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Postpartum Support: Can we Facilitate the Transition to Motherhood?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857051
First Posted: March 6, 2009
Last Update Posted: September 25, 2009
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.
Collaborator:
Wellcome Trust
Information provided by:
American University of Beirut Medical Center
  Purpose
We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing.

Condition Intervention
Stress Other: Hotline Service Other: Film

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Postpartum Support: Can we Facilitate the Transition to Motherhood?

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • Stress as measure by the Cohen Perceived Stress Scale (PSS-10) [ Time Frame: 2 - 3 months ]

Secondary Outcome Measures:
  • Depression [ Time Frame: 2 - 3 months ]
  • Anxiety [ Time Frame: 2 - 3 months ]

Estimated Enrollment: 552
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A 22 minute DVD that discusses common stressor in the early postpartum.
Other: Film
A DVD addressing common stressors in the early postpartum.
Experimental: 2
A 24 hour hotline available for the first 3 months postpartum.
Other: Hotline Service
A 24 hour hotline to answer questions about baby care or mother self-care. Hotline will be answered by a midwife and answers will be based on algorithms.
Experimental: 3
Both the film and the hotline will be given to this arm.
Other: Hotline Service
A 24 hour hotline to answer questions about baby care or mother self-care. Hotline will be answered by a midwife and answers will be based on algorithms.
Other: Film
A DVD addressing common stressors in the early postpartum.
No Intervention: 4
A CD of children's music will be given to mothers in this arm.

Detailed Description:

The postpartum period is a very stressful experience for most mothers. It is generally accepted that women are physically and psychologically stressed during the postpartum. After delivery a woman may have worries about the health of her baby and her own health, as well as the changes in her body, their impact on her sexual life and her relationship with her husband. In addition, she may have financial concerns, concerns about breastfeeding, and be worried about bonding with her baby.

First-time mothers also have to adapt to their new role as mothers and may be worried about their abilities to take care of the baby. This may cause first-time mothers to develop postpartum depression and other emotional problems. First-time mothers can feel overwhelmed, exhausted, and isolated in their new roles.

We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing. The hotline will be answered by a trained midwife.

Women will be recruited from all hospitals in Beirut after delivery and before they leave the hospital. If they agree to participate in the study, they will be randomly assigned to receive the film, the hotline service, both the film and the hotline service, or a CD containing children's songs. Women will be visited at home at 2 - 3 months after delivery by a researcher to complete questionnaires designed to measure stress, depression and anxiety in the postpartum.

Participants will not receive any financial compensation for participating in the study. Although women may benefit from the interventions, we will not know that until we complete the study. However, participation in this study may benefit mothers in the future if we find that the hotline or educational video are useful. There are no risks associated with participation in this study.

Confidentiality of the collected information will be ensured. All information collected will be used for research purposes and will be kept anonymous.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy first-time mothers with singleton baby delivered at term with no complications.

Exclusion Criteria:

  • Mothers with chronic health problems,
  • Pregnancy complications, OR
  • Infants with congenital problems or conditions requiring admission to the intensive care nursery.
  Contacts and Locations
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): NCT00857051


Locations
Lebanon
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Wellcome Trust
Investigators
Principal Investigator: Hibah Osman, MD, MPH American University of Beirut Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hibah Osman, MD, MPH, American University of Beirut
ClinicalTrials.gov Identifier: NCT00857051     History of Changes
Other Study ID Numbers: FM.HO.04
First Submitted: March 5, 2009
First Posted: March 6, 2009
Last Update Posted: September 25, 2009
Last Verified: March 2009

Keywords provided by American University of Beirut Medical Center:
Stress