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

Condition(s) targeted: Prolonged Second Stage of Labor

Intervention: intravenous nitroglycerin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of California, San Francisco

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Primary outcome:

Uterine Extension of Hysterotomy

Umbilical artery blood pH

NICU admission

Umbilical artery base deficit

Number of neonates with Apgars <7

Secondary outcome:

Fetal extraction time in seconds

Total operative time in minutes

Surgical blood loss

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.

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

-

University California San Francisco-Labor and Delivery, San Francisco, California 94143, United States; Not yet recruiting
Jennifer M Lucero, MD, Phone: 415-476-5535, Email: luceroj@anesthesia.ucsf.edu
Mari-Paule Thiet, MD, Phone: 415-476-7978, Email: thietm@obgyn.ucsf.edu

Starting date: August 2015
Last updated: July 17, 2015