage of Labor

Treatments: Drug: intravenous nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT02265965

UCSF-OB-NTG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

18 participants in 2 patient groups

Intravenous Nitroglycerin

Experimental group

Description:

Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered

Treatment:

Drug: intravenous nitroglycerin

Intravenous Saline

No Intervention group

Description:

Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered