ISRCTN ISRCTN73119486
DOI https://doi.org/10.1186/ISRCTN73119486
Secondary identifying numbers NTR134
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
09/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Mireille N.M. van Poppel
Scientific

Department of Public and Occupational Health/EMGO Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 4448203
Email mnm.vanpoppel@vumc.nl

Study information

Study designRandomised active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific titleReturning 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
Study acronymMom@Work
Study objectivesMany 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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedPregnancy, neonatal disorders
InterventionThe 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/01/2004
Completion date01/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants600
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2004
Date of final enrolment01/06/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

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

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
University/education

EMGO-Institute and Department of Public and Occupational Health
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Email emgo@vumc.nl
Website http://www.vumc.nl
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 29/03/2007 Yes No