Condition category
Mental and Behavioural Disorders
Date applied
15/07/2011
Date assigned
14/11/2011
Last edited
11/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Postnatal depression is a type of depression some women experience after having a baby. During pregnancy, women use healthcare centres very often and it is possible to detect their risk of having postnatal depression. The aim of this study is to assess the effects of a prenatal group program in women considered at risk of having postnatal depression.

Who can participate?
Pregnant women and their partners with an estimated family income of $ 30,000 Ca or less, with moderate or high risk factors for postpartum depression.

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The intervention group attend a prenatal group program (ten sessions of two hours duration) to prepare the entire family for childbirth. The sessions are conducted by three nurse-midwives. The control group receive the usual maternal education program. Participants in both groups complete questionnaires so that we can compare the depressive postnatal symptoms of the women in the intervention group and the control group.

What are the possible benefits and risks of participating?
The intervention group participants benefit from prenatal sessions that may be attended with young children. At the end of the study, all women received a box with various gift items: a book, diapers, bibs and bags for baby's things. There are no risks to participants. There are no medications and no advice that may endanger the participants.

Where is the study run from?
The study was carried out in three cities: Barcelona, Figueres (Spain) and Béziers (France).

When is the study starting and how long is it expected to run for?
March 2003 to June 2006.

Who is funding the study?
This study is financed by ADERMNCN, the Catalan government, the University of Montreal (Canada) and the University of Girona (Spain).

Who is the main contact?
Dr Maria Assumpta Ortiz
assumpta.ortiz@udg.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Assumpta Ortiz-Collado

ORCID ID

Contact details

University of Girona
Faculty of Nursing
Emili grahit
77
Girona
17071
Spain
+34 (0)97 241 8971
assumpta.ortiz@udg.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of a prenatal program group led to parental couples to prevent postpartum depression in women of middle and lower classes living in northern Catalonia and Southern France: a randomized longitudinal study

Acronym

Study hypothesis

Compared with a group of women who did not participate in the program, women in the intervention group consists of ten weekly sessions and based on a psychosomatic orientation present at least, a rate 6% lower risk cases of postoartum depression (PPD), once assessed 4 weeks after delivery with the Edinburgh Postnatal Depression Scale (EPDS) scale cut-off point ≥ 12.

Ethics approval

Ethical Committee for Biomedical Research, Clinic Barecelona (Comité ético de investigación biomédica, Clinic Barecelona), 17/07/2001, ref: 823

Study design

Randomized longitudinal study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Postpartum depression

Intervention

The intervention group and the control group are only one treatment that consists of ten sessions about preparation for the birth (two hours duration). These sessions are applied in groups of 6-8 couples in intervention group, with goals aimed at mothers, fathers, babies and the relationship between the participants. The groups are closed.

The control group received a single treatment; it is the usual maternal education program consists of ten sessions with women-focused goals: hygiene of pregnancy and childbirth preparation. These sessions are applied in groups of 10-14 women. The groups are open.

The number of participants in each study group is similar: n = 92 / n = 92.
The intervention program used the methodology developed by Tourné (2002). Claude-Emile Tourné is a French doctor of obstetrical medicine who designed a program to prepare the entire family to childbirth. The father, mother and siblings can participate in the sessions. The toys are available for children in the room; the experience is that the brothers listen carefully and prepare with their parents.

During these experimental sessions key questions are used, method is experimenting with different feelings and builds an individual model for this experience. The model base articulates psychosomatic perspective of childbirth, attachment theory and, cognitive theory in relation to beliefs and ideas are shared. The sessions are divided into three parts:
1. An informative part
2. Another part of discussion among participants
3. Some practical exercises

There are two sessions in which participants are those who argue the topics. During the sessions 4, 8 and 9 we displayed a 10-minute video about childbirth.

The sessions are conducted by three nurse-midwives previously prepared for the study by 28 hour formation. They don’t know the variables studied and they never had access to the data of the participants.

The control group sessions were held on days and times different from the intervention group. He asked all participants to make all the possible prenatal sessions but this was not mandatory. The intervention group participants received a weekly phone call between sessions to reinforce participation. The control group participants had no calls.

Participants were chosen at random; they lived in different places and did not know each other. The population served in two of the three centers studied live in different peripheral areas of the city or in small towns. It is difficult for these people have contact.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Four variables associated with PPD were assessed:
1. Depressive symptoms with the Edinburgh Postnatal Depression Scale (EPDS) scale
2. Amount of social support received with the Functional Social Support Questionnaire
3. Stressful events based on Holmes and Rahe
4. Relationship with the partner from Spanier’s dyadic adjustment scale (DAS)

The outcomes are measured 4 weeks after delivery.

Secondary outcome measures

1. We evaluated childbirth outcomes by specific trial questionnaires:
1.1. Preterm delivery
1.2. Infant birth weight
1.3. Somatic symptoms of the mother after delivery
1.4. Father participation in women’s and children’s medical control
2. Also evaluated aspects of the couple relationship such as
2.1. Communication
2.2. Sharing of tasks
2.3. Involving the man in childbirth process
2.4. Finally the satisfaction of the couples who participated in the experimental group sessions

Measured at 5 - 9 weeks after delivery

Overall trial start date

03/03/2003

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

The study participants were pregnant women and their partners. The average age of women was 29 years
1. Primiparous or multiparous children under 3
2. A family income ≤ $ 30,000 Ca, estimated from the type of job
3. Have moderate or high risk factors for postpartum depression assessed in the first trimester of pregnancy (use a specific screening tool validated in Europe by Riguetti-
Veltema et al, 2006).
4. Have parental partner

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

n= 529 recruited; n= 220 (selected); finaly participants n=184

Participant exclusion criteria

1. Evidence of substance abuse during pregnancy
2. Maternal psychopathology that would require women to receive psychological care to individuals during pregnancy
3. Not understanding the language (Spanish or French)
4. Belong to a privileged social class

Recruitment start date

03/03/2003

Recruitment end date

30/06/2006

Locations

Countries of recruitment

France, Spain

Trial participating centre

University of Girona
Girona
17071
Spain

Sponsor information

Organisation

ADERMNCN (Association for better childbirth in Northern Catalonia) (Spain)

Sponsor details

Hospital Maternitat
Calle Sabino Arana
1
Barcelona
08028
Spain
+34 (0)93 227 5400
vcararac@medicina.ub.es

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

French association ADERMNCN (Association of diffusion studies and intervention to further childbirth in northern Catalonia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Catalan government, grants Integrated Action (ACI)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Montreal (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Girona (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes