Outpatient Birth: Pilot Study (NCT03815227)

Study 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.

Read the 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 studied

Outpatient Birth

In context

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Experimental
Outpatient birth
Maternity out the same date or the next day of the birth
Other: Outpatient birth

Interventions

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

What researchers measure

Primary outcomes

Output rate
Output rate within 24 hours of birth
Time frame: Day 1

Study locations

1 site

CHR Metz Thionville
Thionville, Moselle 57100, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03815227
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Responsible party: Sponsor
First posted: Jan 24, 2019
Start date: Jan 31, 2019
Primary completion: Jun 30, 2021
Completion: Sep 27, 2021
Last update: May 6, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Outpatient Birth: Pilot Study