Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2016

Open Access 01-12-2016 | Study protocol

Group based prenatal care in a low-and high risk population in the Netherlands: a study protocol for a stepped wedge cluster randomized controlled trial

Authors: Birgit S. van Zwicht, Matty R. Crone, Jan M. M. van Lith, Marlies E. B. Rijnders

Published in: BMC Pregnancy and Childbirth | Issue 1/2016

Login to get access

Abstract

Background

CenteringPregnancy (CP) is a multifaceted group based care-model integrated in routine prenatal care, combining health assessment, education, and support. CP has shown some positive results on perinatal outcomes. However, the effects are less obvious when limited to the results of randomized controlled trials: as there are few trials and there is a variation in reported outcomes. Furthermore, former research was mostly conducted in the United States of America and in specific (often high risk) populations. Our study aims to evaluate the effects of CP in the Netherlands in a general population of pregnant women (low and high risk). Furthermore we aim to explore the mechanisms leading to the eventual effects by measuring potential mediating factors.

Design

We will perform a stepped wedge cluster randomized controlled trial, in a Western region in the Netherlands. Inclusion criteria are <24 weeks of gestation and able to communicate in Dutch (with assistance). Women in the control period will receive individual care, women in the intervention period (starting at the randomized time-point) will be offered the choice between individual care or CP. Primary outcomes are maternal and neonatal morbidity, retrieved from a national routine database. Secondary outcomes are health behavior, psychosocial outcomes, satisfaction, health care utilization and process outcomes, collected through self-administered questionnaires, group-evaluations and individual interviews. We will conduct intention-to-treat analyses. Also a per protocol analysis will be performed comparing the three subgroups: control group, CP-participants and non-CP-participants, using multilevel techniques to account for clustering effects.

Discussion

This study contributes to the evidence regarding the effect of CP and gives a first indication of the effect and implementation of CP in both low and high-risk pregnancies in a high-income Western society other than the USA. Also, measuring factors that are hypothesized to mediate the effect of CP will enable to explain the mechanisms that lead to effects on maternal and neonatal outcomes.

