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van CCT (UK)

van CCT (UK)

Returning to work after childbirth.

- candidate number1222
- NTR NumberNTR134
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsN/A 
- Public TitleReturning to work after childbirth.
- 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.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPregnancy, Neonatal disorders
- 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.
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jun-2007
- Target number of participants600
- InterventionsThe 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 (See paragraph 9). They have to use a checklist when doing this consultation (See appendix 5).
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.
- Primary outcome1. Sick leave (during pregnancy and after maternity leave; duration and frequency);
2. Costs (of the intervention, medical consumption, sick leave);
3. Stop working.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. Mireille N.M. Poppel, van
- CONTACT for SCIENTIFIC QUERIESPhD. Mireille N.M. Poppel, van
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
Body@Work TNO VU Medical Center
- PublicationsN/A
- Brief summaryBackground:
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.

In this randomised controlled trial, 600 female employees, who are pregnant for 30 weeks, are randomised into either the intervention group or control group.
The women in the intervention group are contacted 6 weeks postpartum (during maternity leave) by their executive. The executive asks questions about their well-being, health complaints and return-to-work. When a woman thinks she will not return to work after maternity leave, she is offered help from the companies Occupational Health Services (OHS).
Women in the control group are contacted by their executive regarding return to work and are only offered help from the OHS if they are on sickness leave after maternity leave (according to the standard procedure in the Netherlands).
Outcome measures are sick leave, costs, general health, fatigue, (postpartum) depression, and back- and pelvic pain. Also risk factors for physical or psychological complaints postpartum are measured, such as health complaints during pregnancy, social support, age, birth weight of the child, childcare, etc..
First measurements are at 30 weeks pregnancy, follow-up measurements at 6, 12, 24 and 52 weeks postpartum.

In February 2005, 203 women were included in the study. The inclusion period will continue until March 2006.
- Main changes (audit trail)
- RECORD16-aug-2005 - 1-dec-2009

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