The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

The ophthalmic artery Doppler has been recently proposed as a potential "soft marker" for placental insufficiency in retrospective and observational studies, with similar clinical significance with respect to Uterine Artery (UA) Doppler evaluation and it is currently being investigated as an adjunctive clinical instrument to predict pre-eclampsia (PE) occurrence. Placental insufficiency strictly correlates with intrapartum fetal adverse outcomes and a concomitant induction of labor, alone, may further increase the hypoxic stress on the fetus during labor. This can be reflected by cardiotocographic alterations during labor, ultimately leading to emergency cesarean deliveries or instrumental vaginal deliveries.

Despite great advancements in understanding various maternal-fetal pathologies, the investigators are still not able to properly detect fetuses that are at higher risk for intrapartum compromise among those receiving an induction of labor. Therefore, the aim of this prospective study is to investigate any potential association between altered ophthalmic artery Doppler PSV ratio measured before labor induction in at-term, pregnant patients with intra-partum fetal compromise. Furthermore, the investigators aim to also measure an additional parameter that is the optic nerve sheath diameter (ONSD) - an indirect measure of intracranial pressure - before and after the second stage of labour, with the aim of studying its physiology during and after delivery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Pregnant patients after 37 weeks of gestation undergoing induction of labor

Ability to provide written informed consent

Disqualifiers

Age <18 years

Known fetal malformations

Known fetal genetic syndromes

Multiple pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Ophthalmic Artery Doppler

    Diagnostic test

    Right before labour induction, once the patient is already admitted into the inpatient ward - as an elective admission for scheduled labour induction - we will perform an ultrasound by gently applying the probe onto the eyelid of the patient, using sterile gel. We will then measure both the Doppler velocity of the Ophthalmic Artery as well as the Optic Nerve Sheath Diameter (ONSD). The ONSD will then be measured again right after delivery following the exact same procedure.

Treatment groups

1,477 Participants
are divided into 1 treatment group
Group A: Ophthalmic Artery Doppler AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of in-labor cesarean delivery due to fetal hypoxic stress, assessed in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.

Occurrence of cesarean delivery during labor due to fetal hypoxic stress, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.

Time frame
From start of labor induction until delivery, up to 72 hours.

Secondary outcomes

1

instrumental vaginal delivery for fetal hypoxic stress

Occurrence of instrumental vaginal delivery due to fetal hypoxic stress, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.

Time frame
From start of labor induction until delivery, up to 72 hours.
2

Cesarean delivery for any indication

Occurrence of cesarean delivery for any indication, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.

Time frame
From start of labor induction until delivery, up to 72 hours.
3

Cesarean delivery for clinical or subclinical chorioamnionitis

Occurrence of cesarean delivery due to clinical or subclinical chorioamnionitis, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.

Time frame
From start of labor induction until delivery, up to 72 hours.
4

Umbilical arterial pH <7.0

Occurrence of umbilical arterial cord blood pH \<7.0 at delivery, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.

Time frame
At delivery

Other outcomes

1

Change in Optic Nerve Sheath Diameter (ONSD)

Change in maternal optic nerve sheath diameter measured before labor induction and after delivery.

Time frame
Before labor induction and up to 30 minutes after delivery

Locations

This trial has no locations.

Sponsors and contacts

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