Trial registration

Dutch Trial Register, NTR4178, registered September 17th 2013.
Literature
1.
2.
Lanting CI, van Wouwe JP, van den Burg I, Segaar D, van der Pal-de Bruin KM. Smoking during pregnancy: trends between 2001 and 2010. Ned Tijdschr Geneeskd. 2012;156:A5092.PubMed
3.
Henrichs J, Schenk J, Roza S, Van den Berg M, Schmidt H, Steegers E, et al. Maternal psychological distress and fetal growth trajectories: the Generation R Study. Psychol Med. 2010;40:633–43.CrossRefPubMed
4.
Mozurkewich EL, Luke B, Avni M, Wolf FM. Working conditions and adverse pregnancy outcome: a meta-analysis. Obstet Gynecol. 2000;95:623–35.PubMed
5.
Meyboom-de Jong B, de Jong-van den Berg LT. Pregnancy and drug use. Ned Tijdschr Geneeskd. 1992;136:1843–7.PubMed
6.
Evers IM, de Valk HW, Visser GH. Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ (Clinical Research ed). 2004;328:915.CrossRef
7.
Troe EJ, Bos V, Deerenberg IM, Mackenbach JP, Joung IM. Ethnic differences in total and cause-specific infant mortality in The Netherlands. Paediatr Perinat Epidemiol. 2006;20:140–7.CrossRefPubMed
8.
Alderliesten M, Vrijkotte T, Van Der Wal M, Bonsel G. Late start of antenatal care among ethnic minorities in a large cohort of pregnant women. BJOG. 2007;114:1232–9.CrossRefPubMed
9.
de Graaf J, Ravelli A, Wildschut H, Denktaş S, Voorham T, Bonsel G, et al. Perinatale uitkomsten in de vier grote steden en de prachtwijken in Nederland. Ned Tijdschr Geneeskd. 2008;152:2734–40.PubMed
10.
Schölmerich VL, Erdem Ö, Borsboom G, Ghorashi H, Groenewegen P, Steegers EA, et al. The association of neighborhood social capital and ethnic (minority) density with pregnancy outcomes in the Netherlands. PLoS One. 2014;9:e95873.CrossRefPubMedPubMedCentral
11.
Institute of Medicine. Speaking of Health: Assessing Health Communication Strategies for Diverse Populations. Washington, DC: The National Academies Press; 2002.
12.
Jepson RG, Harris FM, Platt S, Tannahill C. The effectiveness of interventions to change six health behaviours: a review of reviews. BMC Public Health. 2010;10:538.CrossRefPubMedPubMedCentral
13.
Kreuter MW, Lukwago SN, Bucholtz RD, Clark EM, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav. 2003;30:133–46.CrossRefPubMed
14.
15.
Massey Z, Rising SS, Ickovics J. CenteringPregnancy group prenatal care: promoting relationship‐centered care. J Obstet Gynecol Neonatal Nurs. 2006;35:286–94.CrossRefPubMed
16.
Lorig KR, Holman HR. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26:1–7.CrossRefPubMed
17.
Ickovics JR, Kershaw TS, Westdahl C, Magriples U, Massey Z, Reynolds H, et al. Group prenatal care and perinatal outcomes: a randomized controlled trial. Obstet Gynecol. 2007;110:330.CrossRefPubMedPubMedCentral
18.
Zantinge EM, Seesing FM, Tol FE, Raats CJ, Spreeuwenberg PM, van Dulmen AM. Shared Medical Appointments: experiences of patients and care givers. Ned Tijdschr Geneeskd. 2009;153:A828.PubMed
19.
20.
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002;288:2469–75.CrossRefPubMed
21.
Bandura A. Swimming against the mainstream: the early years from chilly tributary to transformative mainstream. Behav Res Ther. 2004;42:613–30.CrossRefPubMed
22.
Sol BG, van der Bijl JJ, Banga JD, Visseren FL. Vascular risk management through nurse-led self-management programs. J Vasc Nurs. 2005;23:20–4.CrossRefPubMed
23.
24.
Hesselink AE, Harting J. Process evaluation of a multiple risk factor perinatal programme for a hard-to-reach minority group. J Adv Nurs. 2011;67:2026–37.CrossRefPubMed
25.
Baldwin KA. Comparison of selected outcomes of CenteringPregnancy versus traditional prenatal care. J Midwifery Womens Health. 2006;51:266–72.CrossRefPubMed
26.
Catling CJ, Medley N, Foureur M, Ryan C, Leap N, Teate A, Homer CS. Group versus conventional antenatal care for women. Cochrane Database Syst Rev. 2015;2:Cd007622.
27.
Jafari F, Eftekhar H, Fotouhi A, Mohammad K, Hantoushzadeh S. Comparison of maternal and neonatal outcomes of group versus individual prenatal care: a new experience in Iran. Health Care Women Int. 2010;31:571–84.CrossRefPubMed
