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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prolonged Second Stage of Labor

Intervention / Treatment
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* Drug: intravenous nitroglycerin


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |