- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04813237
Clinical Implications of Fetal Positioning During Delivery
29. april 2021 opdateret af: Barbara Baranowska, Żelazna Medical Centre, LLC
The project aims to find a relationship between the positioning of the foetus before and during birth and the results of obstetrics and to determine their incidence in the Polish population.
The study will be conducted by combining the use of ultrasound diagnostics, midwives observations during childbirth, analysis of medical documentation and a questionnaire on the activity of examined women.
The obtained results will be used to prepare guidelines for the birth in a particular foetus position.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the examination is to describe the difficulties associated with delivery in a non-optimal position of the fetus.
Initial observations show that such childbirth is perceived as difficult by both the women giving birth and the staff.
The aim of the study is to describe the level of difficulty of this labor, expressed as the experience of the woman, as well as all the elements that may affect the difficulty of this labor, for example, slower or no progress in labor, disturbances in systolic function, injuries, the need to use epidural anesthesia, increased blood loss.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Magdalena Witkiewicz, BA
- Telefonnummer: 603 404 799
- E-mail: magdawitkiewicz@o2.pl
Studiesteder
-
-
Mazowieckie
-
Warsaw, Mazowieckie, Polen, 01-004
- Rekruttering
- Żelazna Medical Centre, LLC
-
Kontakt:
- Baranowska Baranowska, PhD
- Telefonnummer: 509083263
- E-mail: bbaranowska@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
women coming to the 3rd level hospital with a birth house.
During a physiological pregnancy, with no severe coexisting diseases.
Beskrivelse
Inclusion Criteria:
- during childbirth,
- in a single pregnancy,
Exclusion Criteria:
- pelvic position of the fetus
- in whom labor is induced for reasons other than post-term pregnancy,
- women who came to the hospital in the second stage of labor
- severe diseases mother or foetus.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mode of delivery
Tidsramme: immediately after delivery
|
Mode of delivery as measured by number of women who had a vaginal, instrumental or operational delivery.
|
immediately after delivery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of delivery
Tidsramme: immediately after birth
|
the time of 1,2,3 and 4 stage of labor
|
immediately after birth
|
|
Uterine contractions
Tidsramme: during birth
|
uterine contractions as measured by number of contractions and assessment of uterine contractile coordination
|
during birth
|
|
Labor progress
Tidsramme: during birth
|
Labor progress as measured by assessment of the head insertion, advancement in the birth canal,
|
during birth
|
|
Epidural
Tidsramme: immediately after delivery
|
as measured by epidural or not
|
immediately after delivery
|
|
Perineum injury
Tidsramme: immediately after delivery
|
as measured by number and extent of injury
|
immediately after delivery
|
|
Episiotomy
Tidsramme: immediately after delivery
|
as measured by episiotomy or not
|
immediately after delivery
|
|
Methods of placental separation
Tidsramme: immediately after delivery
|
as measured by number of Duncan or SchultZ methods
|
immediately after delivery
|
|
Blood loss
Tidsramme: immediately after delivery
|
postpartum blood loss (ml)
|
immediately after delivery
|
|
Difficulty of childbirth
Tidsramme: immediately after delivery
|
difficulty of childbirth as measured by subjective assessment of the woman and the midwife
|
immediately after delivery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Baranowska Baranowska, PhD, Żelazna Medical Centre, LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ahmad A, Webb SS, Early B, Sitch A, Khan K, Macarthur C. Association between fetal position at onset of labor and mode of delivery: a prospective cohort study. Ultrasound Obstet Gynecol. 2014 Feb;43(2):176-82. doi: 10.1002/uog.13189.
- Matsuo K, Shimoya K, Ushioda N, Kimura T. Maternal positioning and fetal positioning in utero. J Obstet Gynaecol Res. 2007 Jun;33(3):279-82. doi: 10.1111/j.1447-0756.2007.00524.x.
- Guittier MJ, Othenin-Girard V, de Gasquet B, Irion O, Boulvain M. Maternal positioning to correct occiput posterior fetal position during the first stage of labour: a randomised controlled trial. BJOG. 2016 Dec;123(13):2199-2207. doi: 10.1111/1471-0528.13855. Epub 2016 Jan 24.
- Choi SK, Park YG, Lee da H, Ko HS, Park IY, Shin JC. Sonographic assessment of fetal occiput position during labor for the prediction of labor dystocia and perinatal outcomes. J Matern Fetal Neonatal Med. 2016 Dec;29(24):3988-92. doi: 10.3109/14767058.2016.1152250. Epub 2016 Mar 7.
- Khan KS. Optimal fetal positioning: a theory in tatters-time to rewrite textbooks. BJOG. 2016 Dec;123(13):2207. doi: 10.1111/1471-0528.13872. Epub 2016 Jan 25. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
31. marts 2021
Primær færdiggørelse (Forventet)
30. juni 2021
Studieafslutning (Forventet)
30. december 2021
Datoer for studieregistrering
Først indsendt
12. marts 2021
Først indsendt, der opfyldte QC-kriterier
19. marts 2021
Først opslået (Faktiske)
24. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PN/29/2020
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