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Pregnancy Denial and Attachment (Denial-attach)

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ClinicalTrials.gov Identifier: NCT02867579
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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


Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: evaluation of the child quality attachment ("Strange situation") Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pregnancy Denial and Attachment
Actual Study Start Date : April 2013
Actual Primary Completion Date : February 4, 2019
Actual Study Completion Date : May 14, 2019

Arm Intervention/treatment
women with denial pregnancy
women with denial pregnancy
Behavioral: evaluation of the child quality attachment ("Strange situation")
women without denial pregnancy
women without denial pregnancy
Behavioral: evaluation of the child quality attachment ("Strange situation")



Primary Outcome Measures :
  1. child quality attachment [ Time Frame: 18 months ]
    evaluation of the child quality attachment using "Strange situation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867579


Locations
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France
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims