Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

NCT04075630 | Completed

• 1 other identifier: NIMAO/2018-03/BC-01
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

Our hypothesis is that there is one sequence of labour-induction that leads to a better experience of childbirth than others. This is based on the following underlying theories :

• Maternal satisfaction depends on the number of labour-inducing sequences
• A longer labour-induction would be experienced less positively than a shorter one
• The experience is correlated with maternal outcomes ( vaginal / Caesarian delivery, spontaneous birth or instrument-assisted birth, maternal complications ) and neonatal outcomes (neonatal complications, secondary hospitalization).

Conditions

Labor Induction

Keywords

childbirth; oxytocin; prostaglandin; cervical ripening balloon

Outcome Measures

Primary Outcomes (1)

• Overall patient satisfaction

  Overall patient satisfaction evaluated via a 4-point Likert scale (1= not satisfied, 2 = moderately satisfied, 3 = satisfied, 4 = very satisfied) on a touchscreen.

  2 hours after giving birth

Secondary Outcomes (41)

• Patient satisfaction evaluated via the W-DEQ questionnaire

  2 hours after giving birth

• Post-partum QEVA satisfaction questionnaire

  1-2 months after giving birth

• Different methods of labour-induction used

  6 months after giving birth

• Spontaneous vaginal deliveries

  48 hours maximum

• Rate of instrument-assisted vaginal deliveries

  48 hours maximum

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women at the end of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women 18+ admitted to gynecology-obstetric depts. of Montpellier \& Nîmes University Hospitals for artificial labor-induced childbirth. Sociodemographic and medical variables will be noted: patient's knowledge of labor-induction, labor in childbirth, age, weight, height (BMI), no. of previous pregnancies, childbirths, miscarriages, abortions, medically-motivated induced terminations, medical antecedents (comorbidities), important surgery (esp. uterine), ongoing treatment, tobacco/alcohol/cannabis intake, Down's syndrome screening, pregnancy particularities (medically-assisted procreation), antenatal diagnosis, no. of hospital consultations, gestational age at admission, information received, other newborn data (term, weight, size, cranial perimeter at birth), reason for induction.

You may qualify if:

• The patient has made no formal opposition to taking part in the study.
• The patient must be affiliated to/have the benefit of a health insurance scheme.
• The patient is at least 18 years old.
• The patient is capable of understanding the instructions required for answering questionnaires in French.
• Concerning the targeted population:
• The patient has a medical indication for labour-induction.
• Term ≥ 37 weeks.
• The foetus is alive and viable, without any known lethal pathology

You may not qualify if:

• The person has been placed under judicial protection and is under guardianship or curatorship.
• It is impossible to give the person accurate information.
• The patient does not have the possibility to answer the questionnaire at 1 month
• Contra-indication for labour-induction or vaginal delivery
• Foetal presentation other than cephalic.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Centre Hospitalier Universitaire

Nîmes, Gard, 30029, France

Location

CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique

Montpellier, Hérault, 34090, France

Location

Study Officials

• vincent letouzey, M.

  CHU de Nîmes Service de Gynécologie Obstétrique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: October 2, 2019
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (2)