What are the recommended clinical assessment and screening tests during pregnancy?

621 Pages·2015·4.53 MB·English

KCE REPORT 248S
WHAT ARE THE RECOMMENDED CLINICAL ASSESSMENT AND
SCREENING TESTS DURING PREGNANCY?
APPENDIX
2015 www.kce.fgov.be

KCE REPORT 248S
GOOD CLINICAL PRACTICE
WHAT ARE THE RECOMMENDED CLINICAL ASSESSMENT AND
SCREENING TESTS DURING PREGNANCY?
APPENDIX

WILFRIED GYSELAERS, PASCALE JONCKHEER, NADERA AHMADZAI, MOHAMMED T. ANSARI, SERENA CARVILLE, KATHARINA DWORZYNSKI,
LAURA GAUDET, JESSICA GLEN, KATIE JONES, PAUL MILLER, JENNIFER MARIE TETZLAFF, SOPHIE ALEXANDER, KAREL ALLEGAERT, KATRIEN
BEECKMAN, GILLES CEYSENS, YOLANDE CHRISTIANE, NADINE DE RONNE, BÉNÉDICTE DE THYSEBAERT, NICOLE DEKKER, ALEXANDRA DENYS,
PATRICIA EECKELEERS, ANA HERNANDEZ, EVELYNE MATHIEU, LIEVE SEUNTJENS, LEEN VERLEYE, SABINE STORDEUR

2015 www.kce.fgov.be
COLOPHON
Title: What are the recommended clinical assessment and screening tests during pregnancy? – Appendix
Authors: Wilfried Gyselaers (Ziekenhuis Oost-Limburg Genk), Pascale Jonckheer (KCE), Nadera Ahmadzai (OHRI),
Mohammed T. Ansari (OHRI), Serena Carville (NCGC), Katharina Dworzynski (NCGC), Laura Gaudet (OHRI),
Jessica Glen (NCGC), Katie Jones (NCGC), Paul Miller (NCGC), Jennifer Marie Tetzlaff (OHRI), Sophie Alexander
(ULB), Karel Allegaert (UZ Leuven), Katrien Beeckman (UZ Brussel), Gilles Ceysens (ONE), Yolande Christiane
(gyneacologist Verviers), Nadine De Ronne (Kind en Gezin), Bénédicte de Thysebaert (UPSfB), Nicole Dekker
(Domus Medica), Alexandra Denys (Bolle Buik Vroedvrouwenteam), Patricia Eeckeleers (SSMG), Ana Hernandez
(UPSfB), Evelyne Mathieu (UPSfB), Lieve Seuntjens (Domus Medica), Leen Verleye (KCE), Sabine Stordeur
(KCE)
Project coordinator and Senior Sabine Stordeur (KCE)
supervisor:
Reviewers: Nadia Benahmed (KCE), Kirsten Holdt-Henningsen (KCE), Raf Mertens (KCE)
Stakeholders: Michèle Bertrand (CHU Brugmann – GIP), Isabel Callens (UVC Brugmann), Frédéric Chantraine (AbeFUM),
Walter Foulon (UZ Brussel), Leonardo Gucciardo (UZ Brussels – GIP), Liesbeth Lewi (VVOG), Anne Loccufier
(VVOG), Anne Niset (CFSF), Elizaveta Padalko (UZ Gent), Margriet Pluymaekers (Zwanger in Brussel –
VERREPT), Berlinde Tillie (CHU Brugmann – GIP), Ann-Sophie Van Parys (UZ Gent), Ruth Verbrugge (WIV –
ISP), Patrick Van Reempts (UZ Antwerpen)
External assessors: Rhona Hughes (NHS Lothian, Edinburgh, UK), Marc Spaanderman (Maastricht University Medical Centre, NL)
External validators: Jan Bosteels (CEBAM), Trudy Bekkering (CEBAM), Roland Van Dijck (H-H Leuven)
Acknowledgements: Endnote: Nicolas Fairon (KCE)
Synthesis: Karin Rondia (KCE), Gudrun Briat (KCE)
Chapter on diabetes: Pamela Gironi (Erasme), Paul Ramaekers (UZ Antwerpen), Katrien Benhalima (UZ Leuven),
Chantal Mathieu (UZ Leuven)
Chapter on hypothyroidism: Yves Jacquemin (UA), Rodrigo Moreno-Reyes (ULB)
Chapter on vitamin D deficiency: Yves Jacquemin (UA)
Chapter on CMV: Walter Foulon (UZ Brussel), Yves Jacquemin (UA)
Chapter on Toxoplasmosis: Walter Foulon (UZ Brussel), Yves Jacquemin (UA)
Chapter on risk factors: Françoise Mambourg (KCE)
OHRI Chapters: Becky Skidmore for Conducting literature search; Raymond Daniel for acquisition of articles, Misty
Pratt and Katrina Sullivan for screening, formatting, data extraction, risk of bias assessment; Rafat Islam for
screening, and help with GRADE; Dianna Wolfe for screening, data extraction, risk of bias assessment; Mona
Hersi for screening, and formatting; and Brian Younho Hong for screening.
Other reported interests: Membership of a stakeholder group on which the results of this report could have an impact: Liesbeth Lewi (VVOG
workgroup Verloskunde), Katrien Beeckman (VLOV)
Fees or other compensation for writing a publication or participating in its development: Lieve Seuntjes
(recommendation Domus Medica pregnancy follow-up), Nicole Dekker (co-author guideline pregnancy follow-up
Domus Medica)
Participation in scientific or experimental research as an initiator, principal investigator or researcher: Leonardo
Gucciardo (‘Place du pessaire d’Arabin chez la patiente à risque d’accouchement prématuré’), Frédéric Chantraine
(PI of site CHR Citadelle for the study ‘Prognosis in pre-eclampsia’ for Roche), Patrick Van Reempts (participation
in ‘Effective Perinatal Intensive Care in Europe’, European Study 7th European Framework – EPICE), Katrien
Beeckman (study ‘Prenataal zorggebruik in Brussel’, developing tool to mesure adequacy of care), Yves
Jacquemin (current research project on Vitamine D deficiency in developing pregnancy)
Grants, fees or funds for a member of staff or another form of compensation for the execution of research: Wilfried
Gyselaers (promotor PhD project Medicine and Biomedical sciences Universiteit Hasselt)
Payments to speak, training remuneration, subsidised travel or payment for participation at a conference: Katrien
Beeckman (member EUCOST network ISO907 optimizing childbirth across Europe), Yves Jacquemin (cursus for
CTG/ST AM)
Presidency or accountable function within an institution, association, department or other entity on which the results
of this report could have an impact: Frédéric Chantraine (president ABeFUM), Patrick Van Reempts (Head of
department Neonatology UZ Antwerpen), Katrien Beeckman (member VLOV, staff member management Nursing
UZ Brussel)
Layout: Ine Verhulst

