Clinical trial NCT04075630: Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
Official title: Observatory on Different Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Induction
Keywords: childbirth
oxytocin
prostaglandin
cervical ripening balloon
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 ).

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

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.

Non-inclusion criteria concern associated illnesses or interfering conditions:

* 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.

Primary outcomes:
measure: Overall patient satisfaction
timeFrame: 2 hours after giving birth
Secondary outcomes:
measure: Patient satisfaction evaluated via the W-DEQ questionnaire
timeFrame: 2 hours after giving birth
measure: Post-partum QEVA satisfaction questionnaire
timeFrame: 1-2 months after giving birth
measure: Different methods of labour-induction used
timeFrame: 6 months after giving birth
measure: Spontaneous vaginal deliveries
timeFrame: 48 hours maximum
measure: Rate of instrument-assisted vaginal deliveries
timeFrame: 48 hours maximum
measure: Reason for instrument-assisted vaginal deliveries
timeFrame: 48 hours maximum
measure: Type of instrument-assisted vaginal deliveries
timeFrame: 48 hours maximum
measure: Rate of Caesarian births
timeFrame: 48 hours maximum
measure: Reason for Caesarian births
timeFrame: 48 hours maximum
measure: Time from start of labour-induction to start of labour
timeFrame: 48 hours maximum
measure: Time from labour-induction to birth (Caesarian births excluded),
timeFrame: 48 hours maximum
measure: Vaginal deliveries at H12
timeFrame: 12 hours from start of induction
measure: Vaginal deliveries at H24
timeFrame: 24 hours from start of induction
measure: Vaginal deliveries at H48
timeFrame: 48 hours from start of induction
measure: Labour-induction failures
timeFrame: 12 - 18 hours
measure: Propess
timeFrame: up to 48 hours before birth
measure: Balloon/Foley bulb
timeFrame: 48 hours maximum
measure: Oxytocine
timeFrame: 48 hours maximum
measure: Epidurals
timeFrame: 48 hours maximum
measure: Bishop score evolution: Propess
timeFrame: Until birth (48 hours maximum)
measure: Bishop score evolution: Balloon/Foley bulb
timeFrame: Until birth (48 hours maximum)
measure: Bishop score evolution: Ocytocine
timeFrame: Until birth (48 hours maximum)
measure: Maternal morbidity
timeFrame: 6 months after giving birth
measure: Maternal morbidity
timeFrame: 48 hours maximum
measure: Maternal morbidity: moderate haemorrhage
timeFrame: 48 hours maximum
measure: Maternal morbidity: severe haemorrage
timeFrame: 48 hours maximum
measure: Maternal morbidity: transfusion rate
timeFrame: 48 hours maximum
measure: Maternal morbidity: amount of blood transfused
timeFrame: 48 hours maximum
measure: Maternal morbidity: rupture
timeFrame: 48 hours maximum
measure: Maternal morbidity: Chorioamniotitis
timeFrame: 48 hours maximum
measure: Maternal morbidity: infection
timeFrame: 1 week after giving birth
measure: Neonatal morbidity:asphyxia
timeFrame: 5 minutes after giving birth
measure: Neonatal morbidity: neonatal hospitalisation
timeFrame: up to 48 hours after giving birth
measure: Neonatal morbidity: infection
timeFrame: up to 48 hours after giving birth
measure: Maternal tolerance: bleeding
timeFrame: up to 48 hours after giving birth
measure: Maternal tolerance: pain due to overinflation of the balloon (Foley bulb)
timeFrame: up to 48 hours after giving birth
measure: Maternal tolerance: pain on 1st induction sequence
timeFrame: up to 48 hours before birth
measure: Maternal tolerance: pain after childbirth
timeFrame: 2 hours after giving birth
measure: Maternal tolerance: pain during childbirth
timeFrame: labour time
measure: Maternal tolerance: pain due to insert or balloon (Foley bulb)
timeFrame: up to 48 hours before birth
measure: Maternal tolerance: pain due to insert or balloon (Foley bulb) at H2
timeFrame: 2 hours after device placement
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire
state: Gard
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve Service de Gynécologie Obstétrique
state: Hérault
Study officials:
affiliation: CHU de Nîmes Service de Gynécologie Obstétrique
name: vincent letouzey, M.
role: PRINCIPAL_INVESTIGATOR
References: