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

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

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.

Study Overview

• Status: Completed
• Conditions: Prolonged Second Stage of Labor
• Intervention / Treatment: Drug: intravenous nitroglycerin

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University California San Francisco-Labor and Delivery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Nitroglycerin; Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered	Drug: intravenous nitroglycerin; Infusion at started at time of hysterotomy and stopped at neonate delivery
No Intervention: Intravenous Saline; Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Uterine Extension of Hysterotomy	Obstetrician determined whether the subject had an uterine extension.	During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Umbilical Artery Blood pH	Measure of umbilical artery blood pH	At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Number of Participants With Deliveries After Which Neonate is Admitted to NICU		After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12	A cord blood base deficit more negative than negative 12 is abnormal and a sign of metabolic acidosis.	At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
APGAR at 5 Minutes	The APGAR scale is determined by evaluating the newborn baby on five simple criteria -- Appearance, Pulse, Grimace, Activity, Respiration -- on a scale from zero to two, then summing up the five values thus obtained. The resulting APGAR score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.	Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal Extraction Time in Seconds	Time from uterine incision to delivery (body of neonate fully extracted from uterus)	At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Total Operative Time in Minutes	Time from uterine incision to out of room	After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Surgical Blood Loss	Total blood loss will be measured	During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jennifer M Lucero, MD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: UCSF-OB-NTG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO