Prolonged Second Stage of Labor
Conditions
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.
Interventions
Infusion at started at time of hysterotomy and stopped at neonate delivery
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| Intravenous Saline Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered | 11 |
| Total | 18 |
Baseline characteristics
| Characteristic | Intravenous Nitroglycerin | Total | Intravenous Saline |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 18 Participants | 11 Participants |
| Age, Continuous | 35.4 years STANDARD_DEVIATION 4.1 | 34.7 years STANDARD_DEVIATION 3.6 | 34.3 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 18 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Maternal body mass index (BMI) | 22.4 kg/m^2 STANDARD_DEVIATION 3.9 | 24.2 kg/m^2 STANDARD_DEVIATION 4.2 | 25.3 kg/m^2 STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multi-racial or other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 11 Participants | 8 Participants |
| Sex: Female, Male Female | 7 Participants | 18 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 11 |
| other Total, other adverse events | 0 / 7 | 0 / 11 |
| serious Total, serious adverse events | 0 / 7 | 0 / 11 |
Outcome results
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.
Time frame: Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous Nitroglycerin | APGAR at 5 Minutes | 9 score on a scale |
| Intravenous Saline | APGAR at 5 Minutes | 9 score on a scale |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Nitroglycerin | Number of Participants With Deliveries After Which Neonate is Admitted to NICU | 1 Participants |
| Intravenous Saline | Number of Participants With Deliveries After Which Neonate is Admitted to NICU | 2 Participants |
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.
Time frame: At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Nitroglycerin | Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12 | 7 Participants |
| Intravenous Saline | Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12 | 11 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Nitroglycerin | Number of Participants With Uterine Extension of Hysterotomy | 3 Participants |
| Intravenous Saline | Number of Participants With Uterine Extension of Hysterotomy | 4 Participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Nitroglycerin | Umbilical Artery Blood pH | 7.3 pH | Standard Deviation 0 |
| Intravenous Saline | Umbilical Artery Blood pH | 7.3 pH | Standard Deviation 0 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Nitroglycerin | Fetal Extraction Time in Seconds | 104.9 seconds | Standard Deviation 33.1 |
| Intravenous Saline | Fetal Extraction Time in Seconds | 131 seconds | Standard Deviation 84.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Nitroglycerin | Surgical Blood Loss | 935.7 ml | Standard Deviation 217.4 |
| Intravenous Saline | Surgical Blood Loss | 1036.4 ml | Standard Deviation 201.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Nitroglycerin | Total Operative Time in Minutes | 68.3 minutes | Standard Deviation 22 |
| Intravenous Saline | Total Operative Time in Minutes | 74.2 minutes | Standard Deviation 21.1 |