How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine?

M. Braakhekke, E. I. Kamphuis, M. M. Van Rumste, F. Mol, F. Van Der Veen, B. W. Mol

Research output: Contribution to journalReview article

13 Citations (Scopus)

Abstract

STUDY QUESTION How do randomised controlled trials (RCTs) in reproductive medicine report maternal and neonatal outcomes, specifically singleton live birth? SUMMARY ANSWER Despite the widespread appeal to use singleton live birth as the outcome measure in subfertility trials, 80% of RCTs fail to do so, and fail to report on neonatal and maternal outcomes. WHAT IS KNOWN ALREADY The aim of reproductive medicine is to assist subfertile couples in their wish to have children. A decade ago it was proposed to use singleton live birth as the outcome measure. We assessed whether clinical research has followed this recommendation, and how neonatal/maternal outcomes are reported. STUDY DESIGN, SIZE, DURATION A review of the published literature from 1 January 1966 to 31 December 2012 was performed using the Cochrane database. We compared the time periods before and after 2004; the year after ESHRE recommended the use of singleton live birth. PARTICIPANTS/MATERIALS, SETTING, METHODS We searched the Cochrane database for RCTs in reproductive medicine, and recorded the number of studies that used singleton live birth as the outcome measure. We also recorded the reporting neonatal and maternal outcomes. MAIN RESULTS AND THE ROLE OF CHANCE We identified 910 RCTs that reported on fertility treatments, of which 182 RCTs (20%) reported on singleton live birth [before 2004 96/518 (19%); after 2003 86/392 RCTs (22%)]. Singleton live birth was the primary outcome in 68 RCTs (7.4%). Only 44 RCTs (4.8%) reported on neonatal outcome, while 52 RCTs (5.7%) reported on maternal outcome. LIMITATIONS, REASONS FOR CAUTION We only included Cochrane reviews, thus report here only on the higher quality studies. The actual reporting on maternal and neonatal outcome may even be lower when studies of lower quality are included. WIDER IMPLICATIONS OF THE FINDINGS Although a decade ago singleton live birth was recommended as the outcome measure of reproductive medicine research, this has not been followed; currently most clinical research in reproductive medicine does not report beyond the occurrence of pregnancy.

LanguageEnglish
Pages1211-1217
Number of pages7
JournalHuman Reproduction
Volume29
Issue number6
DOIs
Publication statusPublished - 1 Jan 2014

Keywords

  • Live birth
  • Maternal outcome
  • Neonatal outcome
  • Outcome measure
  • Reproductive medicine

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

Cite this

Braakhekke, M., Kamphuis, E. I., Van Rumste, M. M., Mol, F., Van Der Veen, F., & Mol, B. W. (2014). How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine? Human Reproduction, 29(6), 1211-1217. https://doi.org/10.1093/humrep/deu069
Braakhekke, M. ; Kamphuis, E. I. ; Van Rumste, M. M. ; Mol, F. ; Van Der Veen, F. ; Mol, B. W. / How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine?. In: Human Reproduction. 2014 ; Vol. 29, No. 6. pp. 1211-1217.
@article{910b45bfe40f4e65b0f88293a6cea2dc,
title = "How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine?",
abstract = "STUDY QUESTION How do randomised controlled trials (RCTs) in reproductive medicine report maternal and neonatal outcomes, specifically singleton live birth? SUMMARY ANSWER Despite the widespread appeal to use singleton live birth as the outcome measure in subfertility trials, 80{\%} of RCTs fail to do so, and fail to report on neonatal and maternal outcomes. WHAT IS KNOWN ALREADY The aim of reproductive medicine is to assist subfertile couples in their wish to have children. A decade ago it was proposed to use singleton live birth as the outcome measure. We assessed whether clinical research has followed this recommendation, and how neonatal/maternal outcomes are reported. STUDY DESIGN, SIZE, DURATION A review of the published literature from 1 January 1966 to 31 December 2012 was performed using the Cochrane database. We compared the time periods before and after 2004; the year after ESHRE recommended the use of singleton live birth. PARTICIPANTS/MATERIALS, SETTING, METHODS We searched the Cochrane database for RCTs in reproductive medicine, and recorded the number of studies that used singleton live birth as the outcome measure. We also recorded the reporting neonatal and maternal outcomes. MAIN RESULTS AND THE ROLE OF CHANCE We identified 910 RCTs that reported on fertility treatments, of which 182 RCTs (20{\%}) reported on singleton live birth [before 2004 96/518 (19{\%}); after 2003 86/392 RCTs (22{\%})]. Singleton live birth was the primary outcome in 68 RCTs (7.4{\%}). Only 44 RCTs (4.8{\%}) reported on neonatal outcome, while 52 RCTs (5.7{\%}) reported on maternal outcome. LIMITATIONS, REASONS FOR CAUTION We only included Cochrane reviews, thus report here only on the higher quality studies. The actual reporting on maternal and neonatal outcome may even be lower when studies of lower quality are included. WIDER IMPLICATIONS OF THE FINDINGS Although a decade ago singleton live birth was recommended as the outcome measure of reproductive medicine research, this has not been followed; currently most clinical research in reproductive medicine does not report beyond the occurrence of pregnancy.",
keywords = "Live birth, Maternal outcome, Neonatal outcome, Outcome measure, Reproductive medicine",
author = "M. Braakhekke and Kamphuis, {E. I.} and {Van Rumste}, {M. M.} and F. Mol and {Van Der Veen}, F. and Mol, {B. W.}",
year = "2014",
month = "1",
day = "1",
doi = "10.1093/humrep/deu069",
language = "English",
volume = "29",
pages = "1211--1217",
journal = "Human Reproduction",
issn = "0268-1161",
publisher = "Oxford University Press",
number = "6",

}

Braakhekke, M, Kamphuis, EI, Van Rumste, MM, Mol, F, Van Der Veen, F & Mol, BW 2014, 'How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine?', Human Reproduction, vol. 29, no. 6, pp. 1211-1217. https://doi.org/10.1093/humrep/deu069

How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine? / Braakhekke, M.; Kamphuis, E. I.; Van Rumste, M. M.; Mol, F.; Van Der Veen, F.; Mol, B. W.

