Professional Documents
Culture Documents
2016
Gerhard et al, RCT Suppository 3/26 (12) 5/26 (19) 0.54 0.07 3.25
1987
Nyboe RCT Pellet inserted 18/153 (12) 22/150 0.78 0.37 1.59
Anderson et into gluteal (15)
al, 2002 muscle
Swyer and RCT Suppository 11/60 (18) 13/53 (25) 0.69 0.25 1.88
Daley, 1953
Vignali and Clinical trial Cream 3/19 (16) 3/15 (20) 0.75 0.09 6.68
Centinalo,
2000
Clifford et al, RCT Suppository 4/20 (20) 7/26 (27) 0.68 0.12 3.29
1996
Progestogen
treatment reduces PI
and S/D of uterine
artery in threatened
miscarriage
24 pregnants 7 pregnants
Autoimmunity
ASA 100 mg/die and
Positive (n=30) 28 (93%) 2 (7%)
Progesterone (n=30)
Number of participants
790
PROMISE trial results: safety outcomes
This is the first well designed Randomized Controlled trial with live birth rate as primary
outcome in this indication
(different from relative risk of miscarriage outcome in previous studies with progesterone 1
or dydrogesterone 2 ).
1 Haas DM, Ramsey PS. Progestogen for preventing miscarriage. Cochrane Database Syst Rev 2013; 10: CD003511.
2 Kumar A, Begum N, Prasad S, Aggarwal S, Sharma S. Oral dydrogesterone treatment during early pregnancy to
prevent recurrent pregnancy loss and its role in modulation of cytokine production: a double-blind, randomized,
parallel, placebo-controlled trial. Fertil Steril 2014;102(5): 1357.e3 1363.e3.
Limitations
Can we make a conclusion that progesterone doesnt
increase live birth rate in TM? NO
Corticosteroids:
5 ~ 20mg / day orally.
Aspirin :
75mg / day orally.
Heparin:
Low molecular weight heparin 2-4000 IU / day,
subcutaneous injection.
PRETERM BIRTH
Preterm parturition syndrome
(following the key features of these syndromes)
Abnormal
Stress-
Allogenic
Nutrition
Recognition
Vascular Allergy
Infection Unknown
ACUTE OBTUSE
WHICH TOOLS?
Strategy in the prevention
Progesterone in women with
previous preterm birth
Main results
36 RCTs included 8523 women
12515 infants
Preterm birth < 37 weeks 10 studies N =1750 RR 0.55 [95% CI 0.42 to 0.74)]
Infant birth weight < 2500 g 4 studies N = 692 RR 0.58 [95% CI 0.42 to 0.79)]
No differential effects in terms of route of administration, time of therapy initiation and dose of
progesterone for majority of outcomes examined.
Vaginal progesterone for the
prevention of recurrent preterm birth
Maher MA, Abdelaziz A, Ellaithy M, Bazeed MF. Acta Obstet Gynecol Scand. 2013;92:215-22.
Progesterone in women with
a short cervix
Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein
K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS; Am J Obstet Gynecol. Feb 2012
Primary Outcome
Hassan SS, Romero R, Vidyadhari D, et al. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31
Is Synthetic Injectable Progesterone
effective for the treatment of a short cervix?
www.google.images.com
2. Available Treatment
Vaginal
Relative risk (fixed) progesterone Placebo Weight Relative risk
Study (95% CI) n/N n/N (%) (95% CI)
REVISION 2016
57
EAPM study group members
Ultrasound Healthcare
Access to Implementation/ Systems/
care Markers Insurance
Ultrasound Coverage
The real voyage of discovery consists not in
seeking new landscapes, but in having new eyes.
Marcel Proust