Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.momatwork.nl

Contact information

Type

Scientific

Primary contact

Dr Mireille N.M. van Poppel

ORCID ID

Contact details

Department of Public and Occupational Health/EMGO Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448203
mnm.vanpoppel@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR134

Study information

Scientific title

Returning to work after childbirth: the effectiveness of the first contact by an executive with an employee during maternity leave on sick leave and work disability postpartum

Acronym

Mom@Work

Study hypothesis

Many women experience health problems during the first year after childbirth.

Common postpartum problems are fatigue, disturbed sleep, postpartum depression, back and pelvic pain. Those problems are often perceived as being unavoidable and 'all in the game'. However, frequently these problems lead to limitations in daily activities and to sick leave. In the Netherlands sick leave is higher during pregnancy and the first period postpartum than during other periods. About 30% of the women were absent from work due to health problems after maternity leave in 2002.

In the Netherlands, there is no contact with an occupational physician during maternity leave, not even when women experience health problems. Furthermore, women often wait for seeking medical care for their problems, frequently until their maternity leave is almost over. Therefore, the complaints may have existed for a considerable time before an intervention starts, while early intervention after complaints seems to be important for a good prognosis.

The aim of this study is to evaluate the effectiveness of an early consultation by an executive with an employee during maternity leave on health problems and sick leave, and to assess which factors contribute to return-to-work after maternity leave.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Pregnancy, neonatal disorders

Intervention

The women in the intervention group will be consulted 6 weeks postpartum during maternity leave by their executive, and in some cases by a case manager or a staff member of the personnel department. This executive will phone, or visit the women. Prior to this consultation the executive receives an information package. He or she will be instructed carefully to ask questions about the women's well-being, complaints, and return to work. They have to use a checklist when doing this consultation.

When a woman has the expectation that she will not return to work after maternity leave due to medical complaints, she will have the possibility to receive a consultation by a staff member of the Occupational Health Services (OHS). The executive will phone the OHS in case of need for medical intervention (or will follow the standard sick-listed procedure of the company). The OHS will call the woman to make an appointment within one week with an occupational physician or other consultant.

When a woman has no complaints and/or expects no problem to return-to-work, the executive will do nothing. When a woman has doubts or is uncertain if she is able to return-to-work, the executive will call again after 2 weeks. The executive uses the same checklist again.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sick leave (during pregnancy and after maternity leave; duration and frequency)
2. Costs (of the intervention, medical consumption, sick leave)
3. Stop working

Secondary outcome measures

1. Health status/quality of life
2. Complaints (pregnancy-related pelvic and back pain, fatigue and depressive complaints (postpartum depression, distress)
3. Satisfaction with intervention
4. Adaptation of working hours or work tasks

Overall trial start date

01/01/2004

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Voluntary participation (giving informed consent)
2. Age: between 18 and 45 years
3. Pregnant less than 32 weeks
4. Being employed before and after maternity leave, for a minimum of 12 hours per week
5. Good reading, writing and understanding of the Dutch language

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

Participant exclusion criteria

1. Delivery before 34 weeks of pregnancy
2. Definitely not returning to work after delivery, meaning one has submitted one’s resignation, or end of contract
3. Not returning to the same employer
4. Receiving a disability benefit or having submitted an application for a disability benefit

Recruitment start date

01/01/2004

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Public and Occupational Health/EMGO Instituut
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

EMGO-Institute and Department of Public and Occupational Health
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
emgo@vumc.nl

Sponsor type

University/education

Website

http://www.vumc.nl

Funders

Funder type

Research organisation

Funder name

Body@Work TNO - Vrije University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17394629

Publication citations

  1. Protocol

    Stomp-van den Berg SG, van Poppel MN, Hendriksen IJ, Bruinvels DJ, Uegaki K, de Bruijne MC, van Mechelen W, Improving return-to-work after childbirth: design of the Mom@Work study, a randomised controlled trial and cohort study., BMC Public Health, 2007, 7, 43, doi: 10.1186/1471-2458-7-43.

Additional files

Editorial Notes