Patient Satisfaction With Mechanical Cervical Ripening

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04683081
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Satisfaction, Patient	Device: mechanical cervical ripening

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 34 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cervical Ripening: a Comparison of Three Mechanical Methods in Term of Patient Satisfaction
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Foley catheter group pregnant women who were applied Foley catheter for cervical ripening	Device: mechanical cervical ripening; mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
Cook balloon catheter group pregnant women who were applied Cook balloon catheter for cervical ripening	Device: mechanical cervical ripening; 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	Device: mechanical cervical ripening; mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery

Outcome Measures

Primary Outcome Measures

1. Patient satisfaction level [within the first 24 hours after birth]

   Overall patient satisfaction score is obteined by VAS score system and Salmon's items list

2. Pain scores [immediately after application]

   Pain scores are obteined by VAS score system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital	Ankara		Turkey	06000

Sponsors and Collaborators

• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Kemal Sarsmaz, MD, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04683081
• Other Study ID Numbers: patient satisfaction
• First Posted: Dec 24, 2020
• Last Update Posted: Dec 24, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 24, 2020