Serum progesterone levels and medical management of miscarriage
Research type
Research Study
Full title
Does serum progesterone levels influence the medical management of missed miscarriage?
IRAS ID
160201
Contact name
Anthony Tomlinson
Contact email
Sponsor organisation
Bolton NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Approximately 1 in 9 pregnancies end in spontaneous first trimester miscarriage. The various options available to the woman are expectant, medical and surgical management. The current NICE guideline recommends the use of misoprostol for management of miscarriage. This was based on the evidence showing studies where women received misoprostol only had good success rate. It currently does not recommend combined regime using mifepristone and misoprostol. This is based on lack of sufficient evidence. Currently there is one study that compares efficacy of misoprostol alone with combined regimen of mifepristone and misoprostol. The study showed women in the combined arm needed more intervention than misoprostol alone but it did not show any statistical significance. Hence they have concluded that as there is no statistical significance in combined mifepristone and misoprostol method versus the misoprostol, to use misoprostol alone as it will be cost effective to the NHS till further trials are in place.
Banerjee et. al 2013 had done a small observational study looking the level of progesterone and the outcome of the missed miscarriage. It was carried out in a group of 52 women in UK. The results showed that woman who did not respond to mifepristone and misoprostol regime had low levels of serum progestone. The study from the Banerjee et.al add another question to management of missed miscarriage. Do all women with miscarriage have same progesterone levels and hence does the same management fit all women? This study was based on the hypothesis that mifepristone acts as an agonist when there is low progesterone levels leading to delay expulsion of the products and failed medical management.
If our study can prove that low serum progesterone levels are associated with failed medical management with mifepristone and misoprostol, this may lead to individualised medical management to benefit the patient.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0020
Date of REC Opinion
12 May 2017
REC opinion
Further Information Favourable Opinion