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Postpartum care 2.0: the effect of flexible postpartum care hours on the success rate of breastfeeding, experienced empowerment and quality of care by the mother during and after postpartum period.


- candidate number27109
- NTR NumberNTR6281
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2017
- Secondary IDsNL61474.091.17 CCMO toetsingonline (ABR-formulier)
- Public TitlePostpartum care 2.0: the effect of flexible postpartum care hours on the success rate of breastfeeding, experienced empowerment and quality of care by the mother during and after postpartum period.
- Scientific TitlePostpartum care 2.0: does flexible distribution and intermission of postpartum care have an effect on the success rate of breastfeeding, experienced empowerment and quality of care by the mother during and after postpartum period?
- ACRONYMPostpartum care 2.0
- hypothesisThe Dutch maternity care model with in-home postpartum care is unique. This uniqueness results in little to no scientific knowledge on the effectiveness and efficiency of in-home postpartum care. Filling the knowledge gap and following the trend of personalized care are prerequisites in preserving this form of maternity care. Therefore this study researches the effect of flexible distribution and intermission of postpartum care hours on the health of mother and child.
- Healt Condition(s) or Problem(s) studiedBreastfeeding , Disability, Suprastructure complications, postpartum/puerperium problems
- Inclusion criteriapregnant women who have the intention (in week 30 of pregnancy; during intake by postpartum care organisation) to breastfeed
- Exclusion criteriapregnant women who do not have the intention (in week 30 of pregnancy; during intake by postpartum care organisation) to breastfeed
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate31-aug-2019
- Target number of participants1114
- InterventionsIntervention group:
Clients are offered the opportunity for flexible planning of their postpartum care hours (i.e. distribution and/or intermission), without making any additional health care costs. This means that the indicated 24-49 postpartum care hours may be distributed throughout the whole day and on noncontiguous days (to a maximum of 14 days). Additional indicated postpartum care (up to 80hrs) may also be distributed throughout the whole day and noncontiguous days (to a maximum of 14 days). Furthermore, a decrease of the number of postpartum care hours is also possible. In this case, the guarantee of continuity of care is a vital condition.
(Re)distribution of postpartum care hours is always done in consultation with the client, the healthcare provider (who accompanies and is medically responsible during parturition and childbed) and postpartum caregiver; in a similar manner as is done in the current situation using the LIP.

Control group:
Clients receive the current package of postpartum care hours (i.e. 24-49 hours in 8 continguous days), possibly followed by an additional indication of hours (up to 80hrs) within 10 contiguous days (i.e. 2 extra days).
- Primary outcomeOur primary study outcome is successful breastfeeding (purely breastfeeding, no supplements). Successful breastfeeding is considered as a perfect surrogate outcome measure for health benefits of mother and newborn in the short and long term. Meta-analyses show that breastfeeding protects children against health infections, improves childs' intelligence and possibly reduces chances of obesity and diabetes. Furthermore, breastfeeding also protects women against breast cancer and ovarian cancer and diabetes type 2. It is even stated that worldwide breastfeeding initiatives can reduce thousands of deaths among children under 5years and prevent thousands of deaths due to breastcancer among women.
- Secondary outcome- Experienced quality of postpartum care by mother;

- Self-reliance of mother at the end of the postpartum period;

- Experience with the intervention by caregiver who accompanied and was medically responsible for parturition and childbed (e.g. midwife), postpartum care consultant, postpartum caregiver, lactation consultant and youth caregiver;

- Cost-effectiveness of the intervention.
- TimepointsPrimary outcome:
Measured at day 1 after birth, at the end of the postpartum care period and at the first two visits to the JGZ (youth care).

Secondary outcomes:
- experienced quality; measured 6 weeks after childbirth by means of ReproQ;

- experienced self-reliance; measured 3 weeks after childbirth by following two questions:

- How did you experience the first few days after the postpartum caregiver was gone (5 point Likert scale, very bad to very good)?
- How often and which healthcare provider did you contact after the postpartum caregiver was gone until the first visit to the JGZ (youth care)?

- experience of intervention by caregivers; measured during 2 year intervention by means of focus group discussions and questionnaires, focus on the barriers and possibilities of intervention;

- cost-effectives; measured 3 weeks after birth by comparing the actual postpartum care hours and healthcare needs of client after postpartum care period until first visit to JGZ (youth care).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Fleur Lambermon
- CONTACT for SCIENTIFIC QUERIES Noortje Duijnhoven van
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryThe Dutch maternity care model with in-home postpartum care is unique. This uniqueness results in little to no scientific knowledge on the effectiveness and efficiency of in-home postpartum care. Filling the knowledge gap and following the trend of personalized care are prerequisites in preserving this form of maternity care. Therefore this study researches the possibility of flexible distribution and intermission of postpartum care hours. It concerns a practice based innovative research model which, without extension of postpartum hours, analyses whether distribution and intermission of postpartum care hours benefits the health of mother and child.
It is expected that this planning flexibility of postpartum care hours will have a positive effect on the health of mother and newborn (in terms of successful breastfeeding, experienced quality and self-reliance by the client and her partner), a better and more efficient cooperation between different health institutes and a smoother start for youth care organisations. Scientific evidence of essential and effective postpartum care can contribute to an improved maternity care system and its goal to give all mothers and newborns a perfect kick-off of life. To a greater extent, this new generated knowlegde can reduce maternal and perinatal mortality and morbidity in the long run.
- Main changes (audit trail)15-sep-2017 -IK:

Timepoints:
'Primary outcome:
Measured at day 1 after birth, at the end of the postpartum care period and at the first two visits to the JGZ (youth care)'

replaced by:

'Primary outcome:
Measured at day 1 after birth, at the end of the postpartum care period and at 4 weeks postpartum.'


'Secondary outcomes:
- experienced quality; measured 6 weeks after childbirth by means of ReproQ;
- experienced self-reliance; measured 3 weeks after childbirth by following two questions:
- How did you experience the first few days after the postpartum caregiver was gone (5 point Likert scale, very bad to very good)?
- How often and which healthcare provider did you contact after the postpartum caregiver was gone until the first visit to the JGZ (youth care)?
- experience of intervention by caregivers; measured during 2 year intervention by means of focus group discussions and questionnaires, focus on the barriers and possibilities of intervention;
- cost-effectives; measured 3 weeks after birth by comparing the actual postpartum care hours and healthcare needs of client after postpartum care period until first visit to JGZ (youth care).'

replaced by:

'Secondary outcomes:
- experienced quality; measured 4 weeks after childbirth by means of QCLiK questionnaire;
- experienced self-reliance; measured 4 weeks after childbirth by means of CLiK questionnaire;
- experience of intervention by caregivers; measured during 2 year intervention by means of focus group discussions and questionnaires, focus on the barriers and possibilities of intervention;
- cost-effectives; measured 4 weeks after birth by comparing the actual postpartum care hours and healthcare needs of client after postpartum care period. By adding the following question to the questionnaire (sent 4 week postpartum)- How often and which healthcare provider did you contact after the postpartum caregiver was gone?'
- RECORD19-apr-2017 - 15-sep-2017


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