Patient Satisfaction With Mechanical Cervical Ripening

Satisfaction, Patient Clinical Trial

Official title:

Cervical Ripening: a Comparison of Three Mechanical Methods in Term of Patient Satisfaction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683081
• Other study ID #: patient satisfaction
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: May 2021

Study information

• Verified date: December 2020
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Contact: Kemal sarsmaz, MD
• Phone: +905068074452
• Email: drsarsmazkemal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, we aimed to compare three mechanical methods such as foley catheter, cook balloon catheter and modified double-balloon Foley catheter for cervical ripening in terms of patient satisfaction

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Satisfaction, Patient

Intervention

Device:
• mechanical cervical ripening
mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction level	Overall patient satisfaction score is obteined by VAS score system and Salmon's items list	within the first 24 hours after birth
Primary	Pain scores	Pain scores are obteined by VAS score system	immediately after application