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A Randomized Longitudinal Trial About Treatment for Severe Fear of Childbirth (LINNEA)

15 mars 2012 uppdaterad av: Hanna Rouhe, Helsinki University Central Hospital

Site of research: Helsinki University Central Hospital (HUCH), Department of Obstetrics and Gynaecology and University of Helsinki Department of Psychology, in collaboration with Karolinska University Hospital in Stockholm, Sweden

In Finland and in Sweden, fear of childbirth is one of the most common reasons for consultation of obstetrician, and for an elective caesarean section. Approximately 5 to 6% of pregnant women suffer from severe fear of childbirth, which disturbs family-life and working and prevents the preparation to normal childbirth and parenthood. It represents as nightmares, panic attacks, anxiety, and as numerous physical complaints. After giving birth it can be difficult for these women to form an early mother-infant-relationship. Their risk for puerperal depression is also increased.

Finland and Sweden have both a long tradition in research of this field. In Finland, the investigators research group started the first out-patient clinic for fearful pregnant women in HUCH in1996. Different strategies how to treat fear of childbirth have been applied to clinical practise. Studies on the treatment for fear of childbirth are, however, scanty. Some descriptive studies have showed that far more than one half of patients can, after the treatment, prepare to a normal vaginal delivery and caesarean without a medical indication can be avoided. The aim of the treatment should be both to avoid unnecessary caesareans, increase the number of uneventful vaginal deliveries and to help the pregnant couple to prepare to parenthood, as well as to prevent puerperal depression.

In this study, psychotherapeutic group psychoeducation is studied as promising treatment for severe fear of childbirth. To screen fear of childbirth, all women coming to ultrasound screening at the 18 to 20 gestational week in HUCH are asked to fill in a specific questionnaire. Those nulliparous women whose score for fear exceeds 95th percentile are randomized to intervention and to control group.

The intervention group is invited to start a psychotherapeutic group therapy based on cognitive and psychodynamic therapy combined with training in relaxation. Each group consists of six nulliparous women and meets six times during pregnancy 120 minutes at a time. Between the sessions the patients fill in a homework questionnaire. One session focuses on the partner's role and the partners are present then. Three months after delivery, the groups meet once more.

The women in the control group stay in the care of community midwives and general physicians. If needed, they are referred to out-patient clinic in the maternity hospital where their fear is treated according the clinical practice of that hospital, mainly support from obstetrician or midwife.

The women and their partners in both groups are asked, approximately one month after the screening and one month before the due date of delivery, to fill in the questionnaires examining depression, self-esteem, general anxiety, social support, marital satisfaction, personal projects and concerns, and efficacy concerning childbirth and maternity. After childbirth, data about the childbirth will be collected. Three months and two years after childbirth mothers and fathers in both groups receive again a psychosocial questionnaires.

The aim of the study is to help the authorities to organize the treatment for fear of childbirth in their districts by examining the benefits of the treatment also in long-run. The investigators hope the results would lead to production of Current Care guidelines for fear of childbirth.

Studieöversikt

Status

Avslutad

Studietyp

Interventionell

Inskrivning (Faktisk)

370

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • HUS
      • Helsinki, HUS, Finland, 00029
        • Helsinki University Central Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • severe fear of childbirth

Exclusion Criteria:

  • twin pregnancies

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Psychoeducative group therapy
6 sessions during pregnancy and 1 after childbirth
Inget ingripande: Control
Women screened for fear of childbirth were taken cared by primary health care nurses and if needed referred to specialized care in hospital
6 sessions during pregnancy and 1 after childbirth

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
number of spontaneous vaginal deliveries
Tidsram: after delivery within a month
delivery information is collected from patient records after delivery
after delivery within a month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
specific questionnaires about mental wellbeing
Tidsram: two years after delivery
two time-points: three months after delivery and two years after delivery
two years after delivery
specific questionnaire about delivery satisfaction
Tidsram: three months after delivery
three months after delivery
specific questionnaire about early mother-infant-relationship
Tidsram: three months after delivery
three months after delivery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: Terhi Saisto, MD, PhD, Helsinki University Central Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2007

Primärt slutförande (Faktisk)

1 februari 2012

Avslutad studie (Faktisk)

1 februari 2012

Studieregistreringsdatum

Först inskickad

18 februari 2012

Först inskickad som uppfyllde QC-kriterierna

7 mars 2012

Första postat (Uppskatta)

8 mars 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 mars 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 mars 2012

Senast verifierad

1 mars 2012

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 228/2006

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