Comparison of Patient Satisfaction With Home Induction and In-patient Induction.

NCT06272591 | Completed

• 1 other identifier: IRBN1192023/CHUSTE
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated. Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction. Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital.

Conditions

Induced; Birth; Pregnancy

Keywords

Induced labour; Induction of labour; Cervical ripening; Inducing labour at home; Patient's choice of induction method; Experiences induction

Outcome Measures

Primary Outcomes (2)

• Questionnaire on patients' experience of induction in hospital and at home.

  To compare patients' experiences of their induction in hospital or at home, using a questionnaire handed out after the birth.

  Day 2

• Questionnaire on patients' satisfaction of induction in hospital and at home.

  To compare patients' satisfaction of their induction in hospital or at home, using a questionnaire handed out after the birth.

  Day 2

Secondary Outcomes (6)

• Questionnaire on patients' choice of induction method

  Day 0

• Questionnaire on reasons for choosing home induction.

  Day 0

• Maternal morbidity

  Day 3

• Maternal mortality

  Day 3

• Neonatal morbidity

  Day 3

Study Arms (1)

Pregnant women with induction indication

Any pregnant woman, with a singleton pregnancy, giving birth at Saint-Etienne University Hospital, with an indication for induction of labour from 37SA will be included. The indications may be for a maternal pathology, a maternal wish or a foetal pathology.

Other: Preliminary search in the patient's file; Other: A posteriori research in the patient's file; Other: First questionnaire : choice of induction method reason for choice; Other: Second questionnaire : experience of induction

Interventions

Preliminary search in the patient's file OTHER

Details of the information previously sought in the patient's file : age profession gender/parity physiological or pathological pregnancy indication for induction of labour gestational age at time of induction

Pregnant women with induction indication

A posteriori research in the patient's file OTHER

Data on maternal and foetal morbidity and mortality following childbirth will be collected.

Pregnant women with induction indication

First questionnaire : choice of induction method reason for choice OTHER

Given on arrival at the maternity unit to begin induction.

Pregnant women with induction indication

Second questionnaire : experience of induction OTHER

Given post-partum in the maternity unit.

Pregnant women with induction indication

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any pregnant woman with a singleton pregnancy, giving birth at the Saint-Etienne University Hospital, with an indication for induction of labour from 37SA. The indications could be for a maternal pathology, a maternal wish or a foetal pathology.

You may qualify if:

• Adult patient
• Singleton pregnancy
• Indication for induction of labour ≥ 37SA+0d
• Unfavourable cervix (Bishop\<6)
• Living less than 30 minutes' drive from hospital
• Having a relative at her side for a return home

You may not qualify if:

• Scarred uterus : previous caesarean section or myomectomy
• Premature rupture of membranes
• Fetal death in utero
• Placenta previa/accreta/percreta
• Severe maternal pathology : decompensated respiratory, cardiac, hepatic, renal, digestive or psychiatric disease, severe pre-eclampsia, severe growth retardation or anamnios
• Patient under guardianship, curatorship or safeguard of justice

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

Study Officials

• Tiphaine BARJAT, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 22, 2024
• Study Start: November 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)