Outpatient Birth: Pilot Study

NCT ID: NCT03815227

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-09-27

Brief Summary

The diminution of the average length stay (ALS) in French maternity is a clear evolution, the objective of the draft law on social security is to reduce the ALS to equal other OECD countries. The over-medicalization of maternal health raises the question of relevant and iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed their wish for an individual support and more physiological respectful. A more-effective Professional coordination is expected where the midwife is a major player.

Detailed Description

The aim of the study is to identify and evaluate an outpatient birth path during the first 24 hours after the birth.

Conditions

Outpatient Birth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Outpatient birth

Maternity out the same date or the next day of the birth

Group Type: EXPERIMENTAL

Outpatient birth

Intervention Type: OTHER

Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife

Interventions

Outpatient birth

Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• With no multiple pregnancy, of less than 20 weeks of gestation
• With a BMI between 17,5 and 35 kg/m²
• is able to understand research's informations
• affiliated member of the social security system
• Have given an informed consent

Exclusion Criteria

• With psychological vulnerability, social vulnerability, addictions and high dependency
• With an unbalanced chronic pathology or susceptible to contraindicated a physiologic birth
• With history of caesarean, foeto-maternal incompatibility, gestational hypertension, pre-eclampsia, HELLP syndrome or retro-placental hematoma, sphincter tear
• With history of birth with perinatal asphyxia and sequelae or an unexplained perinatal death
• With history of puerperal psychosis
• Under guardianship

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHR Metz Thionville

Thionville, Moselle, France

Countries

France

Other Identifiers

2016-06-CHRMT

Identifier Type: -

Identifier Source: org_study_id