Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood

ConditionsMaternal Health Services Infant, Newborn Postnatal Care Breast Feeding Maternal-Child Relations Postpartum Depression (PPD)Mental Health Lactation Breast Feeding, Exclusive Patient Satisfaction and Experience With Integrative Therapies Neonatal Jaundice Maternal Behavior Body Weight Decreased Breast Feeding of Healthy Full Term Infants Lactation Mastitis Lactation Disorder - Postpartum Condition or Complication Lactation Disorder With Baby Delivered Lactation; Insufficient, Partial

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-50

SponsorMedical University of Vienna

About this trial

The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied. One is a nurse-led, seperate model of care and the other is a midwife-led, integrative model of care. Participants are healthy women between the ages of 18 and 50. They gave birth between 36+0 and 42+0 weeks of pregnancy and had a child. The type of birth is not an inclusion or exclusion criteria. Our hypotheses are: i) that maternal satisfaction with care in a midwife-led, integrative care model is higher than in separate maternal and infant care; ii) that a positive postpartum experience leads to earlier and increased maternity competence; iii) that a higher breastfeeding rate at the time of the survey in the fourth month can be achieved through integrative care. Participants will be randomly assigned, after birth of their child, to either the group cared for by a nurse or the group cared for by a midwife.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18 to 50 years at the time of delivery

Classified as "low-risk" by the obstetric team in the delivery room

Gestational age at birth between 36+0 and 42+0 weeks

Singleton birth (only one child born)

Disqualifiers

Women younger than 18 or older than 50 at the time of delivery

Classified as "high-risk" by the obstetric team

Multiple birth (e.g., twins, triplets)

No intention or ability to breastfeed the newborn

Trial design

Design model

Parallel

Treatments tested in this trial

Integrative care
Other intervention
Joint care of mother and child by just one healthcare professional

Treatment groups

784 Participants

are divided into 2 treatment groups

Group A: Nursing care model - control groupNo intervention 0 interventions

Group B: Midwife-led or integrative care model - intervention groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Maternal Functioning 1a

The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning

Time frame

within 3 days postpartum

Maternal Functioning 1b

Time frame

Approximately 28 days postpartum

Maternal Functioning 1c

Time frame

Approximately 120 days postpartum

Secondary outcomes

Effectiveness of breastfeeding

The Beginning Breastfeeding Survey-Cumulative (BBS-C) has 24 items, that rated on a scale from 1 ( Always) to 5 (Never). A possible total score ranging from 24 to 120. Higher total cumulative scores on the BBS-C indicate greater breastfeeding effectiveness for the mother and the newborn.

Time frame

Within 3 days postpartum

Maternal satisfaction with postnatal care

The WOMen's views of Birth Postnatal Satisfaction Questionnaires (WOMBPNSQ) has 36 items, that rated from 1 (strongly agree) to 7 (strongly disagree). The total score ranges from 36 to 252.

Time frame

Approximately 28 days postpartum

Detecting symptoms of postnatal depression

The Edinburgh Postnatal Depression Scale (EPDS) was developed as 10 items instrument, that rated on a scale from 0 to 3 by order of statements. The total score of the scale could be from 0 to 30, where the higher score indicates a higher intensity of depression symptoms.

Time frame

Approximately 120 days postpartum

Other outcomes

Breastfeeding process and exclusive breastfeeding rate 7a

They are asked whether they are still breastfeeding, whether they are exclusive breastfeeding, when and what they are feeding and what plans they have for the future

Time frame

Approximately 28 days postpartum

Breastfeeding process and exclusive breastfeeding rate 7b

They are asked whether they are still breastfeeding, whether they are exclusive breastfeeding, when and what they are feeding and what plans they have for the future

Time frame

Approximately 120 days postpartum

Progression of neonatal jaundice

Neonatal jaundice and the question of whether it needs to be treated

Time frame

Within 3 days postpartum

Weight progression

Onset postpartum weight loss below/above 10%

Time frame

Within 3 days postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov

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