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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Infusion at started at time of hysterotomy and stopped at neonate delivery
University California San Francisco-Labor and Delivery
San Francisco, California, United States
Number of Participants With Uterine Extension of Hysterotomy
Obstetrician determined whether the subject had an uterine extension.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Fetal Extraction Time in Seconds
Time from uterine incision to delivery (body of neonate fully extracted from uterus)
Time frame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
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Total Operative Time in Minutes
Time from uterine incision to out of room
Time frame: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
Surgical Blood Loss
Total blood loss will be measured
Time frame: During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest