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

Prolonged Second Stage of Labor Clinical Trial

— NITRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265965
• Other study ID #: UCSF-OB-NTG
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: May 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Prolonged Second Stage of Labor

Intervention

Drug:
• intravenous nitroglycerin
Infusion at started at time of hysterotomy and stopped at neonate delivery

Locations

Country	Name	City	State
United States	University California San Francisco-Labor and Delivery	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):129 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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