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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01548131
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 16, 2012
Information provided by (Responsible Party):
Hanna Rouhe, Helsinki University Central Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Fear of Childbirth Behavioral: Psychoeducative group therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Longitudinal Trial About Treatment for Severe Fear of Childbirth
Study Start Date : November 2007
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
Experimental: Psychoeducative group therapy
Psychoeducative group therapy
Behavioral: Psychoeducative group therapy
6 sessions during pregnancy and 1 after childbirth

No Intervention: Control
Women screened for fear of childbirth were taken cared by primary health care nurses and if needed referred to specialized care in hospital
Behavioral: Psychoeducative group therapy
6 sessions during pregnancy and 1 after childbirth

Primary Outcome Measures :
  1. number of spontaneous vaginal deliveries [ Time Frame: after delivery within a month ]
    delivery information is collected from patient records after delivery

Secondary Outcome Measures :
  1. specific questionnaires about mental wellbeing [ Time Frame: two years after delivery ]
    two time-points: three months after delivery and two years after delivery

  2. specific questionnaire about delivery satisfaction [ Time Frame: three months after delivery ]
  3. specific questionnaire about early mother-infant-relationship [ Time Frame: three months after delivery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • severe fear of childbirth

Exclusion Criteria:

  • twin pregnancies

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 identifier (NCT number): NCT01548131

Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Study Director: Terhi Saisto, MD, PhD Helsinki University Central Hospital

Responsible Party: Hanna Rouhe, MD, Helsinki University Central Hospital Identifier: NCT01548131     History of Changes
Other Study ID Numbers: 228/2006
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Hanna Rouhe, Helsinki University Central Hospital:
fear of childbirth
delivery mode
delivery satisfaction