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CompletedNCT03965026Updated May 28, 2019

Activity Modeling in Birth Room

An observational study in Delivery, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-28.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,100
Ages
18 Years and older
Sex
Female
01

Study summary

At this time, two methods exist to calculate a pregnant woman's presumed delivery date (DPA) : one adds 280 days to last menstruation date (Naegele rule), other estimates early pregnancy's date by imagery and adds 270 days. Unless pathology requires a trigger, this DPA estimated a early pregnancy is not re-estimated. These methods are simple and arbitrary : Mongelli and al. in 1996 found that out of nearly 40 000 unique pregnancies, only 4% give birth at determined DPA by echography and 70% at more or less 5 days. Jukic and al. in 2013 they estimate a natural variation of 37 days between pregnancy durations. Face of these poor performances, the calculating DPA method seems to be open to improvement.

Thus, the DPA calculation formula does not take into account the individual patients characteristics (age, occupation, antecedents ...), nor the follow-up data collected during pregnancy. Jukic and al. in 2013 propose a first model with some individual characteristics and medical measures (period between ovulation and early pregnancy, hormone peak) to refine the estimation. Their study gives promising results but their small patients number (a hundred) does not allow them to detect all interactions. Moreover, their method calculation is not dynamic, i.e it does not refine the DPA as pregnancy progresses. To our knowledge, no studies developing an evolutionary model over time for the DPA exist. However, objectives of a more accurate estimate of expected date are multiple and important. The investigators will mention here the two main ones :

  • A better understanding of mecanisms leading to early labour or abnormally long gestation in order to anticipate patients at risk
  • A better material and human needs anticipation, allowing a more efficient organization more adapted to activity and a care of each parturient in optimal conditions.

Our study will focus on predictive model elaboration of pregnancy duration that will evolve as the pregnancy progresses and new data collected. The investigators are considering a machine learning methodology by patient's medical record computerization at the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) since early 2016. Thus, for patients who gave birth from end of 2016, the investigators have a large amount of information on their pregnancy and follow-up on hospital servers, which motivates an automatic approach based on massive data analysis.

This study thus intends to implement advanced techniques in Machine Learning (Online Learning, Support Vector Machine ...) to advance a powerful calculation model.

02

Conditions studied

  • Delivery
03

In context

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient who gave birth at GHPSJ maternity between 01/01/2017 and 02/28/2018.

Inclusion criteria

  • Patient whose age ≥ 18 years old
  • Patient who gave birth at GHPSJ maternity between 01/01/2017 and 02/28/2018

Exclusion criteria

Exclusion Criteria:

  • Patient who expressed her opposition to participate in the study
  • Patient under guardianship or curatorship (unless consent is provided)
  • Patient who gave birth at less than 32 weeks amenorrhea
  • Pregnancy marked by MFIU (fetal death in utero)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Anticipate deliveries number 48 hours in advance

    Number of anticipate deliveries -H48 Number of deliveries at day 0 So the investigators reported the mean difference between expected and actual delivery date for included patients.

    Time frame: Day 0

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, France
08

References and documents

Publications

  • Mongelli M, Wilcox M, Gardosi J. Estimating the date of confinement: ultrasonographic biometry versus certain menstrual dates. Am J Obstet Gynecol. 1996 Jan;174(1 Pt 1):278-81. doi: 10.1016/s0002-9378(96)70408-8. PubMed 8572021 ↗
  • Jukic AM, Baird DD, Weinberg CR, McConnaughey DR, Wilcox AJ. Length of human pregnancy and contributors to its natural variation. Hum Reprod. 2013 Oct;28(10):2848-55. doi: 10.1093/humrep/det297. Epub 2013 Aug 6. PubMed 23922246 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03965026
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
May 28, 2019
Start date
Jun 22, 2018
Primary completion
Sep 30, 2018
Completion
Dec 22, 2018
Last update
May 28, 2019

Study contacts

Elie AZRIA, Professor
principal investigator · Fondation Hôpital Saint-Joseph

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 2019. You cannot join it, but the record below documents what was studied.

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