An interventional study of Amniotomy and Oxytocin in Dystocia, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 206 is close to the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Observation Amniotomy Oxytocin Cesarean Section (CS)
Procedure: Amniotomy · Drug: Oxytocin · Procedure: Cesarean Section
Observation Amniotomy Oxytocin Cesarean Section (CS)
Procedure: Amniotomy · Drug: Oxytocin · Procedure: Cesarean Section
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)
Also known as: Artificial rupture of membranes
oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
Also known as: augmentation of labor
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Also known as: CS
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia
Time frame: Duration of labor (maximum 24 hours from onset of labor)
Intrapartum maternal birth injuries
This is assessed clinically at the time of labor, and includes the extent of vaginal and perineal traumas and type of repair
Time frame: Duration of labour and hospital stay (anticipated duration: 72 hours)
Primary postpartum hemorrhage
Primary postpartum hemorrhage is defined as estimated blood loss \> 500 ml following delivery and within 24 hours postpartum
Time frame: Within 24 hours of delivery
Maternal fever/postpartum infections
This is indicated by a single temperature at or above 38.0 c or 2 measurements at or above 37.5 c.
Time frame: Within 24 hours of delivery
Intrapartum fetal distress
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)
Time frame: Duration of labor (maximum 24 hours)
Birth injuries of the newborn
Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn
Time frame: The length of neonatal hospital stay (anticipated duration: 72 hours)
Neonatal distress "asphyxia"
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
Time frame: The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours)
Duration of labor in hours
This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery
Time frame: Duration of labor (maximum 24 hours)
Incidence of oxytocin use
Incidence of administration of intravenous oxytocin during labor for labor augmentation
Time frame: Duration of labor (maximum duration: 24 hours)
Incidence of instrumental delivery
Instrumental delivery includes forceps and ventouse deliveries
Time frame: Duration of labor (maximum duration: 24 hours)
Plan to share: No
Start is estimated for Aug 2022; primary completion for Jul 2023, 11 months later.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Oxytocin