Am J Perinatol 2009; 26(1): 069-080
DOI: 10.1055/s-0028-1095178
© Thieme Medical Publishers

Randomized Clinical Trials behind Level A Recommendations in Obstetric Practice Bulletins: Compliance with CONSORT Statement

Suneet P. Chauhan1 , Vincenzo Berghella2 , Maureen Sanderson3 , Danish Siddiqui1 , Nancy W. Hendrix2 , Everett F. Magann1
  • 1Aurora Health Care, West Allis, Wisconsin
  • 2Thomas Jefferson University, Philadelphia, Pennsylvania
  • 3University of Texas School of Public Health at Brownsville, Brownsville, Texas
Further Information

Publication History

Publication Date:
31 October 2008 (online)

ABSTRACT

We appraised the compliance of randomized clinical trials (RCTs) cited for level A recommendations in obstetric practice bulletins (OPBs) and published after the CONSORT (Consolidated Standards of Reporting Trials, published 1996) statement. From the CONSORT checklist, we identified 50 separate items the RCTs should describe in the article and assigned 1 point if present; 0, if absent. The CONSORT score was the total points, expressed as a percentage. From 1998 to 2006, American College of Obstetricians and Gynecologists published 68 level A obstetric recommendations, and 20 (29%) are supported by ≥ 1 RCT published after 1997. The median CONSORT score for the 32 RCTs published after the statement was 73% (range 30 to 100%). Only four RCTs complied with 90% of the CONSORT statement. RCTs supporting level A recommendations in OPB have variable compliance with CONSORT. Recommendations that lack quality RCTs should prompt further studies into the topic.

