Intrapartum Ultrasonography in Labour Arrest

NCT04796155 | Completed

• 1 other identifier: LAIPUSG
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

intrapartum ultrasound; labour arrest; fetal head position

Outcome Measures

Primary Outcomes (1)

• Mode of delivery

  To predict the mode of delivery; including spontaneous vaginal delivery, operative vaginal delivery, cesarean section

  At the end of delivery

Secondary Outcomes (7)

• fetal head station

  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.

• angle of progression

  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.

• head progression distance

  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.

• head direction

  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.

• rotation angle

  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.

Study Arms (1)

labour arrest

Pregnant women whose labour progress is delayed and suspected or diagnosed as labour arrest according to the NICE guidelines. Intrapartum ultrasound will be performed at the suspicion of labour arrest in the active phase of the first and second stage of labour. Amniotomy will be performed as routine obstetric care according to the local clinical protocols in accordance with the NICE guideline. Later, diagnosis of labour arrest will be made in slow progress following amniotomy (\<1cm cervical dilatation in 2 hours) where a sonographic examination will be repeated.

Diagnostic Test: Intrapartum ultrasound

Interventions

Intrapartum ultrasound DIAGNOSTIC_TEST

Intrapartum ultrasound will be performed by suprapubic and transperineal approach for 30 seconds.

labour arrest

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women whose active labour progress is prolonged

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 32883453 BACKGROUND

• 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.

  PMID: 32570187 BACKGROUND

• 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.

  PMID: 29974596 BACKGROUND

• 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.

  PMID: 28743440 BACKGROUND

• 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.

  PMID: 31589867 BACKGROUND

Related Links

• NICE guideline

Study Officials

• Murat Yassa, MD

  Specialist

  PRINCIPAL INVESTIGATOR

• Niyazi Tug, MD

  Chief of the department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 12, 2021
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 15, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

TU (1)