Overview

This trial is active, not recruiting.

Condition dystocia
Treatments amniotomy, oxytocin, cesarean section
Sponsor Assiut University
Start date July 2015
End date June 2016
Trial size 120 participants
Trial identifier NCT02486822, IRB00008718 - SLiP

Summary

This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Observation Amniotomy Oxytocin Cesarean Section (CS)
amniotomy Artificial rupture of membranes
Amniotomy, artificial rupture of membranes, is done with initial delay of labor (in partograph: extension beyond alert line, in labor scale: when progress reaches the membrane line)
oxytocin augmentation of labor
Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
cesarean section CS
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
(Active Comparator)
Observation Amniotomy Oxytocin Cesarean Section (CS)
amniotomy Artificial rupture of membranes
Amniotomy, artificial rupture of membranes, is done with initial delay of labor (in partograph: extension beyond alert line, in labor scale: when progress reaches the membrane line)
oxytocin augmentation of labor
Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
cesarean section CS
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)

Primary Outcomes

Measure
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
time frame: Time of labor (maximum 24 hours)

Secondary Outcomes

Measure
Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)
time frame: Time of labor (maximum 24 hours)
Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported)
time frame: Time of labour and hospital stay (expected average 72 hours)
Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions
time frame: The length of hospital stay (expected average 72 hours)
Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture
time frame: The length of hospital stay (expected average 72 hours)
Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring
time frame: Duration of labor (maximum 24 hours)
birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management )
time frame: The length of hospital stay (expected average 1 week)
Neonatal distress "asphyxia" (as reported 1 & 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to NICU, length of stay and any further medical complications)
time frame: The length of hospital/NICU stay (expected average 1 week)

Eligibility Criteria

Female participants from 18 years up to 35 years old.

Inclusion Criteria: - Primigravida - 38 - 42 weeks of gestation - Singleton pregnancy - Vertex presentation - Spontaneous labour - Average estimated fetal weight (2500 - 3800 gram) Exclusion Criteria: - Maternal medical or surgical major co-morbidity - Previous uterine scar - Induction of labor - Premature rupture of membranes

Additional Information

Official title The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph
Principal investigator Sherif AM Shazly, MBBCh,MSc
Description After many centuries through which vaginal delivery (VD) had been the only safe route of birth, Cesarean section (CS) emerged as an alternative in emergency situations. CS has gradually become an appealing option for both the mother and the obstetrician and its indications increase while CS was proving safety; the rate of CS in U.S.A increased by about 50% within 10 years around the beginning of the current century. However, the increasing prevalence of CS raises questions about the impact of this trend on maternal morbidity, mortality as well as its economic burden. Accordingly, recent guidelines have been directed to revise practice-base CS indications to only situations when CS is truly beneficial to the mother and/or the fetus. Of these indications, the most reported one was labour dystocia. The WHO partograph is a famous chart that is commonly used to observe uncomplicated labour and is almost an objective approach to guide interference. Unfortunately, the rule of the partograph in reducing the incidence of CS is questionable. Furthermore, the design of the partograph is not exactly perfect to present the process of labour. For these reasons, the labour scale was designed as a novel follow-up chart during labour. The chart considered more objective and timed management of labour with more flexible range of time based on recent evidence. A previous pilot study on 77 women suggested that the labour scale may be a good alternative to the current partograph. This study is the first randomized trial the compares the 2 charts as regards the rate of CS, maternal and neonatal health outcomes and both patient and obstetrician satisfaction. In this clinical trial, the investigators aim to compare the labour scale to the traditional WHO partograph in terms of incidence of labor dystocia and CS as well as maternal and neonatal outcomes
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Assiut University.