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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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 groups in NCT05910359
Study groupRoleWhat they receive
Persistent Occiput Posterior PositionExperimentaltransabdominal and transperineal ultrasound by expert sonographers
Receives: Diagnostic Test: Ultrasound
Anterior Occiput Position at deliveryActive comparatortransabdominal 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.

  1. 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.

  1. First posted18 Jun 2023
  2. Study start15 Jun 2023 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion15 Jun 2024 (estimated)

Resources

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)
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

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.

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