NCT02867579

Brief Summary

Described in the 1970's, pregnancy denial occurs as the un-consciousness of being pregnant for several months or throughout the entire period. Body transformations are most of the time not clearly noticeable. The prevalence of this symptom could represent 2 or 3 births over 1000. The definition of pregnancy denial remains unclear due to the different nosological classifications used. There is no international consensus. Encountered terminologies are different from on author to another: pregnancy denial, pregnancy negation. The difficulties to define properly pregnancy denial accurately reflect the clinic heterogeneity of our patients when practicing on a daily basis. As a result, it is difficult to find predictive factors: any women of childbearing age, regardless her age, parity or social professional category, can be subjected to pregnancy denial. Several publications report observations of case of denial of pregnancy, few retrospective studies were realized, only two studies were interested in the future of the child, and no prospective study was interested in the future of the relation mother - child. The denial of pregnancy questions the maternal psychic functioning. No link between psychiatric disorder and denial of pregnancy was until then established. Our various clinical meetings, with mothers having presented a denial of pregnancy and reporting a difficult personal history with many breaks and events susceptibly traumatic, brought us to emit the following hypothesis: an insecure attachment of the mother would participate or at least would facilitate in the construction of a denial of pregnancy. These mothers would have a difficult access, even impossible for the infantile experiences, the essential experiences in the psychic reorganizations of the pregnancy that prepare the woman to accept her new functions of mother. The investigators hypothesize that the attachment and the development of the child, as well as interactions mothers-babies are disturbed when the woman presents a denial of pregnancy. The research will compare the maternal functioning in both constituted groups (group denial of pregnancy versus groups control), by estimating the type of maternal attachment, without omitting to look for a possible psychiatric pathology, and a personality problem at the mother. From the questioning on the psychodynamic considerations of the denial of pregnancy, and also on the future of the dyade mother-baby, the investigators construct a national program of clinical research called "Attachment and pregnancy denial", with the participation of 13 centers in France. This research is a prospective cohort examination with main objectives: study the impact of the denial of pregnancy on the pattern of attachment of the child, on the interactions of dyads mother-child and on the early development of the child with a 20-month follow-up. It's a multicenter case-control study with 13 centers (Reims, Strasbourg, Besançon, Nancy, Toulouse, Amiens, Troyes, Toulon, Limoges, Ile-de-France, Lille, Bordeaux, Paris 18ème), to find the maternal risks factors associated to pregnancy denial (secondary objectives). The main objectives of this study are: (i) studying the relationship between pregnancy denial and the attachment pattern of the child; (ii) studying the relationship between pregnancy denial and the early interactions of mother-infant dyads; (iii) studying the relationship between pregnancy denial and the early development of the child. The secondary objectives of this study are: (i) studying the relationship between the duration period from the pregnancy announcement to the delivery and the early development of a child, including the attachment pattern of a child, the early interactions of mother-infant dyads, (ii) looking for the risk factors associated to pregnancy denial, including the type of attachment, the existence of a personality disorders and/or a psychiatric pathology

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

January 21, 2026

Status Verified

June 1, 2025

Enrollment Period

5.8 years

First QC Date

August 11, 2016

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • child quality attachment

    evaluation of the child quality attachment using "Strange situation

    18 months

Study Arms (2)

women with denial pregnancy

OTHER

women with denial pregnancy

Behavioral: evaluation of the child quality attachment ("Strange situation")

women without denial pregnancy

OTHER

women without denial pregnancy

Behavioral: evaluation of the child quality attachment ("Strange situation")

Interventions

women with denial pregnancywomen without denial pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with pregnancy denial defined by a pregnancy announcement after 20 weeks of gestation and a lack of objectives perception of the pregnancy by the woman and delivery in the previous week
  • women without pregnancy denial and delivery in the previous week
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

You may not qualify if:

  • For women with pregnancy announcement after 20 weeks of gestation : No follow-up of the pregnancy due to geographical reason, social reason (no insurance coverage) and administrative reason: Mothers facing family conflicts: multiparous or marital conflicts; Mothers facing social difficulties: unemployment, hidden pregnancy to the employer.
  • women with intellectual disabilities,
  • women with acute or chronic psychotic disorders,
  • women who doesn't speak properly French,
  • born to an unidentified mother,
  • women who received a PMA treatment during pregnancy.
  • newborn with life threatening prognostic or with an organic malformation and/or genetic - abnormality observed before leaving maternity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (2)

  • Auer J, Barbe C, Sutter AL, Dallay D, Vulliez L, Riethmuller D, Gubler V, Verlomme V, Saad-Saint-Gilles S, Miton A, Tessier E, Parant O, Le Foll J, Bourgeois-Moine A, Viaux S, Dommergues M, Apter G, Belaisch-Allart J, Danion A, Nisand I, Graesslin O, Novo A, Eutrope J, Rolland AC. Pregnancy denial and early infant development: a case-control observational prospective study. BMC Psychol. 2019 Apr 11;7(1):22. doi: 10.1186/s40359-019-0290-3.

    PMID: 30971319BACKGROUND
  • Delong H, Eutrope J, Thierry A, Sutter-Dallay AL, Vulliez L, Gubler V, Saad Saint-Gilles S, Tessier E, Le Foll J, Viaux S, Apter G, Danion A, Auer J, Rolland AC; Pregnancy Denial Study Group. Pregnancy denial: a complex symptom with life context as a trigger? A prospective case-control study. BJOG. 2022 Feb;129(3):485-492. doi: 10.1111/1471-0528.16853. Epub 2021 Aug 19.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

April 1, 2013

Primary Completion

February 4, 2019

Study Completion

May 14, 2019

Last Updated

January 21, 2026

Record last verified: 2025-06

Locations