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

NCT ID: NCT04075630

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2024-01-09

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).

Detailed Description

Artificial labour induction is a medical intervention used in the interest of the mother or unborn child, aimed at provoking birth by inducing uterine contractions artificially, leading to cervical effacement and dilation. The purpose is to end the pregnancy in the interest of the mother and/or foetus.

According to the latest results of the Perinatal Enquiry (2016), induced labour rates total around 22% of pregnancies (767.000 births in 2017) in all maternity clinics. For the university hospitals of Nimes and Montpellier, with Level 3 maternity units (thus requiring a higher rate of inductions), this represents 515 and 550 pregnancies respectively (2017 figures).

There are several methods of inducing labour: use of a cervical ripening balloon (a medical device with which the onset of labour is provoked mechanically), vaginal inserts containing prostaglandins or intravenous perfusion with oxytocin combined with water-breakage. These labour-induction methods may be used alone or in succession depending on the evaluation of the cervix using the Bishop score as a reference. Each method has its own benefits and risks.

There is variability between establishments in the protocols used for cervical ripening.

The Nimes and Montpellier centres both use the same methods, but with different sequences.

Studies are mainly devoted to evaluating each method individually in terms childbirth by vaginal delivery and duration of labour.

Maternal satisfaction, which is a rarely studied multifactorial evaluation, is correlated with women's psychological outcome. A bad experience during childbirth appears to increase the risk of post-partum (PP) psychological disorders.

Considering the current literature available, although there have been trials comparing two isolated labour-induction methods, like the study by Probaat (Jozwiak et al., 2013), which compared obstetrical and neonatal outcomes with the cervical ripening balloon and the prostaglandin insert, none of these studies investigated their impact on maternal satisfaction. Although there have been a few studies evaluating maternal satisfaction at childbirth, there have not been any evaluating satisfaction during artificial labour-induction in a pragmatic situation.

The aim of our study was therefore to evaluate the impact on semi-immediate maternal satisfaction under pragmatic, real-life conditions depending on the various possible induction scenarios (both in terms of the number of methods used, from 1 to 3, and the possible combinations when at least 2 or more methods were used ).

Conditions

Labor Induction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• 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.

Exclusion Criteria

The person is in a period of exclusion determined by a previous study.

• The person has been placed under judicial protection and is under guardianship or curatorship.
• It is impossible to give the person accurate information.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

vincent letouzey, M.

Role: PRINCIPAL_INVESTIGATOR

CHU de Nîmes Service de Gynécologie Obstétrique

Locations

Centre Hospitalier Universitaire

Nîmes, Gard, France

CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique

Montpellier, Hérault, France

Countries

France

Other Identifiers

NIMAO/2018-03/BC-01

Identifier Type: -

Identifier Source: org_study_id