Outpatient Birth: Pilot Study

Outpatient Birth Clinical Trial

— ACCAMBU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815227
• Other study ID #: 2016-06-CHRMT
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 27, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Outpatient Birth

Intervention

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

Locations

Country	Name	City	State
France	CHR Metz Thionville	Thionville	Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Output rate	Output rate within 24 hours of birth	Day 1