Dystocia
Conditions
Keywords
Labor scale, Partograph, Spontaneous labor, Primigravida
Brief summary
The current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard WHO partograph, in the management of primiparous women, including CD rate, maternal and neonatal outcomes of labor.
Detailed description
Since the procedure was first introduced to clinical practice, Cesarean delivery (CD) has significantly contributed to peripartum maternal and fetal safety when appropriately indicated. Nevertheless, CD rate has significantly increased over the last two decades without parallel improvement in maternal or neonatal outcomes. Globally, one out of three pregnancies would be delivered by CD, resulting in growing surgical, obstetric and financial burden. Over years, long-term sequelae of current CD rate have become evident such as increased incidence of placenta accreta spectrum and exponential rise in CD trend, since 90% of women who had CD are susceptible to CD in future pregnancies. These concerns have triggered a global act to control CD rates within the margins of safe obstetric practice. The most common indication of CD is labor dystocia. However, the definition of labor dystocia is inconsistent, and standardization of diagnosis has been heavily investigated. The WHO partograph was established at the end of the last century to serve as a tool to recognize labor dystocia and has been universally accepted to verify CD decision However, a cochrane review by Lavender et al. revealed that role of WHO partograph, in improving clinical outcomes, is lacking. In addition, there is no evidence that any published modification of the current partograph is superior to another. The labor scale, a novel alternative to the classic partograph, was first introduced to literature in 2014. The tool was designed based on evidence-based guidelines and integrates both diagnosis and interventions to manage labor dystocia. Initial data showed that labor scale contributed to decreased incidence of CD and oxytocin administration. However, further studies are required to verify these results.
Interventions
PROCEDUREAmniotomy
Amniotomy, artificial rupture of membranes, is done with an initial delay of labor (in partograph: extension beyond the alert line, in labor scale: when progress reaches the membrane line)
DRUGOxytocin
oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
PROCEDURECesarean Section
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Pregnant women aged 18 to 45 years old with the following criteria: nulliparous, had been pregnant for 37 to 41 weeks with a singleton viable fetus, and vertex presented, and with estimated fetal weights between 2,500 and 4,500 g.
Exclusion criteria
Women with following criteria will be excluded: significant maternal medical or surgical comorbidity, previous uterine scar
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported) | Duration of labor (maximum 24 hours from onset of labor) | The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary postpartum hemorrhage | Within 24 hours of delivery | Primary postpartum hemorrhage is defined as estimated blood loss \> 500 ml following delivery and within 24 hours postpartum |
| Maternal fever/postpartum infections | Within 24 hours of delivery | This is indicated by a single temperature at or above 38.0 c or 2 measurements at or above 37.5 c. |
| Intrapartum fetal distress | Duration of labor (maximum 24 hours) | This criterion is met if cardiotocography shows signs consistent with pathological tracing as defined by NICE guidelines (persistent late or variable decelerations, prolonged bradaycardia or sinusoidal rhythm) |
| Birth injuries of the newborn | The length of neonatal hospital stay (anticipated duration: 72 hours) | Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn |
| Intrapartum maternal birth injuries | Duration of labour and hospital stay (anticipated duration: 72 hours) | This is assessed clinically at the time of labor, and includes the extent of vaginal and perineal traumas and type of repair |
| Duration of labor in hours | Duration of labor (maximum 24 hours) | This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery |
| Incidence of oxytocin use | Duration of labor (maximum duration: 24 hours) | Incidence of administration of intravenous oxytocin during labor for labor augmentation |
| Incidence of instrumental delivery | Duration of labor (maximum duration: 24 hours) | Instrumental delivery includes forceps and ventouse deliveries |
| Neonatal distress asphyxia | The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours) | This is indicated by 1 and 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to neonatal intensive care unit, length of stay and any further medical complications |
Countries
Egypt
Contacts
Primary ContactSherif Shazly, MSc
Backup ContactMohamed Abuelazm
Outcome results
None listed