Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-06-08
Brief Title:
Ultrasound Prediction of POPP in Active Labor
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Ultrasound Prediction of Persistent Occiput Posterior Position in Active Labor a Multicentric Prospective Cross-sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPP-UP
Brief Summary:
Persistent occiput posterior position POPP represents a relevant risk factor for various adverse outcomes prolonged labor higher incidence of operative delivery andor cesarean section for non-reassuring fetal conditions higher incidence of high-grade perineal tears OASIS For such reasons labor with POPP needs particular and non-routinary attention
Hence it is important to diagnose in advance fetuses who present POPP to assure more adequate assistance in labor Furthermore digital examination shows a lower detection rate for such condition if compared to ultrasound in labor
This multicenter prospective cross-sectional interventional study aims to evaluate the occiput position and the descent of the fetal head at the beginning of active labor to predict POPP at delivery All the participants will be subjected to transabdominal and transperineal ultrasound at the beginning of active labor between 3 and 8 cm of cervical dilatation to evaluate the position of the fetal head and its descent At the delivery the position of the fetal head and the features of the second stage of the labor will be recorded
Hence it is important to diagnose in advance fetuses who present POPP to assure more adequate assistance in labor Furthermore digital examination shows a lower detection rate for such condition if compared to ultrasound in labor
This multicenter prospective cross-sectional interventional study aims to evaluate the occiput position and the descent of the fetal head at the beginning of active labor to predict POPP at delivery All the participants will be subjected to transabdominal and transperineal ultrasound at the beginning of active labor between 3 and 8 cm of cervical dilatation to evaluate the position of the fetal head and its descent At the delivery the position of the fetal head and the features of the second stage of the labor will be recorded
Detailed Description:
Background and rationale Occiput posterior position OP is the most common fetal malposition during labor Such anomaly shows a correlation with higher risk of operative delivery and cesarean section prolonged labor duration neonatal morbidity high-grade perineal lacerations It is estimated that around 15-30 of fetuses in cephalic presentation start the labor in OP Of these 10-15 remain OP at full cervical dilatation but only 5-8 remains in persistent OP position POPP at delivery especially in nulliparous women
The importance of knowing the precise position of the fetal head is related to the possible adverse outcome that POPP carries requiring adequate surveillance during labor and delivery The non-routinary surveillance consist of
Continuous non intermittent monitoring of fetal wellbeing with cardiotocography
Rationalization of peridural anesthesia doses due to prolonged labor
Maternal position during labor facilitating descent and rotation of the fetal head
Active cure of the perineum to reduce the risk of high-grade perineal tears
In case of operative delivery knowing the exact position of the fetal occiput ensure a better positioning of the vacuum extractor
Ultrasound in labor ward demonstrated a higher performance compared to routine care vaginal examination in diagnosing fetal occiput position Various approaches have been described to induce fetal head rotation manual or instrumental intrauterine attempts or maternal position changes without any strong evidence
The mechanism of POPP remains unclear Predisposing factors are several nulliparity android pelvis obesity fetal macrosomia preterm birth7 Some authors suggest that the presence of fibroids uterine adherences or analgesia in labor could affect the overall risk of malpositions Relatively to anesthesia some authors suggest that the prolonged second stage of labor could be the reason for a higher incidence of POPP in women undergoing peridural procedures Studies evaluating the rotation of the fetal head during labor progression reported discordant results Some authors suppose that POPP is secondary to an OP at the beginning of the labor others that anterior or transverse position can be modified by already mentioned risk factors
In a study conducted on a population of 918 women in labor reported how the main part of OP fetuses at the beginning of labor will rotate to OA at birth while cases of POPP are related to a persistence of posterior position rather than a malrotation Eggebo et al reported that the main part of women presenting POPP at birth showed different occiput position at the time of rupture of membranes reinforcing the theory of malrotation Another multicentric study on a population of 100 women reported no cases of POPP in fetuses with OA at the beginning of labor Furthermore evaluating the spine position the authors say that in case of OP and posterior spine one case out of seven rotates in OA at birth
Studies about prediction of POPP show heterogeneity small populations and in some cases exclusion of participants in case of cesarean section or operative deliveries Moreover the grade of descent of the fetal head is a fundamental information not always considered unlike cervical dilatation for diagnosis of active labor
OBJECTIVES
Primary Objective Primary objective of the study is to evaluate POPP in the study population
Secondary Objectives To develop a predictive model for diagnose POPP at the beginning of active labor
METHODS Study design Multicenter prospective cross-sectional interventional study without drug nor device Population We will enroll all pregnant women with diagnosis of active labor admitted to delivery room afferent to the to the participating centers satisfying the following inclusion criteria
Study duration The study will last 12 months Inclusion criteria
Age 18 yo
Pregnant women with diagnosis of active labor admitted to delivery room
Singleton
At term 37 weeks
Cephalic presentation
Signed written informed consent to study participation Exclusion criteria
Age 18 yo
Preterm deliveries
Multiple pregnancies
Elective cesarean section
Non-cephalic presentation
Incomplete obstetrical data
Refusal to provide informed consent
Variables and procedures For each participant several anamnestic data will be recorded at the enrollment Each participant after written consent once in active labor defined as cervical dilatation between 4 and 8 cm with presence of regular and painful uterine contractions will undergo transabdominal and transperineal ultrasound by expert sonographers Data about fetal occiput position fetal eyes visualization and fetal head descent measured by Angle of Progression will be recorded Then at the delivery we will evaluate the position of the fetal head at birth and the features of the second stage of the labor All neonatal clinical characteristics will be collected