REFERENCES

  • 1 Chauhan S P, Berghella V, Sanderson M, Magann E F, Morrison J C. American College of Obstetricians and Gynecologists practice bulletins: an Overview.  Am J Obstet Gynecol. 2006;  194 1564-1572
  • 2 American College of Obstetricians and Gynecologists .Reading the Medical Literature: Applying Evidence to Practice. Washington DC; ACOG 1998
  • 3 Schulz K F, Chalmers I, Grimes D A, Altman D G. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals.  JAMA. 1994;  272 125-128
  • 4 Begg C, Cho M, Eastwood S et al.. Improving the quality of reporting of randomized controlled trials. The CONSORT statement.  JAMA. 1996;  276 637-639
  • 5 Moher D, Jones A, Lepage L. CONSORT Group . (Consolidated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.  JAMA. 2001;  285 1992-1995
  • 6 Shea B, Boers M, Grimshaw J M, Hamel C, Bouter L M. Does updating improve the methodological and reporting quality of systematic reviews?.  BMC Med Res Methodol. 2006;  6 27-34
  • 7 American College of Obstetricians and Gynecologists .Premature Rupture of Membranes. ACOG Practice Bulletin No. 1. Washington DC; ACOG 1998
  • 8 American College of Obstetricians and Gynecologists .Prevention of Rh D Alloimmunization. ACOG Practice Bulletin No. 4. Washington DC; ACOG 1999
  • 9 American College of Obstetricians and Gynecologists .Thrombocytopenia in Pregnancy. ACOG Practice Bulletin No. 6. Washington DC; ACOG 1999
  • 10 American College of Obstetricians and Gynecologists .Management of Herpes in Pregnancy. ACOG Practice Bulletin No. 8. Washington DC; ACOG 1999
  • 11 American College of Obstetricians and Gynecologists .Antepartum Fetal Surveillance. ACOG Practice Bulletin No. 9. Washington DC; ACOG 1999
  • 12 American College of Obstetricians and Gynecologists .Induction of Labor. ACOG Practice Bulletin No. 10. Washington DC; ACOG 1999
  • 13 American College of Obstetricians and Gynecologists .Intrauterine Growth Restriction. ACOG Practice Bulletin No. 12. Washington DC; ACOG 2000
  • 14 American College of Obstetricians and Gynecologists .External Cephalic Version. ACOG Practice Bulletin No. 13. Washington DC; ACOG 2000
  • 15 American College of Obstetricians and Gynecologists .Operative Vaginal Delivery. ACOG Practice Bulletin No. 17. Washington DC; ACOG 2000
  • 16 American College of Obstetricians and Gynecologists .Thromboembolism in Pregnancy. ACOG Practice Bulletin No. 19. Washington DC; ACOG 2000
  • 17 American College of Obstetricians and Gynecologists .Perinatal Viral and Parasitic Infections. ACOG Practice Bulletin No. 20. Washington DC; ACOG 2000
  • 18 American College of Obstetricians and Gynecologists .Fetal Macrosomia. ACOG Practice Bulletin No. 22. Washington DC; ACOG 2000
  • 19 American College of Obstetricians and Gynecologists .Management of Recurrent Early Pregnancy Loss. ACOG Practice Bulletin No. 24. Washington DC; ACOG 2001
  • 20 American College of Obstetricians and Gynecologists .Prenatal Diagnosis of Fetal Chromosomal Abnormalities. ACOG Practice Bulletin No. 27. Washington DC; ACOG 2001
  • 21 American College of Obstetricians and Gynecologists .Chronic Hypertension in Pregnancy. ACOG Practice Bulletin No. 29. Washington DC; ACOG 2001
  • 22 American College of Obstetricians and Gynecologists .Gestational Diabetes. ACOG Practice Bulletin No. 30. Washington DC; ACOG 2001
  • 23 American College of Obstetricians and Gynecologists .Assessment of Risk Factors for Preterm Birth. ACOG Practice Bulletin No. 31. Washington DC; ACOG 2001
  • 24 American College of Obstetricians and Gynecologists .Diagnosis and Management of Preeclampsia and Eclampsia. ACOG Practice Bulletin No. 33. Washington DC; ACOG 2002
  • 25 American College of Obstetricians and Gynecologists .Obstetric Analgesia and Anesthesia. ACOG Practice Bulletin No. 36. Washington DC; ACOG 2002
  • 26 American College of Obstetricians and Gynecologists .Thyroid Disease in Pregnancy. ACOG Practice Bulletin No. 37. Washington DC; ACOG 2002
  • 27 American College of Obstetricians and Gynecologists .Perinatal Care at the Threshold of Viability. ACOG Practice Bulletin No. 38. Washington DC; ACOG 2002
  • 28 American College of Obstetricians and Gynecologists .Shoulder Dystocia. ACOG Practice Bulletin No. 40. Washington DC; ACOG 2002
  • 29 American College of Obstetricians and Gynecologists .Management of Preterm Labor. ACOG Practice Bulletin No. 43. Washington DC; ACOG 2003
  • 30 American College of Obstetricians and Gynecologists .Neural Tube Defects. ACOG Practice Bulletin No. 44. Washington DC; ACOG 2003
  • 31 American College of Obstetricians and Gynecologists .Prophylactic Antibiotics in Labor and Delivery. ACOG Practice Bulletin No. 47. Washington DC; ACOG 2003
  • 32 American College of Obstetricians and Gynecologists .Cervical Insufficiency. ACOG Practice Bulletin No. 48. Washington DC; ACOG 2003