28.
Teate A, Leap N, Rising SS, Homer CS. Women's experiences of group antenatal care in Australia—the CenteringPregnancy Pilot Study. Midwifery. 2011;27:138–45.CrossRefPubMed
29.
Grady MA, Bloom KC. Pregnancy outcomes of adolescents enrolled in a CenteringPregnancy program. J Midwifery Womens Health. 2004;49:412–20.CrossRefPubMed
30.
Kennedy HP, Farrell T, Paden R, Hill S, Jolivet RR, Cooper BA, Rising SS. A randomized clinical trial of group prenatal care in two military settings. Mil Med. 2011;176:1169–77.CrossRefPubMed
31.
Ickovics JR, Earnshaw V, Lewis JB, Kershaw TS, Magriples U, Stasko E, et al. Cluster Randomized Controlled Trial of Group Prenatal Care: Perinatal Outcomes Among Adolescents in New York City Health Centers. Am J Public Health. 2016;106(2):359–365.
32.
Klima CS. Centering pregnancy: a model for pregnant adolescents. J Midwifery Womens Health. 2003;48:220–5.CrossRefPubMed
33.
Trudnak TE, Arboleda E, Kirby RS, Perrin K. Outcomes of Latina women in CenteringPregnancy group prenatal care compared with individual prenatal care. J Midwifery Womens Health. 2013;58:396–403.CrossRefPubMed
34.
Robertson B, Aycock DM, Darnell LA. Comparison of centering pregnancy to traditional care in Hispanic mothers. Matern Child Health J. 2009;13:407–14.CrossRefPubMed
35.
Rising SS. Centering pregnancy: an interdisciplinary model of empowerment. J Nurse Midwifery. 1998;43:46–54.CrossRefPubMed
36.
37.
Gartner FR, de Miranda E, Rijnders ME, Freeman LM, Middeldorp JM, Bloemenkamp KW, et al. Good reliability and validity for a new utility instrument measuring the birth experience, the Labor and Delivery Index. J Clin Epidemiol. 2015;68:1184–94.CrossRefPubMed
38.
Hodnett ED, Simmons‐Tropea DA. The Labour Agentry Scale: psychometric properties of an instrument measuring control during childbirth. Res Nurs Health. 1987;10:301–10.CrossRefPubMed
39.
Yali AM, Lobel M. Coping and distress in pregnancy: An investigation of medically high risk women. J Psychosom Obstet Gynaecol. 1999;20:39–52.CrossRefPubMed
40.
Yali AM, Lobel M. Stress-resistance resources and coping in pregnancy. Anxiety Stress Coping. 2002;15:289–309.CrossRef
41.
Alderdice F, Lynn F, Lobel M. A review and psychometric evaluation of pregnancy-specific stress measures. J Psychosom Obstet Gynaecol. 2012;33:62–77.CrossRefPubMed
42.
Green JM, Kafetsios K. Positive experiences of early motherhood: Predictive variables from a longitudinal study. J Reprod Infant Psychol. 1997;15:141–57.CrossRef
43.
Green JM, Snowdon C, Statham H. Pregnant women's attitudes to abortion and prenatal screening. J Reprod Infant Psychol. 1993;11:31–9.CrossRef
44.
Green JM, Statham H, Snowdon C. Women's knowledge of prenatal screening tests. 1: Relationships with hospital screening policy and demographic factors. J Reprod Infant Psychol. 1993;11:11–20.CrossRef
45.
Statham H, Green JM. The effects of miscarriage and other ‘unsuccessful’pregnancies on feelings early in a subsequent pregnancy. J Reprod Infant Psychol. 1994;12:45–54.CrossRef
46.
Statham H, Green JM, Kafetsios K. Who worries that something might be wrong with the baby? A prospective study of 1072 pregnant women. Birth. 1997;24:223–33.CrossRefPubMed
47.
Green JM, Kafetsios K, Statham HE, Snowdon CM. Factor structure, validity and reliability of the Cambridge Worry Scale in a pregnant population. J Health Psychol. 2003;8:753–64.CrossRefPubMed
48.
De Ridder D, Schreurs K. Coping, social support and chronic disease: a research agenda. Psychol Health Med. 1996;1:71–82.CrossRef
49.
De Ridder DT, Schreurs KM, Bensing JM. Adaptive Tasks, Coping and Quality of Life of Chronically Ill Patients The Cases of Parkinson's Disease and Chronic Fatigue Syndrome. J Health Psychol. 1998;3:87–101.CrossRefPubMed
50.
Savelkoul M, Post M, De Witte L, Van Den Borne H. Social support, coping and subjective well-being in patients with rheumatic diseases. Patient Educ Couns. 2000;39:205–18.CrossRefPubMed
