Postpartum Support: Can we Facilitate the Transition to Motherhood?

Stress Clinical Trial

Official title:

Postpartum Support: Can we Facilitate the Transition to Motherhood?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857051
• Other study ID #: FM.HO.04
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: September 24, 2009
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: March 2009
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stress

Intervention

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.
• Film
A DVD addressing common stressors in the early postpartum.

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Wellcome Trust

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress as measure by the Cohen Perceived Stress Scale (PSS-10)		2 - 3 months	No
Secondary	Depression		2 - 3 months	No
Secondary	Anxiety		2 - 3 months	No