  • 33 American College of Obstetricians and Gynecologists .Dystocia and Augmentation of Labor. ACOG Practice Bulletin No. 49. Washington DC; ACOG 2003
  • 34 American College of Obstetricians and Gynecologists .Nausea and Vomiting of Pregnancy. ACOG Practice Bulletin No. 52. Washington DC; ACOG 2004
  • 35 American College of Obstetricians and Gynecologists .Vaginal Birth after Previous Cesarean. ACOG Practice Bulletin No. 54. Washington DC; ACOG 2004
  • 36 American College of Obstetricians and Gynecologists .Management of Postterm Pregnancy. ACOG Practice Bulletin No. 55. Washington DC; ACOG 2004
  • 37 American College of Obstetricians and Gynecologists .Multiple Gestation: Complicated Twin, Triplet, and High-Order Multifetal Pregnancy. ACOG Practice Bulletin No. 56. Washington DC; ACOG 2004
  • 38 American College of Obstetricians and Gynecologists .Ultrasonography in Pregnancy. ACOG Practice Bulletin No. 58. Washington DC; ACOG 2004
  • 39 American College of Obstetricians and Gynecologists .Pregestational Diabetes Mellitus. ACOG Practice Bulletin No. 60. Washington DC; ACOG 2005
  • 40 American College of Obstetricians and Gynecologists .Hemoglobinopathies in Pregnancy. ACOG Practice Bulletin No. 64. Washington DC; ACOG 2005
  • 41 American College of Obstetricians and Gynecologists .Antiphospholipid Syndrome. ACOG Practice Bulletin No. 68. Washington DC; ACOG 2005
  • 42 American College of Obstetricians and Gynecologists .Intrapartum Fetal Heart Rate Monitoring. ACOG Practice Bulletin No. 70. Washington DC; ACOG 2005
  • 43 American College of Obstetricians and Gynecologists .Episiotomy. ACOG Practice Bulletin No. 71. Washington DC; ACOG 2006
  • 44 American College of Obstetricians and Gynecologists .Management of Alloimmunization during Pregnancy. ACOG Practice Bulletin No. 75. Washington DC; ACOG 2006
  • 45 American College of Obstetricians and Gynecologists .Postpartum Hemorrhage. ACOG Practice Bulletin No. 76. Washington DC; ACOG 2006
  • 46 Sanchez-Ramos L, Chen A H, Kaunitz A M, Gaudier F L, Delke I. Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study.  Obstet Gynecol. 1997;  89 909-912
  • 47 Mercer B M, Menachem M, Gary T et al.. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of membranes: a randomized control trial.  JAMA. 1997;  278 989-995
  • 48 Lovett S M, Weiss J D, Diogo M J, Williams P T, Garite T J. A prospective, double-blind, randomized, controlled clinical trial of ampicillin-sulbactam for preterm premature rupture of membranes in women receiving antenatal corticosteroid therapy.  Am J Obstet Gynecol. 1997;  176 1030-1038
  • 49 Buser D, Mora G, Arias F. A randomized comparison between misoprostol and dinoprostone for cervical ripening and labor induction in patients with unfavorable cervices.  Obstet Gynecol. 1997;  89 581-585
  • 50 Sanchez-Ramos L, Peterson D E, Delke I, Gaudier F L, Kaunitz A M. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial.  Obstet Gynecol. 1998;  91 401-405
  • 51 Srisomboon J, Piyamongkol W, Aiewsakul P. Comparison of intracervical and intravaginal misoprostol for cervical ripening and labour induction in patients with an unfavorable cervix.  J Med Assoc Thai. 1997;  80 189-194
  • 52 Magtibay P M, Ramin K D, Harris D Y, Ramsey P S, Ogburn Jr P L. Misoprostol as a labor induction agent.  J Matern Fetal Med. 1998;  7 15-18
  • 53 Golding J. A randomized trial of low dose aspirin for primiparae in pregnancy. The Jamaica Low Dose Aspirin Study Group.  Br J Obstet Gynaecol. 1998;  105 293-299
  • 54 Ober C, Karrison T, Odem R R et al.. Mononuclear-cell immunization in prevention of recurrent miscarriages: a randomized trial.  Lancet. 1999;  354 365-369
  • 55 Rai R, Cohen M, Dave M, Regan L. Randomized controlled trial of aspirin and aspirin plus heparin in pregnant women with recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies).  BMJ. 1997;  314 253-257
  • 56 The Canadian Early and Midtrimester Amniocentesis Trial (CEMAT) Group . Randomized trial to assess safety and fetal outcome of early and mid-trimester amniocentesis.  Lancet. 1998;  351 242-247
  • 57 Dyson D C, Danbe K H, Bamber J A et al.. Monitoring women at risk for preterm labor.  N Engl J Med. 1998;  338 15-19
  • 58 Brown H L, Britton K A, Brizendine E J et al.. A randomized comparison of home uterine activity monitoring in the outpatient management of women treated for preterm labor.  Am J Obstet Gynecol. 1999;  180 798-805
  • 59 Perino A, Vassiliadis A, Vucetich A et al.. Short-term therapy for recurrent abortion using intravenous immunoglobulins: results of double-blind placebo-controlled Italian study.  Hum Reprod. 1997;  12 2388-2392
