PMID- 29297356
OWN - NLM
STAT- MEDLINE
DCOM- 20180823
LR  - 20181113
IS  - 1742-4755 (Electronic)
IS  - 1742-4755 (Linking)
VI  - 14
IP  - Suppl 3
DP  - 2017 Dec 14
TI  - Should pregnant women be excluded from a community-based lifestyle intervention 
      trial? A case study.
PG  - 165
LID - 10.1186/s12978-017-0422-2 [doi]
LID - 165
AB  - Kerala, the southernmost Indian state, is known as the diabetes capital of the 
      country. A community-based lifestyle modification program was implemented in the 
      rural areas of Kerala, India, to assess effectiveness in reducing the incidence 
      of type 2 diabetes mellitus (T2DM) among individuals at high risk. High-risk 
      individuals for T2DM were identified through home screening and enrolled into the 
      program after an oral glucose tolerance test to rule out T2DM. Pregnant women 
      were excluded from participation in the trial without justification. An analysis 
      is offered to show that exclusion in this case compromised the ethical 
      requirements of fairness and favorable risk-benefit ratio: specifically, pregnant 
      women were deprived of the benefits of screening for high-risk status and 
      subsequent potential involvement in the lifestyle modification intervention, an 
      effective preventive strategy. Exclusion of pregnant women from translational and 
      implementation research with known benefits over risk violates several ethical 
      principles and further limits the exploration and advancement of research for 
      future disease prevention in the population at large. Clearer guidelines on 
      minimal risk and benefit need to be established in order to facilitate research 
      that is beneficial to pregnant women and the developing fetus.
FAU - Mathews, Elezebeth
AU  - Mathews E
AD  - Department of Public Health and Community Medicine, Central University of Kerala, 
      Kasaragod, Kerala, India. dr.elezebethmathews@cukerala.ac.in.
LA  - eng
PT  - Journal Article
DEP - 20171214
PL  - England
TA  - Reprod Health
JT  - Reproductive health
JID - 101224380
SB  - IM
MH  - Diabetes Mellitus, Type 2/*prevention & control
MH  - Diabetes, Gestational/prevention & control
MH  - Female
MH  - Glucose Tolerance Test
MH  - *Health Behavior
MH  - Health Services Accessibility
MH  - Humans
MH  - India
MH  - Patient Selection/*ethics
MH  - Pregnancy
MH  - Randomized Controlled Trials as Topic/*ethics
PMC - PMC5751519
OTO - NOTNLM
OT  - Clinical translational research
OT  - Ethics
OT  - Fair inclusion
OT  - Lifestyle modification
OT  - Pregnancy research
OT  - Type 2 diabetes mellitus
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Not applicable. CONSENT FOR 
      PUBLICATION: Not applicable. COMPETING INTERESTS: The author declares that she 
      has no competing interests. PUBLISHER'S NOTE: Springer Nature remains neutral 
      with regard to jurisdictional claims in published maps and institutional 
      affiliations.
EDAT- 2018/01/04 06:00
MHDA- 2018/08/24 06:00
PMCR- 2017/12/14
CRDT- 2018/01/04 06:00
PHST- 2018/01/04 06:00 [entrez]
PHST- 2018/01/04 06:00 [pubmed]
PHST- 2018/08/24 06:00 [medline]
PHST- 2017/12/14 00:00 [pmc-release]
AID - 10.1186/s12978-017-0422-2 [pii]
AID - 422 [pii]
AID - 10.1186/s12978-017-0422-2 [doi]
PST - epublish
SO  - Reprod Health. 2017 Dec 14;14(Suppl 3):165. doi: 10.1186/s12978-017-0422-2.