Outpatient Birth: Pilot Study (ACCAMBU)

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

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.

Study Overview

• Status: Completed
• Conditions: Outpatient Birth
• Intervention / Treatment: Other: Outpatient birth

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Moselle
    • Thionville, Moselle, France, 57100
      • CHR Metz Thionville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient birth; Maternity out the same date or the next day of the birth	Other: Outpatient birth; Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Output rate	Output rate within 24 hours of birth	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2016-06-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No