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Patient Satisfaction With Mechanical Cervical Ripening

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04683081
Enrollment
34
Registered
2020-12-24
Start date
2020-03-01
Completion date
2021-05-20
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satisfaction, Patient

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

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.

Interventions

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction levelwithin the first 24 hours after birthOverall patient satisfaction score is obteined by VAS score system and Salmon's items list
Pain scoresimmediately after applicationPain scores are obteined by VAS score system

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026