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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Nitroglycerin | Experimental | Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
|
| Intravenous Saline | No Intervention | Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous nitroglycerin | Drug | Infusion at started at time of hysterotomy and stopped at neonate delivery |
|
| 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 |
| 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 |
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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
-
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Lucero, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California San Francisco-Labor and Delivery | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27405400 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Nitroglycerin | Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery |
| FG001 | Intravenous Saline | Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Nitroglycerin | Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery |
| BG001 | Intravenous Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Uterine Extension of Hysterotomy | Obstetrician determined whether the subject had an uterine extension. | Posted | Count of Participants | Participants | During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest |
|
Adverse event data were evaluated at 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Nitroglycerin | Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered intravenous nitroglycerin: Infusion at started at time of hysterotomy and stopped at neonate delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lucero, MD | University of California, San Francisco | 415-476-5535 | jennifer.lucero@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2017 | Apr 7, 2020 | Prot_SAP_000.pdf |
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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 |
Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Maternal body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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| Primary | Umbilical Artery Blood pH | Measure of umbilical artery blood pH | Posted | Mean | Standard Deviation | pH | At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest |
|
|
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| Primary | Number of Participants With Deliveries After Which Neonate is Admitted to NICU | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 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) | Posted | Mean | Standard Deviation | seconds | 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 | Posted | Mean | Standard Deviation | minutes | 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 | Posted | Mean | Standard Deviation | ml | During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Intravenous Saline | Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered | 0 | 11 | 0 | 11 | 0 | 11 |
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