Obstetric Labor, Parturition, Pregnancy
Conditions
Keywords
STAN, Fetal monitoring, Fetal acidosis, Fetal heart rate monitoring, Perinatology
Brief summary
The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.
Detailed description
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN): Fetal ECG analysis of the ST segment (STAN) is now FDA-approved and clinically available in the United States as an adjunct for the interpretation of electronic fetal heart rate patterns. There have been a number of randomized controlled trials as well as observational studies in Europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. However, despite these endorsements, there remain concerns with the application of the technology to the United States. None of the randomized trials were performed in the United States where patient case-mix and obstetrical practice, such as the use of fetal scalp pH, differ from Europe, which may affect the impact of this technology on perinatal outcomes. Moreover, the results of the European studies are not uniformly positive. This protocol describes a randomized controlled trial of the STAN technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.
Interventions
DEVICEfetal STAN monitor
The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG.
Sponsors
Neoventa Medical
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The George Washington University Biostatistics Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
The study is a randomized, controlled clinical trial of 11,000 women in labor at \> 36.0 weeks gestation randomized to one of two groups using the STAN S31 system: * Fetal STAN electrode inserted and data available to caregivers (open device group) * Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)
Intervention model description
The study is a randomized, controlled clinical trial of 11,000 women in labor at \> 36.0 weeks gestation randomized to one of two groups using the STAN S31 system: * Fetal STAN electrode inserted and data available to caregivers (open device group) * Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Singleton, cephalic pregnancy * Gestational age at least 36 weeks, 1 day * Cervical dilation of at least 2 cm and no more than 7 cm * Ruptured membranes
Exclusion criteria
* Multifetal gestation * Planned cesarean delivery * Need for immediate delivery * Absent variability or sinusoidal pattern at any time, or a Category II fetal heart rate pattern with absent variability in the last 20 minutes before randomization * Inability to obtain or maintain an adequate signal within 3 trials of electrode placements * Occurrence of any ST event during attempt to obtain adequate signal * Patient pushing in the first stage of labor * Known major fetal anomaly or fetal demise * Previous uterine surgery * Placenta previa on admission * Maternal fever greater than or equal to 38 C or 100.4 F * Active HSV infection * Known HIV or hepatitis infection * Other maternal and fetal contraindications for using the STAN monitor * Enrollment in another labor study * Participation in this trial in a previous pregnancy * No certified or authorized provider available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary Composite Outcome | From Delivery through 1 month of age | Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score \<=3 at 5 minutes, neonatal seizure, umbilical artery blood pH \<= 7.05 with base deficit \>=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy |
| Number of Intrapartum Fetal Deaths (Primary Outcome Component) | During labor and through delivery of the baby | Death of the fetus during the intrapartum period. |
| Number of Neonatal Deaths (Primary Outcome Component) | Delivery through1 month of age | Death of the newborn between delivery and1 month of age |
| Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) | 5 minutes after delivery | The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. The lowest score is 0, the highest score is 10. |
| Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) | Birth through hospital discharge | Number of infants who experienced Neonatal Seizure |
| Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component) | Delivery | Umbilical-artery blood pH \< = 7.05 and base deficit in extracellular fluid \> = 12 mmol/liter |
| Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) | Delivery | Neonatal intubation for ventilation in the delivery room |
| Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) | Delivery through hospital discharge | Neonatal encephalopathy experienced between delivery and discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Postpartum Endometritis | Delivery through hospital discharge | Postpartum endometritis |
| Median Length of Hospital Stay | From admission to labor and delivery through hospital discharge | Days of stay in the hospital |
| Number of Participants With Chorioamnionitis | Any time from Randomization through Delivery | Chorioamnionitis |
| Median Apgar Score at 5 Minutes | 5 minutes after Delivery | The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. |
| Number of Infants With a Major Congenital Malformation | Delivery | Major congenital malformation |
| Number of Infants Admitted to Special Care Nursery | Delivery and 1 month of age | Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery) |
| Number of Infants With Meconium Aspiration Syndrome | Delivery through discharge | Meconium aspiration syndrome |
| Number of Participants by Delivery Method | Delivery | Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean |
| Number of Participants by Indication for Cesarean | At any time from randomization through delivery | indication for the cesarean delivery |
| Number of Participants With an Indication for Forceps or Vacuum Delivery | During labor through delivery | Indication for delivery by forceps or vacuum |
