Intrapartum Ultrasonography in Labour Arrest

Ultrasonography Clinical Trial

— IPUSGLA  

Official title:

The Use of Intrapartum Ultrasonography in the Evaluation of Labour Arrest in the First and Second Stage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796155
• Other study ID #: LAIPUSG
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: June 2022
• Source: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 15, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery Complication
• Maternal-Fetal Relations
• Pelvic Floor
• Ultrasonography

Intervention

Diagnostic Test:
• Intrapartum ultrasound
Intrapartum ultrasound will be performed by suprapubic and transperineal approach for 30 seconds.

Locations

Country	Name	City	State
Turkey	Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. Review. — View 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. — View 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. — View Citation

Ghi T, Eggebø 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of delivery	To predict the mode of delivery; including spontaneous vaginal delivery, operative vaginal delivery, cesarean section	At the end of delivery
Secondary	fetal head station	Intrapartum fetal head station will be measured along the longest visible axis of the fetal head, between the intersections with the infrapubic line and the deepest bony part of the fetal head, subtracting 3 cm for the level of the ischial spines.	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.
Secondary	angle of progression	Angle of progression is defined as the angle existing between a line drawn between the superior and inferior apex of symphysis and a line running from the inferior apex tangentially to the fetal skull contour.	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.
Secondary	head progression distance	Head progression distance is defined as the longest vertical distance of the fetal cranium from the infrapubic line.	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.
Secondary	head direction	Head direction is defined as the measurement of the fetal head direction compared to the long axis of the pubic symphysis. Three types of head directions can be determined: ''Head up'', when the line perpendicular to the widest diameter of the head points ventrally at an angle 30, ''Head down'' when this angle is inferior than 0, and ''horizontal'' (all other angles).	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.
Secondary	rotation angle	Rotation angle will be measured in the transverse plane to identify the midline of the fetal head, defined as the echogenic line interposed between the two cerebral hemispheres. The angle formed by the midline and the anteroposterior diameter of the pubis will be assessed.	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.
Secondary	occiputospine angle	Occiputospine angle is defined as the degree of fetal head deflection and will be measured by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) in a sagittal plane with suprapubic approach.	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.
Secondary	subpubic arch angle	Subpubic arch angle will be measured between the inferior borders of the pubic rami that converge at the middle of the pubic symphysis.	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.

External Links

•   NICE guideline