Delivery Clinical Trial
— MATUCOL-QOLOfficial title:
Quality of Life 3 Months After Cervical Ripening
| NCT number | NCT04897451 |
| Other study ID # | CHD21-0028 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 8, 2021 |
| Est. completion date | December 12, 2021 |
| Verified date | December 2021 |
| Source | Centre Hospitalier Departemental Vendee |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | December 12, 2021 |
| Est. primary completion date | December 12, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Woman who experienced at least one method of cervical ripening in our hospital Exclusion Criteria: - Patient's refusal |
| Country | Name | City | State |
|---|---|---|---|
| France | CHD Vendée | La Roche Sur Yon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Departemental Vendee |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 3 months after delivery |
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