Postpartum Support: Can we Facilitate the Transition to Motherhood?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

NCT02807662

Posttraumatic Stress Disorder

COMPLETED NA

Prevention of Postpartum Depression in Low-Income Women

NCT00053651

Depression, Postpartum

COMPLETED PHASE1

Better Understanding Patient Perspectives of an Educational Tool for Postpartum Hypertensive Patients

NCT06996496

Hypertension, Pregnancy Induced

ACTIVE_NOT_RECRUITING NA

Social Media Intervention for Postpartum Depression

NCT02355067

Postpartum Depression Parenting

COMPLETED NA

Assessing the CenteringPregnancy Planning to Parent Innovation

NCT02856711

Stress, Psychologic Pregnancy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

A 22 minute DVD that discusses common stressor in the early postpartum.

Group Type EXPERIMENTAL

Film

Intervention Type OTHER

A DVD addressing common stressors in the early postpartum.

2

A 24 hour hotline available for the first 3 months postpartum.

Group Type EXPERIMENTAL

Hotline Service

Intervention Type 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.

3

Both the film and the hotline will be given to this arm.

Group Type EXPERIMENTAL

Hotline Service

Intervention Type 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

Intervention Type OTHER

A DVD addressing common stressors in the early postpartum.

4

A CD of children's music will be given to mothers in this arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Film

A DVD addressing common stressors in the early postpartum.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No