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

Labor Induction Clinical Trial

Official title: Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 ). ;

Related Conditions & MeSH terms

• Labor Induction

• NCT number: NCT04075630
• Study type: Observational
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: vincent letouzey, M.
• Phone: 0466686868
• Email: vincent.letouzey@chu-nimes.fr
• Status: Recruiting
• Start date: October 2, 2019
• Completion date: April 2024