51.
Hamilton JG, Lobel M. Types, patterns, and predictors of coping with stress during pregnancy: Examination of the Revised Prenatal Coping Inventory in a diverse sample. J Psychosom Obstet Gynaecol. 2008;29:97–104.CrossRefPubMed
52.
van Sonderen E. Sociale Steun Lijst–Interacties (SSL-I) en Sociale Steun Lijst-Discrepanties (SSL-D). Groningen: Noorderlijk Centrum voor Gezondheidsvraagstukken; 1993.
53.
Bridges KR, Sanderman R, van Sonderen E. An English language version of the social support list: preliminary reliability. Psychol Rep. 2002;90:1055–8.CrossRefPubMed
54.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782–6.CrossRefPubMed
55.
Reece SM. The Parent Expectations Survey A Measure of Perceived Self-Efficacy. Clin Nurs Res. 1992;1:336–46.CrossRefPubMed
56.
Littlefield V, Adams B. Patient participation in alternative perinatal care: impact on satisfaction and health locus of control. Res Nurs Health. 1987;10:139–48.CrossRefPubMed
57.
Littlefield VM, Chang A, Adams BN. Participation in alternative care: Relationship to anxiety, depression, and hostility. Res Nurs Health. 1990;13:17–25.CrossRefPubMed
58.
Novick G, Reid AE, Lewis J, Kershaw TS, Rising SS, Ickovics JR. Group prenatal care: model fidelity and outcomes. Am J Obstet Gynecol. 2013;209:112. e1-6.CrossRefPubMedPubMedCentral
59.
Geerts CC, Klomp T, Lagro-Janssen AL, Twisk JW, Van Dillen J, De Jonge A. Birth setting, transfer and maternal sense of control: results from the DELIVER study. BMC Pregnancy Childbirth. 2014;14:1.CrossRef
60.
Kempen G, Van Eijk L. The psychometric properties of the SSL12-I, a short scale for measuring social support in the elderly. Soc Indic Res. 1995;35:303–12.CrossRef
61.
Murray D, Cox JL. Screening for depression during pregnancy with the Edinburgh Depression Scale (EDDS). J Reprod Infant Psychol. 1990;8:99–107.CrossRef
62.
Green J, Murray D. The use of the Edinburgh Postnatal Depression Scale in research to explore the relationship between antenatal and postnatal dysphoria. Perinatal psychiatry: use and misuse of the Edinburgh postnatal depression scale Gaskell, London. 1994:180–198.
63.
Adouard F, Glangeaud-Freudenthal N, Golse B. Validation of the Edinburgh postnatal depression scale (EPDS) in a sample of women with high-risk pregnancies in France. Arch Womens Ment Health. 2005;8:89–95.CrossRefPubMed
64.
Reece SM, Harkless G. Self-efficacy, stress, and parental adaptation: Applications to the care of childbearing families. J Fam Nurs. 1998;4:198–215.CrossRef
65.
McCarter‐Spaulding DE, Kearney MH. Parenting Self Efficacy and Perception of Insufficient Breast Milk. J Obstet Gynecol Neonatal Nurs. 2001;30:515–22.CrossRefPubMed
Metadata
Title
Group based prenatal care in a low-and high risk population in the Netherlands: a study protocol for a stepped wedge cluster randomized controlled trial
Authors
Birgit S. van Zwicht
Matty R. Crone
Jan M. M. van Lith
Marlies E. B. Rijnders
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2016
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-016-1152-0

Other articles of this Issue 1/2016

BMC Pregnancy and Childbirth 1/2016 Go to the issue

Research article

Pre-pregnancy obesity and non-adherence to multivitamin use: findings from the National Pregnancy Risk Assessment Monitoring System (2009–2011)

Research article

Advice given by community members to pregnant women: a mixed methods study

Research article

The prevalence of women’s emotional and physical health problems following a postpartum haemorrhage: a systematic review

Study protocol

Normal ranges for fetal electrocardiogram values for the healthy fetus of 18–24 weeks of gestation: a prospective cohort study

Research article

Fetal membrane imaging and the prediction of preterm birth: a systematic review, current issues, and future directions

Research article

Medication utilization pattern for management of pregnancy complications: a study in Western Nepal