| Median Duration of Labor Post-randomization | Onset of Labor through delivery | Duration of labor in hours after randomization through delivery |
| Number of Neonates With Shoulder Dystocia During Delivery | Delivery | Presence of shoulder dystocia during delivery |
| Number of Participants Who Had a Postpartum Blood Transfusion | Delivery through hospital discharge | Blood transfusion from delivery and through hospital stay until discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Group S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines | 5,532 |
| Masked Group The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife. | 5,576 |
| Total | 11,108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined to continue participation | 8 | 13 |
| Overall Study | Ineligible | 0 | 2 |
| Overall Study | Physician Decision | 22 | 24 |
| Overall Study | Randomization error | 5 | 1 |
| Overall Study | Staff error | 2 | 1 |
| Overall Study | Technical problems | 7 | 6 |
Baseline characteristics
| Characteristic | Open Group | Total | Masked Group |
|---|---|---|---|
| Age, Continuous | 27.4 years STANDARD_DEVIATION 5.9 | 27.3 years STANDARD_DEVIATION 5.8 | 27.2 years STANDARD_DEVIATION 5.8 |
| Body-mass index before pregnancy | 27.4 kg/m^2 STANDARD_DEVIATION 7.2 | 27.4 kg/m^2 STANDARD_DEVIATION 7.1 | 27.4 kg/m^2 STANDARD_DEVIATION 7 |
| Cervical dilation at randomization | 5 centimeters | 5 centimeters | 5 centimeters |
| Educational level | 12.8 years STANDARD_DEVIATION 2.6 | 12.8 years STANDARD_DEVIATION 2.6 | 12.8 years STANDARD_DEVIATION 2.7 |
| Nulliparous | 2354 Participants | 4727 Participants | 2373 Participants |
| Race/Ethnicity, Customized Black | 1326 Participants | 2676 Participants | 1350 Participants |
| Race/Ethnicity, Customized Other | 909 Participants | 1854 Participants | 945 Participants |
| Race/Ethnicity, Customized White | 3297 Participants | 6578 Participants | 3281 Participants |
| Sex: Female, Male Female | 5532 Participants | 11108 Participants | 5576 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of labor Induced | 3273 Participants | 6538 Participants | 3265 Participants |
| Type of labor Spontaneous | 2259 Participants | 4570 Participants | 2311 Participants |
| Week of pregnancy at randomization | 39.4 weeks STANDARD_DEVIATION 1.2 | 39.4 weeks STANDARD_DEVIATION 1.2 | 39.4 weeks STANDARD_DEVIATION 1.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5,532 | 0 / 5,576 |
| serious Total, serious adverse events | 35 / 5,532 | 21 / 5,576 |
Outcome results
Primary
Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)
Neonatal encephalopathy experienced between delivery and discharge
Time frame: Delivery through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) | 4 Participants |
| Masked Group | Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) | 5 Participants |
p-value: 195% CI: [0.22, 3]Fisher Exact
Primary
Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)
Number of infants who experienced Neonatal Seizure
Time frame: Birth through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) | 3 Participants |
| Masked Group | Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) | 4 Participants |
p-value: 195% CI: [0.17, 3.38]Fisher Exact
Primary
Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. The lowest score is 0, the highest score is 10.
Time frame: 5 minutes after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) | 17 Participants |
| Masked Group | Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) | 6 Participants |
p-value: 0.0295% CI: [1.13, 7.24]Chi-squared
Primary
Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)
Umbilical-artery blood pH \< = 7.05 and base deficit in extracellular fluid \> = 12 mmol/liter
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component) | 3 Participants |
| Masked Group | Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component) | 8 Participants |
p-value: 0.1395% CI: [0.1, 1.41]Chi-squared
Primary
Number of Intrapartum Fetal Deaths (Primary Outcome Component)
Death of the fetus during the intrapartum period.
Time frame: During labor and through delivery of the baby
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Intrapartum Fetal Deaths (Primary Outcome Component) | 0 Participants |
| Masked Group | Number of Intrapartum Fetal Deaths (Primary Outcome Component) | 0 Participants |
Primary
Number of Neonatal Deaths (Primary Outcome Component)
Death of the newborn between delivery and1 month of age
Time frame: Delivery through1 month of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Neonatal Deaths (Primary Outcome Component) | 3 Participants |
| Masked Group | Number of Neonatal Deaths (Primary Outcome Component) | 1 Participants |
p-value: 0.3795% CI: [0.31, 29.1]Fisher Exact
Primary
Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)
Neonatal intubation for ventilation in the delivery room
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) | 42 Participants |
| Masked Group | Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) | 27 Participants |
p-value: 0.0795% CI: [0.97, 2.54]Chi-squared
Primary
Number of Participants With Primary Composite Outcome
Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score \<=3 at 5 minutes, neonatal seizure, umbilical artery blood pH \<= 7.05 with base deficit \>=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy
Time frame: From Delivery through 1 month of age
Population: Umbilical cord artery blood was not able to be obtained from all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Participants With Primary Composite Outcome | 52 Participants |
| Masked Group | Number of Participants With Primary Composite Outcome | 40 Participants |
Comparison: Analysis on primary composite outcome as a whole.p-value: 0.295% CI: [0.87, 1.98]Chi-squared
Secondary
Median Apgar Score at 5 Minutes
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score.