Disclaimer: ● The external experts were consulted about a (preliminary) version of the scientific report. Their
comments were discussed during meetings. They did not co-author the scientific report and did not
necessarily agree with its content.
● Subsequently, a (final) version was submitted to the validators. The validation of the report results
from a consensus or a voting process between the validators. The validators did not co-author the
scientific report and did not necessarily all three agree with its content.
● Finally, this report has been approved by common assent by the Executive Board (see
http://kce.fgov.be/content/the-board).
● Only the KCE is responsible for errors or omissions that could persist. The policy recommendations
are also under the full responsibility of the KCE.

Publication date: 7 July 2015 (2nd edition; 1st edition: 30 June 2015)
Domain: Good Clinical Practice (GCP)
MeSH: Prenatal care; Prenatal diagnosis; Pregnancy
NLM Classification: WQ175
Language: English
Format: Adobe® PDF™ (A4)
Legal depot: D/2015/10.273/59

Copyright: KCE reports are published under a “by/nc/nd” Creative Commons Licence
http://kce.fgov.be/content/about-copyrights-for-kce-reports.

How to refer to this document? Gyselaers W, Jonckheer P, Ahmadzai N, Ansari MT, Carville S, Dworzynski K, Gaudet L, Glen J, Jones K, Miller
P, Tetzlaff J M, Alexander S, Allegaert K, Beeckman K, Ceysens G, Christiane Y, De Ronne N, de Thysebaert B,
Dekker N, Denys A, Eeckeleers P, Hernandez A, Mathieu E, Seuntjens L, Verleye L, Stordeur S. What are the
recommended clinical assessment and screening tests during pregnancy? – Appendix. Good Clinical Practice
(GCP) Brussels: Belgian Health Care Knowledge Centre (KCE). 2015. KCE Reports 248S. D/2015/10.273/59.
This document is available on the website of the Belgian Health Care Knowledge Centre.
KCE Report 248S Assessment and screening during pregnancy 1

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TABLE OF CONTENTS
LIST OF FIGURES .............................................................................................................................................. 7