At the enrollment after consent the following data will be recorded
Demographic and anthropometric data ie age y ethnicity height m weight kg BMI
Parity
Gestational Age weeks days
Cervical dilatation cm
Type of labor spontaneous induced
Membrane integrity
Then all the participants will undergo a transabdominal and transperineal US in lithotomic position to evaluate
Fetal occiput position anterior transverse posterior Fig1
In case of posterior occiput women will be divided in two groups according to the number of visible eyes one-eye vs two-eyes Fig 2
Fetal spine position anterior transverse posterior
Angle of progression AoP described as the angle between the long axis of the pubic bone and a line from the lowest edge of the pubis drawn tangential to the deepest bony part of the fetal skull
After the birth following data will be collected
Type of birth spontaneous operative vaginal cesarean sections CS
Position at birth
Eventual anesthesia
Kristeller manouver
Episiotomy or perineal tears
Active phase duration min and Second stage duration min
Sex and weight of the baby
APGAR score at 1 and 5 minutes
Cord blood samples pH and Base Excess arteriosus and venous
Eventual NICU admission
The importance of knowing the precise position of the fetal head is related to the possible adverse outcome that POPP carries requiring adequate surveillance during labor and delivery The non-routinary surveillance consist of
Continuous non intermittent monitoring of fetal wellbeing with cardiotocography
Rationalization of peridural anesthesia doses due to prolonged labor
Maternal position during labor facilitating descent and rotation of the fetal head
Active cure of the perineum to reduce the risk of high-grade perineal tears
In case of operative delivery knowing the exact position of the fetal occiput ensure a better positioning of the vacuum extractor
Ultrasound in labor ward demonstrated a higher performance compared to routine care vaginal examination in diagnosing fetal occiput position Various approaches have been described to induce fetal head rotation manual or instrumental intrauterine attempts or maternal position changes without any strong evidence
The mechanism of POPP remains unclear Predisposing factors are several nulliparity android pelvis obesity fetal macrosomia preterm birth7 Some authors suggest that the presence of fibroids uterine adherences or analgesia in labor could affect the overall risk of malpositions Relatively to anesthesia some authors suggest that the prolonged second stage of labor could be the reason for a higher incidence of POPP in women undergoing peridural procedures Studies evaluating the rotation of the fetal head during labor progression reported discordant results Some authors suppose that POPP is secondary to an OP at the beginning of the labor others that anterior or transverse position can be modified by already mentioned risk factors
In a study conducted on a population of 918 women in labor reported how the main part of OP fetuses at the beginning of labor will rotate to OA at birth while cases of POPP are related to a persistence of posterior position rather than a malrotation Eggebo et al reported that the main part of women presenting POPP at birth showed different occiput position at the time of rupture of membranes reinforcing the theory of malrotation Another multicentric study on a population of 100 women reported no cases of POPP in fetuses with OA at the beginning of labor Furthermore evaluating the spine position the authors say that in case of OP and posterior spine one case out of seven rotates in OA at birth
Studies about prediction of POPP show heterogeneity small populations and in some cases exclusion of participants in case of cesarean section or operative deliveries Moreover the grade of descent of the fetal head is a fundamental information not always considered unlike cervical dilatation for diagnosis of active labor
OBJECTIVES
Primary Objective Primary objective of the study is to evaluate POPP in the study population
Secondary Objectives To develop a predictive model for diagnose POPP at the beginning of active labor
METHODS Study design Multicenter prospective cross-sectional interventional study without drug nor device Population We will enroll all pregnant women with diagnosis of active labor admitted to delivery room afferent to the to the participating centers satisfying the following inclusion criteria
Study duration The study will last 12 months Inclusion criteria
Age 18 yo
Pregnant women with diagnosis of active labor admitted to delivery room
Singleton
At term 37 weeks
Cephalic presentation
Signed written informed consent to study participation Exclusion criteria
Age 18 yo
Preterm deliveries
Multiple pregnancies
Elective cesarean section
Non-cephalic presentation
Incomplete obstetrical data
Refusal to provide informed consent
Variables and procedures For each participant several anamnestic data will be recorded at the enrollment Each participant after written consent once in active labor defined as cervical dilatation between 4 and 8 cm with presence of regular and painful uterine contractions will undergo transabdominal and transperineal ultrasound by expert sonographers Data about fetal occiput position fetal eyes visualization and fetal head descent measured by Angle of Progression will be recorded Then at the delivery we will evaluate the position of the fetal head at birth and the features of the second stage of the labor All neonatal clinical characteristics will be collected
At the enrollment after consent the following data will be recorded
Demographic and anthropometric data ie age y ethnicity height m weight kg BMI
Parity
Gestational Age weeks days
Cervical dilatation cm
Type of labor spontaneous induced
Membrane integrity
Then all the participants will undergo a transabdominal and transperineal US in lithotomic position to evaluate
Fetal occiput position anterior transverse posterior Fig1
In case of posterior occiput women will be divided in two groups according to the number of visible eyes one-eye vs two-eyes Fig 2
Fetal spine position anterior transverse posterior
Angle of progression AoP described as the angle between the long axis of the pubic bone and a line from the lowest edge of the pubis drawn tangential to the deepest bony part of the fetal skull
After the birth following data will be collected
Type of birth spontaneous operative vaginal cesarean sections CS
Position at birth
Eventual anesthesia
Kristeller manouver
Episiotomy or perineal tears
Active phase duration min and Second stage duration min
Sex and weight of the baby
APGAR score at 1 and 5 minutes
Cord blood samples pH and Base Excess arteriosus and venous
Eventual NICU admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None