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OpenTrials
Completed

NCT Number: NCT00857051

Postpartum Support: Can we Facilitate the Transition to Motherhood?

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hotline Service

Other

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

Other

A DVD addressing common stressors in the early postpartum.

Primary outcomes

  1. Stress as measure by the Cohen Perceived Stress Scale (PSS-10)

    Time frame: 2 - 3 months

Secondary outcomes

  1. Depression

    Time frame: 2 - 3 months

  2. Anxiety

    Time frame: 2 - 3 months

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Collaborators

  • Wellcome Trust

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2009
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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