In: Human Reproduction, Vol. 29, No. 6, 01.01.2014, p. 1211-1217.

Research output: Contribution to journalReview article

TY - JOUR

T1 - How are neonatal and maternal outcomes reported in randomised controlled trials (RCTs) in reproductive medicine?

AU - Braakhekke, M.

AU - Kamphuis, E. I.

AU - Van Rumste, M. M.

AU - Mol, F.

AU - Van Der Veen, F.

AU - Mol, B. W.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - STUDY QUESTION How do randomised controlled trials (RCTs) in reproductive medicine report maternal and neonatal outcomes, specifically singleton live birth? SUMMARY ANSWER Despite the widespread appeal to use singleton live birth as the outcome measure in subfertility trials, 80% of RCTs fail to do so, and fail to report on neonatal and maternal outcomes. WHAT IS KNOWN ALREADY The aim of reproductive medicine is to assist subfertile couples in their wish to have children. A decade ago it was proposed to use singleton live birth as the outcome measure. We assessed whether clinical research has followed this recommendation, and how neonatal/maternal outcomes are reported. STUDY DESIGN, SIZE, DURATION A review of the published literature from 1 January 1966 to 31 December 2012 was performed using the Cochrane database. We compared the time periods before and after 2004; the year after ESHRE recommended the use of singleton live birth. PARTICIPANTS/MATERIALS, SETTING, METHODS We searched the Cochrane database for RCTs in reproductive medicine, and recorded the number of studies that used singleton live birth as the outcome measure. We also recorded the reporting neonatal and maternal outcomes. MAIN RESULTS AND THE ROLE OF CHANCE We identified 910 RCTs that reported on fertility treatments, of which 182 RCTs (20%) reported on singleton live birth [before 2004 96/518 (19%); after 2003 86/392 RCTs (22%)]. Singleton live birth was the primary outcome in 68 RCTs (7.4%). Only 44 RCTs (4.8%) reported on neonatal outcome, while 52 RCTs (5.7%) reported on maternal outcome. LIMITATIONS, REASONS FOR CAUTION We only included Cochrane reviews, thus report here only on the higher quality studies. The actual reporting on maternal and neonatal outcome may even be lower when studies of lower quality are included. WIDER IMPLICATIONS OF THE FINDINGS Although a decade ago singleton live birth was recommended as the outcome measure of reproductive medicine research, this has not been followed; currently most clinical research in reproductive medicine does not report beyond the occurrence of pregnancy.

AB - STUDY QUESTION How do randomised controlled trials (RCTs) in reproductive medicine report maternal and neonatal outcomes, specifically singleton live birth? SUMMARY ANSWER Despite the widespread appeal to use singleton live birth as the outcome measure in subfertility trials, 80% of RCTs fail to do so, and fail to report on neonatal and maternal outcomes. WHAT IS KNOWN ALREADY The aim of reproductive medicine is to assist subfertile couples in their wish to have children. A decade ago it was proposed to use singleton live birth as the outcome measure. We assessed whether clinical research has followed this recommendation, and how neonatal/maternal outcomes are reported. STUDY DESIGN, SIZE, DURATION A review of the published literature from 1 January 1966 to 31 December 2012 was performed using the Cochrane database. We compared the time periods before and after 2004; the year after ESHRE recommended the use of singleton live birth. PARTICIPANTS/MATERIALS, SETTING, METHODS We searched the Cochrane database for RCTs in reproductive medicine, and recorded the number of studies that used singleton live birth as the outcome measure. We also recorded the reporting neonatal and maternal outcomes. MAIN RESULTS AND THE ROLE OF CHANCE We identified 910 RCTs that reported on fertility treatments, of which 182 RCTs (20%) reported on singleton live birth [before 2004 96/518 (19%); after 2003 86/392 RCTs (22%)]. Singleton live birth was the primary outcome in 68 RCTs (7.4%). Only 44 RCTs (4.8%) reported on neonatal outcome, while 52 RCTs (5.7%) reported on maternal outcome. LIMITATIONS, REASONS FOR CAUTION We only included Cochrane reviews, thus report here only on the higher quality studies. The actual reporting on maternal and neonatal outcome may even be lower when studies of lower quality are included. WIDER IMPLICATIONS OF THE FINDINGS Although a decade ago singleton live birth was recommended as the outcome measure of reproductive medicine research, this has not been followed; currently most clinical research in reproductive medicine does not report beyond the occurrence of pregnancy.

KW - Live birth

KW - Maternal outcome

KW - Neonatal outcome

KW - Outcome measure

KW - Reproductive medicine

UR - http://www.scopus.com/inward/record.url?scp=84900810144&partnerID=8YFLogxK

U2 - 10.1093/humrep/deu069

DO - 10.1093/humrep/deu069

M3 - Review article

VL - 29

SP - 1211

EP - 1217

JO - Human Reproduction

T2 - Human Reproduction

JF - Human Reproduction

SN - 0268-1161

IS - 6

ER -