Clinical trial NCT04796155: Intrapartum Ultrasonography in Labour Arrest
Official title: The Use of Intrapartum Ultrasonography in the Evaluation of Labour Arrest in the First and Second Stage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Pelvic Floor
Delivery Complication
Maternal-Fetal Relations
Keywords: intrapartum ultrasound
labour arrest
fetal head position
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women whose active labour progress is prolonged

Brief summary: Determination of fetal head position during labour is highly subjective and depends on clinician's experience in vaginal digital examination. Monitoring the progress of labour with intrapartum ultrasound (IU) exhibits higher accuracy rates. However, the dynamic process of labour needs very frequent sonographic examination and that may decrease the feasibility. Consultation to IU at certain time points can positively limit the need for ultrasound, increase the effectiveness of IU and allow for safer labour in consistency with traditional labour management. This study aims to investigate the use of IU in cases with suspected and diagnosed labour arrest in both the first and second stage of labour.

Detailed description: Low-risk pregnant women with singleton, vertex fetus who are at their 36th gestational weeks and above with suspected first and second stages of labour arrest will be enrolled in this study. Intrapartum ultrasound with transperineal and transabdominal approach will be performed at two specific time points; 1) Suspicion of labour arrest, 2) Diagnosis of labour arrest. The fetal head position, station, direction, progression and the structure of pubic arch will be evaluated with IU.

All ultrasound examinations will be monitored and recorded to the memory storage of ultrasound device. Recorded ultrasound examinations will be reviewed and measurements will be performed at the end of the study period by two experienced clinicians who are not involved in the examinations. These two blinded clinicians are not aware of labor outcomes, delivery types, maternal and neonatal outcomes.

General terms are defined according to the NICE guidelines. Those are; the first stage of labour is established when there are regular painful contractions and there is progressive cervical dilatation from 4 cm. If delay in the established first stage is suspected, all aspects of progress in labour are assessed when diagnosing delay, including; cervical dilatation of less than 2 cm in 4 hours for first labours, cervical dilatation of less than 2 cm in 4 hours, or a slowing in the progress of labour for second or subsequent labours, descent, and rotation of the baby's head, changes in the strength, duration and frequency of uterine contractions. Amniotomy is offered to a woman with suspected delay in the established first stage of labour and women are advised to have a vaginal examination 2 hours later, and diagnose delay if progress is less than 1 cm. If oxytocin is used due to insufficient uterine contractions delay is diagnosed as progress is less than 2 cm within 4 hours. With regard to the second stage of labour, for a nulliparous woman; birth would be expected to take place within 3 hours of the start of the active second stage in most women. The delay is diagnosed in the active second stage when it has lasted 2 hours and suspected delay if progress (in terms of rotation and/or descent of the presenting part) is inadequate after 1 hour of the active second stage. For a multiparous woman: birth would be expected to take place within 2 hours of the start of the active second stage in most women. The delay in the active second stage is diagnosed when it has lasted 1 hour for multiparous women and suspected delay if progress (in terms of rotation and/or descent of the presenting part) is inadequate after 30 minutes of the active second stage.

The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) practical guidelines on intrapartum ultrasound recommend the evaluation of head position and descent during the active phase of labour when labor progress is slow and when operative delivery is considered. The use of IU is not meant to change the classic algorithm of labour monitoring but to provide objective and reliable evaluations of the traditional parameters of crucial importance when prolonged or arrested labour is suspected.

The aim of this study is to evaluate the use of IU in prolonged labour with optimizing the timing of IU.

Eligibility criteria: Inclusion Criteria:

* Low-risk pregnant women at their 36th gestational weeks and above
* Singleton, vertex fetus births
* Patients in their active phase of labour in either the first or second phase of labour
* Cases with labour arrest suspicion

Exclusion Criteria:

* Breech presentation
* Multiple pregnancies
* Cases with fetal anomalies
* Intrauterine ex fetus cases
* Patients with vaginismus

Primary outcomes:
measure: Mode of delivery
timeFrame: At the end of delivery
Secondary outcomes:
measure: fetal head station
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
measure: angle of progression
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
measure: head progression distance
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
measure: head direction
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
measure: rotation angle
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
measure: occiputospine angle
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
measure: subpubic arch angle
timeFrame: This outcome will be measured twice: (1) During labour after 4 hours of progress if cervical change is 2cm or below. (2) During labour after 2 hours of amniotomy if cervical change is 1cm or below.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
Study officials:
affiliation: Specialist
name: Murat Yassa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief of the department
name: Niyazi Tug, MD
role: STUDY_DIRECTOR
References:
citation: Blankenship SA, Raghuraman N, Delhi A, Woolfolk CL, Wang Y, Macones GA, Cahill AG. Association of abnormal first stage of labor duration and maternal and neonatal morbidity. Am J Obstet Gynecol. 2020 Sep;223(3):445.e1-445.e15. doi: 10.1016/j.ajog.2020.06.053.
citation: Pergialiotis V, Bellos I, Antsaklis A, Papapanagiotou A, Loutradis D, Daskalakis G. Maternal and neonatal outcomes following a prolonged second stage of labor: A meta-analysis of observational studies. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:62-69. doi: 10.1016/j.ejogrb.2020.06.018. Epub 2020 Jun 10.
citation: Ghi T, Eggebo T, Lees C, Kalache K, Rozenberg P, Youssef A, Salomon LJ, Tutschek B. ISUOG Practice Guidelines: intrapartum ultrasound. Ultrasound Obstet Gynecol. 2018 Jul;52(1):128-139. doi: 10.1002/uog.19072.
citation: Bellussi F, Ghi T, Youssef A, Salsi G, Giorgetta F, Parma D, Simonazzi G, Pilu G. The use of intrapartum ultrasound to diagnose malpositions and cephalic malpresentations. Am J Obstet Gynecol. 2017 Dec;217(6):633-641. doi: 10.1016/j.ajog.2017.07.025. Epub 2017 Jul 22.
citation: Dall'Asta A, Angeli L, Masturzo B, Volpe N, Schera GBL, Di Pasquo E, Girlando F, Attini R, Menato G, Frusca T, Ghi T. Prediction of spontaneous vaginal delivery in nulliparous women with a prolonged second stage of labor: the value of intrapartum ultrasound. Am J Obstet Gynecol. 2019 Dec;221(6):642.e1-642.e13. doi: 10.1016/j.ajog.2019.09.045. Epub 2019 Oct 4.