Patient Satisfaction With Mechanical Cervical Ripening

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ClinicalTrials.gov Identifier: NCT04683081

Recruitment Status : Recruiting

First Posted : December 24, 2020

Last Update Posted : December 24, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

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

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
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

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Study Type :	Observational
Estimated 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 :	March 1, 2020
Estimated Primary Completion Date :	March 2021
Estimated Study Completion Date :	May 2021

Groups and Cohorts

Group/Cohort	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 :

Patient satisfaction level [ Time Frame: within the first 24 hours after birth ]
Overall patient satisfaction score is obteined by VAS score system and Salmon's items list
Pain scores [ Time Frame: immediately after application ]
Pain scores are obteined by VAS score system

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Pregnant women who were applied one of the mechanical cervical ripening methods, Foley catheter, Cook balloon catheter or modified double-balloon Foley catheter

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683081

Contacts

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Contact: Kemal sarsmaz, MD	+905068074452	drsarsmazkemal@gmail.com
Contact: Aykan Yucel, Prof		aykanyucel@gmail.com

Locations

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Turkey
University of Health Sciences, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital	Recruiting
Ankara, Turkey, 06000
Contact: Kemal Sarsmaz, MD +905068074452 drsarsmazkemal@gmail.com
Contact: Aykan Yucel, Prof aykanyucel@gmail.com

Sponsors and Collaborators

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

More Information

Publications:

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.

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.

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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:	December 24, 2020 Key Record Dates
Last Update Posted:	December 24, 2020
Last Verified:	December 2020

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

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