Clinical trial NCT04862182: Intrapartum Ultrasound in Predicting Mode of Delivery
Official title: The Value of Intrapartum Ultrasound in Predicting Mode of Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasound Therapy; Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who present to the labour ward in the first stage of labour and willing to participate in the study.

Brief summary: Determine the value of intrapartum scan measurement(s) in predicting the mode of delivery.

Detailed description: The assessment and management of progress of labour is based on subjective clinical findings. The diagnosis of delay in labour and decisions regarding the timing and / or type of intervention(s) rely on clinical abdominal examination and digital vaginal assessment of the degree of cervical dilatation, the position of the presenting part of the baby and its station in relation to the maternal pelvis . Several studies have demonstrated the inaccuracy and the lack of consistency in such assessment between different practitioners especially in certain malpositions, malpresentations or with excessive subcutaneous tissue oedema .

One of the important clinical parameters that is assessed in labour is the position of the fetal head. Precise knowledge of fetal occiput position in labour is essential because some malpositions, like a persistent occiput posterior position is associated with higher risk of operative delivery and maternal and perinatal morbidity. The correct determination of head position is crucial before attempting any operative vaginal delivery. Moreover, knowing the exact presentation is also of paramount importance. For example, the differentiation between a face and a brow presentation is important in clinical management particularly that the engaging diameters of the latter presentation are too big in a term baby for a safe vaginal birth to occur, Sonographic assessment of fetal head position is best performed by transabdominal imaging in axial and sagittal planes .

Another parameter that is important in evaluating the progress of labour is the fetal head station. The fetal head station is the level of the fetal head in the birth canal relative to the plane of the maternal ischial spines. Serial clinical assessments by digital vaginal examination give an indication of the progress in head decent throughout the labour process, Sonographic assessment of fetal head station is best performed by transperineal ultrasound in the midsagittal or axial plane .

Several authors reported that ultrasound examination is more accurate and reproducible than clinical examination in the diagnosis of fetal head position and station and in the prediction of arrest of labor . It has also been suggested that ultrasound examination has the potential to stratify women who have a spontaneous vaginal delivery from those who end up having an operative birth Furthermore, it has been demonstrated that it is feasible to rely on ultrasound to predict the outcome of a planned operative vaginal birth .

However, currently, there is no consensus regarding the best timing of intrapartum scanning, at least for some of these measurements. Similar there is no general agreement regarding which measurements should be obtained and how useful if some of these measurements are integrated into a prediction model together with demographic or other clinical parameters.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* Full Term pregnancy
* Vertex presentation
* Singleton pregnancy
* In labour

Exclusion Criteria:

* Multiparous women
* Preterm labour
* Non vertex presentation
* Multi-fetal pregnancy
* Planned for elective Cesarean Section
* Underlying medical diseases
* Those unwilling to participate in the study

Primary outcomes:
measure: The rate of intrapartum Cesarean Section
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Barak O, Levy R, Flidel O, Zaks S, Gillor M, Hagay Z, Vaisbuch E. The Routine Use of Intrapartum Ultrasound in Clinical Decision-Making during the Second Stage of Labor - Does It Have Any Impact on Delivery Outcomes? Gynecol Obstet Invest. 2018;83(1):9-14. doi: 10.1159/000455847. Epub 2017 Feb 22.
citation: Brunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31.
citation: Sherer DM, Abulafia O. Intrapartum assessment of fetal head engagement: comparison between transvaginal digital and transabdominal ultrasound determinations. Ultrasound Obstet Gynecol. 2003 May;21(5):430-6. doi: 10.1002/uog.102.
citation: Lipschuetz M, Cohen SM, Lewkowicz AA, Amsalem H, Haj Yahya R, Levitt L, Yagel S. [PROLONGED SECOND STAGE OF LABOR: CAUSES AND OUTCOMES]. Harefuah. 2018 Nov;157(11):685-690. Hebrew.