LIST OF TABLES .............................................................................................................................................. 12
1. COMPOSITION OF EXPERTS AND STAKEHOLDERS GROUPS ................................................... 24
1.1. COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP ...................................................... 24
1.2. COMPOSITION OF THE STAKEHOLDERS GROUP ........................................................................ 25
1.3. COMPOSITION OF THE KCE EXPERT TEAM .................................................................................. 25
1.4. EXTERNAL RESEARCHERS INVOLVED IN THE GUIDELINE DEVELOPMENT ............................ 26
2. TOPICS PROPOSED BY THE GDG .................................................................................................. 27
3. RISK FACTORS THAT MAY IMPLY ADDITIONAL CARE ............................................................... 29
4. PATHWAYS FOR SCREENING OF CMV, TOXOPLASMOSIS AND GESTATIONAL DIABETES . 32
4.1. CYTOMEGALOVIRUS ........................................................................................................................ 32
4.2. TOXOPLASMOSIS .............................................................................................................................. 33
4.3. GESTATIONAL DIABETES ................................................................................................................. 34
5. P.I.C.O. FOR FULL SEARCH QUESTIONS ...................................................................................... 37
5.1. CYTOMEGALOVIRUS ........................................................................................................................ 37
5.2. TOXOPLASMOSIS .............................................................................................................................. 39
5.3. CHLAMYDIA TRACHOMATIS ............................................................................................................ 41
5.4. GROUP B STREPTOCOCCUS .......................................................................................................... 42
5.5. GESTATIONAL DIABETES ................................................................................................................. 43
5.6. HYPOTHYROIDISM ............................................................................................................................ 45
5.7. VITAMIN D DEFICIENCY .................................................................................................................... 47
5.8. RISK OF PRETERM BIRTH ................................................................................................................ 48
5.9. RISK OF PREECLAMPSIA ................................................................................................................. 51
5.10. SURVEILLANCE OF PREGNANCIES THAT PASSED THEIR DUE DATE ...................................... 52
6. SEARCH STRATEGIES ..................................................................................................................... 54
6.1. SEARCH STRATEGY FOR GUIDELINES .......................................................................................... 54
2 Assessment and screening during pregnancy KCE Report 248S

6.2. SEARCH STRATEGIES FOR OTHER PUBLICATIONS (SYSTEMATIC REVIEWS, META-
ANALYSES, INDIVIDUAL STUDIES) FOR FULL SEARCH QUESTIONS ........................................ 55
6.2.1. Cytomegalovirus ................................................................................................................... 55
6.2.2. Toxoplasmosis ...................................................................................................................... 60
6.2.3. Chlamydia trachomatis .......................................................................................................... 64
6.2.4. Group B streptococcus .......................................................................................................... 69
6.2.5. Gestational diabetes ............................................................................................................. 73
6.2.6. Hypothyroidism ..................................................................................................................... 78
6.2.7. Vitamin D deficiency ............................................................................................................ 110
6.2.8. Risk of preterm birth ............................................................................................................ 128
6.2.9. Risk of preeclampsia ........................................................................................................... 179
6.2.10. Pregnancies that passed their due date ............................................................................. 200
7. STUDY SELECTION ......................................................................................................................... 221
7.1. STUDY SELECTION FOR FULL SEARCH QUESTIONS ................................................................ 221
7.1.1. Cytomegalovirus ................................................................................................................. 221
7.1.2. Toxoplasmosis .................................................................................................................... 222
7.1.3. Chlamydia trachomatis ........................................................................................................ 223
7.1.4. Group B streptococcus ........................................................................................................ 224
7.1.5. Gestational diabetes ........................................................................................................... 225
7.1.6. Hypothyroidism ................................................................................................................... 227
7.1.7. Vitamin D deficiency ............................................................................................................ 229
7.1.8. Risk of preeclampsia ........................................................................................................... 233
7.1.9. Pregnancies that passed their due date ............................................................................. 234
8. QUALITY APPRAISAL ..................................................................................................................... 235
8.1. QUALITY APPRAISAL TOOLS ......................................................................................................... 235
8.1.1. Guidelines ........................................................................................................................... 235
8.1.2. Systematic reviews ............................................................................................................. 236
8.1.3. RCTs ................................................................................................................................... 238
8.1.4. Observational studies .......................................................................................................... 240
8.1.5. Diagnostic accuracy studies ................................................................................................ 241
KCE Report 248S Assessment and screening during pregnancy 3

