Completed

NCT Number: NCT03815227

Outpatient Birth: Pilot Study

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.

Completed

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Key information

Conditions

Outpatient Birth

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz Thionville

Thionville, Moselle, 57100, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient birth

Other

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

Primary outcomes

Output rate

Time frame: Day 1

Output rate within 24 hours of birth

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Outpatient Birth: Pilot Study to Assess the Feasibility of Maternity Out the Same Date or the Next Day of the Birth

Acronym: ACCAMBU

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jan 24, 2019
Registry last updated: May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.