Trial Outcomes & Findings for Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension (NCT NCT02265965)

NCT ID: NCT02265965

Last Updated: 2020-05-19

Results Overview

Obstetrician determined whether the subject had an uterine extension.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 18 participants
• Primary outcome timeframe: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
• Results posted on: 2020-05-19

Participant Flow

Participant milestones

Measure	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	Intravenous Saline Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Overall Study STARTED	7	11
Overall Study COMPLETED	7	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.4 years STANDARD_DEVIATION 4.1 • n=5 Participants	34.3 years STANDARD_DEVIATION 3.3 • n=7 Participants	34.7 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial or other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Maternal body mass index (BMI)	22.4 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants	25.3 kg/m^2 STANDARD_DEVIATION 4.2 • n=7 Participants	24.2 kg/m^2 STANDARD_DEVIATION 4.2 • n=5 Participants

PRIMARY outcome

Timeframe: During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Obstetrician determined whether the subject had an uterine extension.

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Number of Participants With Uterine Extension of Hysterotomy	3 Participants	4 Participants

PRIMARY outcome

Timeframe: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Measure of umbilical artery blood pH

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Umbilical Artery Blood pH	7.3 pH Standard Deviation 0	7.3 pH Standard Deviation 0

PRIMARY outcome

Timeframe: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Number of Participants With Deliveries After Which Neonate is Admitted to NICU	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12	7 Participants	11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
APGAR at 5 Minutes	9 score on a scale Interval 9.0 to 9.0	9 score on a scale Interval 8.0 to 9.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Fetal Extraction Time in Seconds	104.9 seconds Standard Deviation 33.1	131 seconds Standard Deviation 84.1

SECONDARY outcome

Timeframe: After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Time from uterine incision to out of room

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Total Operative Time in Minutes	68.3 minutes Standard Deviation 22.0	74.2 minutes Standard Deviation 21.1

SECONDARY outcome

Timeframe: During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Total blood loss will be measured

Outcome measures

Measure	Intravenous Nitroglycerin n=7 Participants 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	Intravenous Saline n=11 Participants Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered
Surgical Blood Loss	935.7 ml Standard Deviation 217.4	1036.4 ml Standard Deviation 201.4

Adverse Events

Intravenous Nitroglycerin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Lucero, MD

University of California, San Francisco

Phone: 415-476-5535

Email: jennifer.lucero@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place