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

Phase 4

Completed

Brief 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Intravenous Nitroglycerin	intravenous nitroglycerin	Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered

Primary Outcome Measures

Name	Time	Method
Number of Participants With Uterine Extension of Hysterotomy	During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest	Obstetrician determined whether the subject had an uterine extension.
Umbilical Artery Blood pH	At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest	Measure of umbilical artery blood pH
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	At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest	A cord blood base deficit more negative than negative 12 is abnormal and a sign of metabolic acidosis.
APGAR at 5 Minutes	Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest	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.

Secondary Outcome Measures

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