Time frame: 5 minutes after Delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Open Group | Median Apgar Score at 5 Minutes | 9 score on a scale |
| Masked Group | Median Apgar Score at 5 Minutes | 9 score on a scale |
p-value: 0.54Wilcoxon (Mann-Whitney)
Secondary
Median Duration of Labor Post-randomization
Duration of labor in hours after randomization through delivery
Time frame: Onset of Labor through delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Open Group | Median Duration of Labor Post-randomization | 3.8 Hours |
| Masked Group | Median Duration of Labor Post-randomization | 3.9 Hours |
p-value: 0.32Wilcoxon (Mann-Whitney)
Secondary
Median Length of Hospital Stay
Days of stay in the hospital
Time frame: From admission to labor and delivery through hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Open Group | Median Length of Hospital Stay | 2 Days |
| Masked Group | Median Length of Hospital Stay | 2 Days |
p-value: 0.77Wilcoxon (Mann-Whitney)
Secondary
Number of Infants Admitted to Special Care Nursery
Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery)
Time frame: Delivery and 1 month of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants Admitted to Special Care Nursery | 498 Participants |
| Masked Group | Number of Infants Admitted to Special Care Nursery | 470 Participants |
p-value: 0.28Chi-squared
Secondary
Number of Infants With a Major Congenital Malformation
Major congenital malformation
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants With a Major Congenital Malformation | 38 Participants |
| Masked Group | Number of Infants With a Major Congenital Malformation | 23 Participants |
p-value: 0.05Chi-squared
Secondary
Number of Infants With Meconium Aspiration Syndrome
Meconium aspiration syndrome
Time frame: Delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Infants With Meconium Aspiration Syndrome | 20 Participants |
| Masked Group | Number of Infants With Meconium Aspiration Syndrome | 20 Participants |
p-value: 0.98Chi-squared
Secondary
Number of Neonates With Shoulder Dystocia During Delivery
Presence of shoulder dystocia during delivery
Time frame: Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Neonates With Shoulder Dystocia During Delivery | 141 Participants |
| Masked Group | Number of Neonates With Shoulder Dystocia During Delivery | 158 Participants |
p-value: 0.35Chi-squared
Secondary
Number of Participants by Delivery Method
Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean
Time frame: Delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Group | Number of Participants by Delivery Method | Vacuum-Assisted | 201 Participants |
| Open Group | Number of Participants by Delivery Method | Forceps | 128 Participants |
| Open Group | Number of Participants by Delivery Method | Cesarean | 934 Participants |
| Open Group | Number of Participants by Delivery Method | Spontaneous | 4269 Participants |
| Masked Group | Number of Participants by Delivery Method | Cesarean | 901 Participants |
| Masked Group | Number of Participants by Delivery Method | Spontaneous | 4348 Participants |
| Masked Group | Number of Participants by Delivery Method | Forceps | 103 Participants |
| Masked Group | Number of Participants by Delivery Method | Vacuum-Assisted | 224 Participants |
p-value: 0.17Chi-squared
Secondary
Number of Participants by Indication for Cesarean
indication for the cesarean delivery
Time frame: At any time from randomization through delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Group | Number of Participants by Indication for Cesarean | Fetal Indication | 287 Participants |
| Open Group | Number of Participants by Indication for Cesarean | Dystocia | 621 Participants |
| Open Group | Number of Participants by Indication for Cesarean | Other | 26 Participants |
| Masked Group | Number of Participants by Indication for Cesarean | Fetal Indication | 298 Participants |
| Masked Group | Number of Participants by Indication for Cesarean | Dystocia | 583 Participants |
| Masked Group | Number of Participants by Indication for Cesarean | Other | 20 Participants |
p-value: 0.45Chi-squared
Secondary
Number of Participants Experiencing Postpartum Endometritis
Postpartum endometritis
Time frame: Delivery through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Participants Experiencing Postpartum Endometritis | 71 Participants |
| Masked Group | Number of Participants Experiencing Postpartum Endometritis | 88 Participants |
p-value: 0.19Chi-squared
Secondary
Number of Participants Who Had a Postpartum Blood Transfusion
Blood transfusion from delivery and through hospital stay until discharge
Time frame: Delivery through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Participants Who Had a Postpartum Blood Transfusion | 80 Participants |
| Masked Group | Number of Participants Who Had a Postpartum Blood Transfusion | 74 Participants |
p-value: 0.59Chi-squared
Secondary
Number of Participants With an Indication for Forceps or Vacuum Delivery
Indication for delivery by forceps or vacuum
Time frame: During labor through delivery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Group | Number of Participants With an Indication for Forceps or Vacuum Delivery | Fetal indication | 225 Participants |
| Open Group | Number of Participants With an Indication for Forceps or Vacuum Delivery | Other | 9 Participants |
| Open Group | Number of Participants With an Indication for Forceps or Vacuum Delivery | Dystocia | 95 Participants |
| Masked Group | Number of Participants With an Indication for Forceps or Vacuum Delivery | Fetal indication | 218 Participants |
| Masked Group | Number of Participants With an Indication for Forceps or Vacuum Delivery | Dystocia | 101 Participants |
| Masked Group | Number of Participants With an Indication for Forceps or Vacuum Delivery | Other | 8 Participants |
Secondary
Number of Participants With Chorioamnionitis
Chorioamnionitis
Time frame: Any time from Randomization through Delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Group | Number of Participants With Chorioamnionitis | 286 Participants |
| Masked Group | Number of Participants With Chorioamnionitis | 269 Participants |
p-value: 0.4Chi-squared