New Progesterone Guideline for Preterm labor and incidental shortened cervix
Progesterone and Preterm birth Prevention 2 SEPARATE INDICATIONS INDICATIONS DETERMINE CHOICE OF THERAPY MAY 2012 17alpha-hydroxyprogesterone caproate(17-P) VAGINAL GEL 90 MG OR 200-mg SUPPOSITORY
SAFETY• Follow-up, at a mean of 4 years, of 278 children randomized in the largest RCT evaluating 17P for prevention of recurrent PTB revealed no differences compared to placebo Regarding:• Physical examination• Health status• Performance (motor, problem solving, personal, social).• Obstet Gynecol 2007;110: 865-72. NICHD
Current Society for Maternal-Fetal Medicine recommendationsregarding use of progestogens for prevention of preterm birth• Singletons with prior SPTB 17P 250 mg IM weekly from 16-20 wk until 36 wk• Singletons without prior SPTB but CL 20 mm at 24 wk Vaginal progesterone 90-mg gel or 200-mg suppository daily from diagnosis of short CL until 36• Multiple gestations No evidence of effectiveness
Previous PTD < 36 wks Second Trimester Loss ( 12-22wks)• PTD 16 TO 36 weeks Start 17 P @ 16 weeks continue until 36 completed weeks.• Serial cervical lengths start @ 16 weeks & continue every 2 weeks UNTIL 24 0/7 WEEKS. CERVICAL LENGTH If >/= 35 mm continue every two weeks until 24 0/7 weeks.• If CERVIVCAL LENGTH is 25-34 mm continue serial cervical lengths every 1 WEEK vs 2 weeks UNTIL 24 0/7 WEEKS• If cervix is < 25 mm these patients may benefit from cerclage up to 24 0/7 weeks. ( OWEN RCT 2009 AJOG). If < 15 mm they will gain the most benefit from cerclage.• If idiopathic (ie c/w incompetent cervix) previous second trimester loss from 12-22 weeks these patients should have strong consideration for history indicated cerclage.
Incidental Short Cervix No previous PTB• Singleton gestations and TVU CL 15 mm or less at 20-25 weeks, vaginal progesterone 200 mg nightly started at 24 weeks until 34 weeks• IN women without prior PTB benefit of 200 mg progesterone in preventing PTB < 34 weeks (RR, 0.54; 95% CI, 0.34 – 0.88).• IF TVU CL 15 , the number of women needed to treat to prevent 1 PTB < 34 weeks is about 1 IN 7FONSECA et.al;N Engl J Med 2007;357:462-9.
Incidental Short Cervix No previous PTB • Singleton gestations without PTB and TVU CL 10 mm -20 mm at vaginal progesterone 90-mg gel daily started at 20-23 6/7 weeks until 36 6/7 weeks preventing PTB < 33 weeks (8% vs 15%; RR,0.50; 95% CI,0.27– 0.90) • Once a TVU CL 10-20 mm is identified, the number needed to treat to prevent 1 PTB < 33 weeks is about 1 IN 14.Hassan et.al;Ultrasound Obstet Gynecol 2011;38:18.
Incidental Short Cervix No previous PTB • In a metaanalysis, including 554 singleton gestations, with no prior PTB, and TVU CL < 25 mm < 25 weeks • Vaginal progesterone 90 mg was associated with a significant reduction in PTB < 33 weeks (RR, 0.60; 95% CI,0.39 – 0.92)Romero et.al;Am J Obstet Gynecol 2012;206:124.NIH
200 mg Suppository OR 90mg GEL No clearly Superior Therapy• FIRST INDICATION• NO prior HISTORY OF PTB• INCIDENTAL SHORT CERVIX = 10 mm-20 mm TVCL• 20 mm is 5th percentile• 25 mm is 10th percentile• Vaginal Progesterone is associated with reduction in PTB and composite perinatal morbidity and mortality.• Based on these results if a TVU CL 10-20 mm is identified at 24 weeks OR LESS• Vaginal Progesterone ( 90 mg GEL OR 200 mg suppository) can be offered for prevention of PTB.• RR ~0.55 FOR PTB PREVENTION <34 WEEKS • SMFM Clinical Guideline MAY 2012
17P FOR PRIOR PTB • Although limited data is available comparing the different preparations of progestogens • CURRENTLY stronger evidence of effectiveness for 17P VS. vaginal progesterone, IN WOMEN WITH PRIOR PTB , based on the 2 largest trials. • Therefore, 17P 250 mg IM weekly starting at 16-20 weeks until 36 weeks should be recommended to women with singleton gestations and Prior PTB @ 20-36 6/7 weeks. • Consider cerclage for cervical length < 25 mm.O’brien et.al; Ultrasound Obstet Gynecol 2007;30:687-96Meis et.al; N Engl J Med 2003;348:2379
INCIDENTL SHORT CERVIX </= TO 20 MM < 24 WEEKS• Singletons without prior PTB but WITH Vaginal CL </=20 mm at < 24 wk• Progesterone 90-mg gel• Micronized progesterone 200-mg suppository• Daily from diagnosis until 36 WEEKS• < 10 MM CONSULT MFM• SMFM Clinical Guideline MAY 2012