Study Results
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Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2021-01-01
2022-05-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Intrapartum ultrasound
Intrapartum ultrasound will be performed by suprapubic and transperineal approach for 30 seconds.
Interventions
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Intrapartum ultrasound
Intrapartum ultrasound will be performed by suprapubic and transperineal approach for 30 seconds.
Eligibility Criteria
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Inclusion Criteria
* 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
* Multiple pregnancies
* Cases with fetal anomalies
* Intrauterine ex fetus cases
* Patients with vaginismus
18 Years
45 Years
FEMALE
Yes
Sponsors
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
OTHER
Responsible Party
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Arzu Bilge Tekin
Principal Investigator
Principal Investigators
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Murat Yassa, MD
Role: PRINCIPAL_INVESTIGATOR
Specialist
Niyazi Tug, MD
Role: STUDY_DIRECTOR
Chief of the department
Locations
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Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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LAIPUSG
Identifier Type: -
Identifier Source: org_study_id
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