- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04683081
Patient Satisfaction With Mechanical Cervical Ripening
Cervical Ripening: a Comparison of Three Mechanical Methods in Term of Patient Satisfaction
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective observational study. The planned sample size is 34 pregnant women per group with 90% power and 0.05 alpha error.
VAS score systems and Salmon's item list were used to evaluate the satisfaction level.
The inclusion criteria are age between 18 and 40, singleton pregnancy, vertex presentation, bishop score <6, using a foley catheter cook balloon catheter or modified double-balloon Foley catheter for cervical ripening and high-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).
The exclusion criteria are being younger than 18 or over 40, communication problems, bishop score >6, being at active labor, multifetal pregnancy, non-vertex presentation, scarred uterus (cesarean or myomectomy), known fetal structural or chromosomal anomaly, presence of non-reassuring fetal cardiotocography before cervical ripening, regional anesthesia during the first stage, operative delivery, presence of maternal, fetal or neonatal complication.
The primary outcomes are the differences in satisfaction level between methods with using either the VAS score system or Salmon's item list and pain scores.
The secondary outcomes are the effects of giving birth within 24 hours, parity status, the length of the first stage of labor education level and cesarean section due to failed induction on the satisfaction level.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Kemal Sarsmaz, MD
- Telefonnummer: +905068074452
- E-post: drsarsmazkemal@gmail.com
Studer Kontakt Backup
- Navn: Aykan Yucel, Prof
- E-post: aykanyucel@gmail.com
Studiesteder
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Ankara, Tyrkia, 06000
- Rekruttering
- University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
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Ta kontakt med:
- Kemal Sarsmaz, MD
- Telefonnummer: +905068074452
- E-post: drsarsmazkemal@gmail.com
-
Ta kontakt med:
- Aykan Yucel, Prof
- E-post: aykanyucel@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age between 18 and 40
- Singleton pregnancy
- Vertex presentation
- Bishop score <6
- Using a Foley catheter cook balloon catheter or modified double-balloon Foley catheter for cervical ripening
- High-risk pregnancy (Oligohydramnios, polyhydramnios, intrauterine growth retardation, pregestational or gestational diabetes, hypertensive disorders).
Exclusion Criteria:
- Being younger than 18 or over 40
- Communication problems
- Bishop score >6
- Being at active labor
- Multifetal pregnancy
- Non-vertex presentation
- Scarred uterus (cesarean or myomectomy)
- Known fetal structural or chromosomal anomaly
- Presence of non-reassuring fetal cardiotocography before cervical ripening
- Regional anesthesia during the first stage
- Operative delivery
- Presence of maternal, fetal or neonatal complication.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Foley catheter group
pregnant women who were applied Foley catheter for cervical ripening
|
mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
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Cook balloon catheter group
pregnant women who were applied Cook balloon catheter for cervical ripening
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mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
|
Modified double-balloon Foley catheter group
pregnant women who were applied modified double-balloon Foley catheter for cervical ripening
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mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Patient satisfaction level
Tidsramme: within the first 24 hours after birth
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Overall patient satisfaction score is obteined by VAS score system and Salmon's items list
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within the first 24 hours after birth
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Pain scores
Tidsramme: immediately after application
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Pain scores are obteined by VAS score system
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immediately after application
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial. Singapore Med J. 2018 Aug;59(8):419-424. doi: 10.11622/smedj.2018097.
- Akca A, Corbacioglu Esmer A, Ozyurek ES, Aydin A, Korkmaz N, Gorgen H, Akbayir O. The influence of the systematic birth preparation program on childbirth satisfaction. Arch Gynecol Obstet. 2017 May;295(5):1127-1133. doi: 10.1007/s00404-017-4345-5. Epub 2017 Mar 16.
- Tomlinson AJ, Archer PA, Hobson S. Induction of labour: a comparison of two methods with particular concern to patient acceptability. J Obstet Gynaecol. 2001 May;21(3):239-41. doi: 10.1080/01443610120046314.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- patient satisfaction
Legemiddel- og utstyrsinformasjon, studiedokumenter
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