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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanna Rouhe, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01548131
First received: February 18, 2012
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 Intervention
Fear of Childbirth
Behavioral: Psychoeducative group therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Longitudinal Trial About Treatment for Severe Fear of Childbirth

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • number of spontaneous vaginal deliveries [ Time Frame: after delivery within a month ] [ Designated as safety issue: No ]
    delivery information is collected from patient records after delivery


Secondary Outcome Measures:
  • specific questionnaires about mental wellbeing [ Time Frame: two years after delivery ] [ Designated as safety issue: No ]
    two time-points: three months after delivery and two years after delivery

  • specific questionnaire about delivery satisfaction [ Time Frame: three months after delivery ] [ Designated as safety issue: No ]
  • specific questionnaire about early mother-infant-relationship [ Time Frame: three months after delivery ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: November 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • severe fear of childbirth

Exclusion Criteria:

  • twin pregnancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548131

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

No publications provided

Responsible Party: Hanna Rouhe, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01548131     History of Changes
Other Study ID Numbers: 228/2006
Study First Received: February 18, 2012
Last Updated: March 15, 2012
Health Authority: Finland: National Institute of Health and Welfare

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

ClinicalTrials.gov processed this record on November 27, 2014