  • 60 Stephenson M D, Dreher K, Houlihan E, Wu V. Prevention of unexplained recurrent spontaneous abortion using intravenous immunoglobulin: a prospective, randomized, double blinded, placebo-controlled trial.  Am J Reprod Immunol. 1998;  39 82-88
  • 61 Coetzee E J, Dommisse J, Anthon J. A randomized controlled trial of intravenous magnesium sulphate versus placebo in the management of women with severe pre-eclampsia.  Br J Obstet Gynaecol. 1998;  105 300-303
  • 62 Caritis S, Sibai B M, Hauth J et al.. Low-dose aspirin to prevent preeclampsia in women at high risk. National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units.  N Engl J Med. 1998;  338 701-705
  • 63 Goffinet F, Aboulker D, Paris-Llado J et al.. Screening with uterine Doppler in low risk pregnant women followed by low dose aspirin in abnormal results: a multicenter randomised controlled trial.  BJOG. 2001;  108 510-518
  • 64 Levine R J, Hauth J C, Curet L B et al.. Trail of calcium to prevent preeclampsia.  N Engl J Med. 1997;  337 69-76
  • 65 Crowther C A, Hiller J E, Pridmore B et al.. Calcium supplementation in nulliparous women for the prevention of pregnancy-induced hypertension, preeclampsia and preterm birth: an Australian randomized trial. FRACOG and the ACT Study Group.  Aust N Z J Obstet Gynaecol. 1999;  39 12-18
  • 66 Bofill J A, Vincent R D, Ross E L et al.. Nulliparous active labor, epidural analgesia, and cesarean delivery for dystocia.  Am J Obstet Gynecol. 1997;  177 1465-1470
  • 67 Sharma S K, Sidawi J E, Ramin S M, Lucas M J, Leveno K J, Cunningham F G. Cesarean delivery: a randomized trial of epidural versus patient-controlled meperidine analgesia during labor.  Anesthesiology. 1997;  87 487-494
  • 68 Jannet D, Abankwa A, Guyard B, Carbonne B, Marpeau L, Milliez J. Nicardipine versus salbutamol in the treatment of premature labor: A prospective randomized study.  Eur J Obstet Gynecol Reprod Biol. 1997;  73 11-16
  • 69 Koks C A, Brolmann H A, de Kleine M J, Manager P A. A randomized comparison of nifedipine and ritrodrine for suppression of preterm labor.  Eur J Obstet Gynecol Reprod Biol. 1998;  77 171-176
  • 70 Papatsonis D N, Van Geijn H P, Ader H J, Lange F M, Bleker O P, Decker G A. Nifedipine and ritrodrine in the management of preterm labor: a randomized multicenter trial.  Obstet Gynecol. 1997;  90 230-234
  • 71 Garcia-Velasco J A, Gonzalez Gonzalez A. A prospective randomized trial of nifedipine vs ritrodrine in threatened preterm labor.  Int J Gynaecol Obstet. 1998;  61 239-244
  • 72 Guinn D A, Goepfert A R, Owen J, Wenstrom K D, Hauth J C. Terbutaline pump maintenance therapy for prevention of preterm delivery: a double-blind trial.  Am J Obstet Gynecol. 1998;  179 874-878
  • 73 Gagnon A J, Waghorn K, Covell C. A randomized trial of one-to-one nurse support of woman in labor.  Birth. 1997;  24 71-77
  • 74 Bloom S L, McIntire D D, Kelly M A, Beimer H L, Burpo R H, Garcia M A, Leveno K J. Lack of effect of walking on labor and delivery.  N Engl J Med. 1998;  339 76-79
  • 75 Magann E F, Chauhan S P, Nevils B G, McNamara M F, Kinsella M J, Morrison J C. Management of pregnancies beyond forty-one weeks' gestation with an unfavorable cervix.  Am J Obstet Gynecol. 1998;  178 1279-1281
  • 76 Magann E F, Chauhan S P, McNamara M F, Bass J D, Estes C M, Morrison J C. Membrane sweeping versus dinoprostone vaginal insert in the management of pregnancies beyond 41 weeks with an unfavorable cervix.  J Perinatol. 1999;  19 88-91
  • 77 Wong S F, Hui S K, Choi H, Ho L C. Does sweeping of membranes beyond 40 weeks reduce the need for formal induction of labor?.  BJOG. 2002;  109 632-636
  • 78 Braman S S. Chronic cough due to acute bronchitis: ACCP evidence-based clinical practice guidelines.  Chest. 2006;  129 95S-103S
  • 79 Cough guidelines choke on evidence.  Lancet. 2006;  367 276
  • 80 Chauhan S P, Chang E, Brost B, Assel B, Baxter J, Grobman W A et al.. ACOG Practice Bulletins. Part III. Survey of Eleven Maternal-Fetal Medicine Specialists on Level B and C Recommendations in Obstetric. In press
  • 81 Stinson J N, McGrath P J, Yamada J T. Clinical trials in the Journal of Pediatric Psychology: applying the CONSORT statement.  J Pediatr Psychol. 2003;  28 159-167
  • 82 Balasubramanian S P, Wiener M, Alshameeri Z, Tiruvoipati R, Elbourne D, Reed M W. Standards of reporting of randomized controlled trials in general surgery: can we do better?.  Ann Surg. 2006;  244 663-667
  • 83 Djulbegovic B, Cantor A, Clarke M. The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.  Account Res. 2003;  10 301-315
  • 84 Faunce T A, Buckley N A. Of consents and CONSORTs: reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the “CONSORT” guidelines.  J Toxicol Clin Toxicol. 2003;  41 93-99

Suneet P ChauhanM.D. 

Aurora Health Care, 8901 W. Lincoln Ave

PAC West Allis, WI 53227

Email: suneet.chauhan@aurora.org