8.2. QUALITY APPRAISAL OF GUIDELINES ......................................................................................... 244
8.3. QUALITY APPRAISAL FOR FULL SEARCH QUESTIONS ............................................................. 245
8.3.1. Cytomegalovirus ................................................................................................................. 245
8.3.2. Toxoplasmosis .................................................................................................................... 247
8.3.3. Chlamydia trachomatis ........................................................................................................ 251
8.3.4. Group B streptococcus ........................................................................................................ 252
8.3.5. Gestational diabetes ........................................................................................................... 259
8.3.6. Hypothyroidism ................................................................................................................... 268
8.3.7. Vitamin D deficiency ............................................................................................................ 278
8.3.8. Risk of preterm birth ............................................................................................................ 296
8.3.9. Risk of preeclampsia ........................................................................................................... 308
8.3.10. Pregnancies that passed their due date ............................................................................. 308
9. EVIDENCE TABLES ......................................................................................................................... 315
9.1. CYTOMEGALOVIRUS ...................................................................................................................... 315
9.2. TOXOPLASMOSIS ............................................................................................................................ 317
9.2.1. Screening for toxoplamosis ................................................................................................. 317
9.2.2. Lifestyle advice for toxoplasmosis ...................................................................................... 325
9.3. CHLAMYDIA TRACHOMATIS .......................................................................................................... 329
9.4. GROUP B STREPTOCOCCUS ........................................................................................................ 333
9.5. GESTATIONAL DIABETES ............................................................................................................... 358
9.5.1. Universal screening vs. selected screening of gestational diabetes ................................... 358
9.5.2. Early risk-factor vs. late non-risk factor screening.of gestational diabetes ......................... 362
9.5.3. Different screening tests comparison.for gestational diabetes ........................................... 367
9.5.4. Diagnostic accuracy ............................................................................................................ 370
9.6. HYPOTHYROIDISM .......................................................................................................................... 377
9.6.1. Screening for hypothyroidism in asymptomatic pregnancies .............................................. 377
9.6.2. Therapy for subclinical hypothyroidism during pregnancy .................................................. 381
9.7. VITAMIN D DEFICIENCY .................................................................................................................. 389
9.7.1. Vitamin D supplementation during pregnancy .................................................................... 389
4 Assessment and screening during pregnancy KCE Report 248S

9.8. RISK OF PRETERM BIRTH .............................................................................................................. 417
9.8.1. Screening for preterm birth risk ........................................................................................... 417
9.8.2. Progesterone ....................................................................................................................... 419
9.8.3. Cerclage .............................................................................................................................. 435
9.8.4. Reduced physical activity .................................................................................................... 443
9.9. PREGNANCIES THAT PASSED THEIR DUE DATE ....................................................................... 446
10. SUMMARY OF FINDINGS TABLES AND GRADE PROFILES ...................................................... 461
10.1. CYTOMEGALOVIRUS ...................................................................................................................... 461
10.1.1. Lifestyle advice for CMV infection ....................................................................................... 461
10.2. TOXOPLASMOSIS ............................................................................................................................ 462
10.2.1. Screening for toxoplasmosis infection ................................................................................ 462
10.2.2. Lifestyle advice for toxoplamosis infection .......................................................................... 466
10.3. CHLAMYDIA TRACHOMATIS .......................................................................................................... 468
10.4. GROUP B STREPTOCOCCUS ........................................................................................................ 470
10.5. GESTATIONAL DIABETES ............................................................................................................... 472
10.5.1. Universal screening vs. selected screening ........................................................................ 472
10.5.2. Early risk-factor vs. late non-risk factor screening.of gestational diabetes ......................... 474
10.5.3. Different screening tests comparison.for gestational diabetes ........................................... 476
10.5.4. Diagnostic accuracy ............................................................................................................ 479
10.6. HYPOTHYROISDISM ....................................................................................................................... 481
10.6.1. Screening for hypothyroidism .............................................................................................. 481
10.6.2. Therapy for subclinical hypothyroidism ............................................................................... 484
10.7. VITAMIN D DEFICIENCY .................................................................................................................. 487
10.7.1. Vitamin D supplementation vs. no vitamin D supplementation ........................................... 487
10.7.2. Vitamin D + calcium vs. no vitamin D/calcium supplementation ......................................... 491
10.8. RISK OF PRETERM BIRTH .............................................................................................................. 492
10.8.1. Screening by repeat digital vaginal exam versus no screening .......................................... 492
10.8.2. Progesterone vs no progesterone to prevent preterm birth ................................................ 493
10.8.3. Cerclage vs no cerclage to prevent preterm birth ............................................................... 495