N/A N=11,108 Randomized Single-blind Prevention

Fetal ST Segment and T Wave Analysis in Labor

Pregnancy · Obstetric Labor · Parturition

Bottom Line

View on ClinicalTrials.gov: NCT01131260 ↗

Enrolled (actual)

11,108

Serious AEs

0.5%

Results posted

Apr 2019

Primary outcome: Primary: Number of Participants With Primary Composite Outcome — 52; 40 Participants — p=0.20

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: fetal STAN monitor (Device)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: The George Washington University Biostatistics Center
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Primary Composite Outcome	52; 40	0.20
PRIMARY Number of Intrapartum Fetal Deaths (Primary Outcome Component)	0; 0	—
PRIMARY Number of Neonatal Deaths (Primary Outcome Component)	3; 1	0.37
PRIMARY Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)	17; 6	0.02 sig
PRIMARY Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)	3; 4	1.0
PRIMARY Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)	3; 8	0.13
PRIMARY Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)	42; 27	0.07
PRIMARY Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)	4; 5	1.0
SECONDARY Number of Participants by Delivery Method	4269; 4348; 128; 103; 201; 224	.17
SECONDARY Number of Participants by Indication for Cesarean	287; 298; 621; 583; 26; 20	0.45
SECONDARY Number of Participants With an Indication for Forceps or Vacuum Delivery	225; 218; 95; 101; 9; 8	—
SECONDARY Median Duration of Labor Post-randomization	3.8; 3.9	.32
SECONDARY Number of Neonates With Shoulder Dystocia During Delivery	141; 158	0.35
SECONDARY Number of Participants With Chorioamnionitis	286; 269	0.40
SECONDARY Number of Participants Who Had a Postpartum Blood Transfusion	80; 74	0.59
SECONDARY Number of Participants Experiencing Postpartum Endometritis	71; 88	.19
SECONDARY Median Length of Hospital Stay	2; 2	0.77
SECONDARY Number of Infants Admitted to Special Care Nursery	498; 470	0.28
SECONDARY Median Apgar Score at 5 Minutes	9; 9	0.54
SECONDARY Number of Infants With Meconium Aspiration Syndrome	20; 20	0.98
SECONDARY Number of Infants With a Major Congenital Malformation	38; 23	.05

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01131260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.