• Using the vaginal progesterone in prophylaxis of preterm birth: if there are benefits? 

Using the vaginal progesterone in prophylaxis of preterm birth: if there are benefits? 

HEALTH OF WOMAN. 2016.4(110):28–36; doi 10.15574/HW.2016.110.28 
 

Using the vaginal progesterone in prophylaxis of preterm birth: if there are benefits? 
 

Mogilevkina I., Gurianov V.

National Medical Academy of Postgraduate Education P. L. Shupyk, Kiev

A.A. Bogomolets National Medical University, Kiev 
 

The objective: to conduct data and conclusions analysis provided by the investigators of OPPTIMUM Study in terms of compliance to ethical principles and principles of biostatistics.


Patients and methods. Рublished data by NormanJ. et al., Vaginal progesterone prophylaxis for preterm birth (OPPTIMUM): a multicenter, randomized, double-blind trial//Lancet. 2016; on-line calculator: https://www.sealedenvelope.com/power/binary-superiority; Gpower and MedCalc v.16.4.1. software.


Results. OPPTIMUM study has several problems which make the research outcomes and conclusions questionable. Usage of placebo during recent 2 years of the study in women with a cervix length Ј 25 mm (since the National protocols for medical care in this particular case has been changed) provokes an ethical question. From biostatistics point of view the study is associated with a low compliance (69%), which led to insufficient statistical power for evaluating obstetrics outcomes and effects of vaginal micronized progesterone in women with a short cervix.


Conclusion. The results of OPPTIMUM Study do not allow to make a conclusion that the efficacy of vaginal progesterone in improving outcomes in prevention of preterm birth in women with a singleton pregnancy and a short cervix is either non-existent or weak. FIGO recommendations from 2015 for usage of vaginal micronized progesterone for prophylaxis of preterm birth in women with a short cervix remain to be relevant because of no evidence to change them.


Key words: preterm birth, vaginal micronized progesterone.

 

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