CClinicalTrials.gg
CompletedNCT04897451MATUCOL-QOLUpdated Sep 28, 2022

Quality of Life After Cervical Ripening

An observational study in Delivery, sponsored by Centre Hospitalier Departemental Vendee. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by Centre Hospitalier Departemental Vendee · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
Female
01

Study summary

Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor.

A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction.

However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening.

The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.

02

Conditions studied

  • Delivery
03

In context

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All Women who experienced at least one method of cervical ripening in our hospital.

Inclusion criteria

  • Woman who experienced at least one method of cervical ripening in our hospital

Exclusion criteria

Exclusion Criteria:

  • Patient's refusal
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Women with cervical ripening in the context of artificial labor induction

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    EQ5D-5L questionnaire self-reported 3 months after delivery

06

What researchers measure

Primary outcomes

  1. EuroQol 5 Dimension Score

    Quality of life from the EuroQol 5 Dimension questionnaire For each of the dimensions, there are 5 levels coded from 1 to 5. A one-digit number is obtained for each dimension. By combining the 5 dimensions, a 5-digit number is obtained, ranging from 11111 to 55555, representing the health status of the respondent. The code 11111 indicates a person with no problems on the 5 dimensions.

    Time frame: 3 months after delivery

07

Study locations

1 site
  • CHD Vendée
    La Roche Sur Yon, 85000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04897451
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
May 21, 2021
Start date
Jul 8, 2021
Primary completion
Dec 12, 2021
Completion
Dec 12, 2021
Last update
Sep 28, 2022

Study contacts

Guillaume DUCARME
principal investigator · CHD Vendee

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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