Labor Complication(POPP-UP)NCT05910359
Ultrasound Prediction of POPP in Active Labor
A study testing Ultrasound in people with Labor Complication and Fetal Head to Enter Pelvic Brim; Failure, Affecting Fetus or Newborn, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Persistent occiput posterior position (POPP) represents a relevant risk factor for various adverse outcomes: prolonged labor, higher incidence of operative delivery and/or cesarean section for non-reassuring fetal conditions, higher incidence of high-grade perineal tears (OASIS). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication, Fetal Head to Enter Pelvic Brim; Failure, Affecting Fetus or Newborn
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 593 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age ≥18 y.o.;
- 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.
Who cannot join
- • Age <18 y.o.;
- Preterm deliveries;
- Multiple pregnancies;
- Elective cesarean section;
- Non-cephalic presentation;
- Incomplete obstetrical data;
- Refusal to provide informed consent.
About this study
Official title: Ultrasound Prediction of Persistent Occiput Posterior Position in Active Labor: a Multicentric Prospective Cross-sectional Study
Persistent occiput posterior position (POPP) represents a relevant risk factor for various adverse outcomes: prolonged labor, higher incidence of operative delivery and/or 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.
Read the 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 y.o.;
- 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 y.o.;
- 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 (i.e., 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) (Fig.1)
- 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.
- Being tested
- Ultrasound
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
transabdominal and transperineal ultrasound by expert sonographers
| Study group | Role | What they receive |
|---|---|---|
| Persistent Occiput Posterior Position | Experimental | transabdominal and transperineal ultrasound by expert sonographers Receives: Diagnostic Test: Ultrasound |
| Anterior Occiput Position at delivery | Active comparator | transabdominal and transperineal ultrasound by expert sonographers Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of POPP in the study population
How many POPP in labor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective cross-sectional interventional study without drug nor device
- Masking
- None (open label)
- Enrolment
- 593 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Familiari Alessandra, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910359
- Sponsor's protocol ID
- 5830
- Acronym
- (POPP-UP)
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Prediction of Persistent Occiput Posterior Position in Active Labor: a Multicentric Prospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05910359
- Acronym / sponsor ID
- (POPP-UP) / 5830
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 593 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent occiput posterior position (POPP) represents a relevant risk factor for various adverse outcomes: prolonged labor, higher incidence of operative delivery and/or 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.
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 y.o.;
- 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 y.o.;
- 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 (i.e., 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) (Fig.1)
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter prospective cross-sectional interventional study without drug nor device
| Arm | Type | Receives |
|---|---|---|
| Persistent Occiput Posterior Position | Experimental | Diagnostic Test: Ultrasoundtransabdominal and transperineal ultrasound by expert sonographers |
| Anterior Occiput Position at delivery | Active comparator | Diagnostic Test: Ultrasoundtransabdominal and transperineal ultrasound by expert sonographers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age ≥18 y.o.;
Key exclusion criteria (7 listed)
- • Age <18 y.o.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasoundtransabdominal and transperineal ultrasound by expert sonographers | Diagnostic test | Anterior Occiput Position at delivery, Persistent Occiput Posterior Position |
Primary outcome
the incidence of POPP in the study population
Time frame: 1 year
How many POPP in labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Labor Complication and Fetal Head to Enter Pelvic Brim; Failure, Affecting Fetus or Newborn, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of POPP in the study population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.