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Progesterone and preterm birth
prevention
translating clinical trials
Mentor:
Dr. Nora Al-Qahtani
Consultant Ob/Gyn
KSMC, Maternity Hospital
Presenter:
Dr. Hend M. Hamido
MBBCh, MSc Ob/Gyn, Egypt
KSMC, Maternity Hospital
• Complicates 1 in 8 births in developed countries.
• Accounts for more than 85% of all perinatal
morbidity and mortality, responsible for:
Spong, Obst Gynecol 2007
• Major causes of preterm birth
Although the ability of obstetric care
providers to identify women at high risk
for preterm birth has improved, due to
introduction of TV cervical length
measurement, and cervico-vaginal fetal
fibronectin testing…
Efforts to prevent preterm
birth, have been largely
unsuccessful.
• Steroid Hormone
• Isolated in 1934 from the corpus luteum
• ƒNatural or Synthetic formulations (Oral, IM,
and Vaginal )
• ƒUsed for:
• • Hormonal supplementation
• • Replacement
• • Contraception
• Synthetic progesterone:
• HYDROXYPROGESTERONE CAPROATE
(17P)
• FDA approved 3/Feb/2011
• The only FDA approved medication to reduce
the risk of PTB in certain situations.
Rational behind use of progesterone
to prevent preterm birth
• In the 1st
trimester, progesterone produced by the
corpus luteum is critical to the maintenance of early
pregnancy, until the placenta takes over this
function at 7-9 wks of gestation.
• Removal of the source of progesterone (CL), or
administration of progesterone receptor antagonists,
readily induces abortion before 7 wks of gestation.
• Its role in later pregnancy is less clear, it maybe
important to maintain uterine quiescence, by
limiting production of stimulatory prostaglandins,
and inhibiting the expression of contraction
associated protein genes (oxytocins, prostaglandins,
and gap junctions) in the myometrium.
The
hypoThesi
s
Myometrial activity associated with preterm labor
results mainly from loss of the inhibitory effect of
pregnancy on the myometrium, rather than an active
process of release of uterine stimulants.
The onset of labor, both at term and preterm is
associated with, a functional withdrawal of
progesterone activity at the uterine level.
Exogenous progesterone, will
offset withdrawal and preterm
birth
Let’s examine the evidence…
• However, a larger trial (600+), history of PTB,
vaginal progesterone gel 90 mg daily, starting
at 18-23 wks, didn’t find similar results.
• So, let’s translate all these trials into clinical
practice
Eligibility for
17P:
•History of
spontaneous PTB
<37 wks gestation.
•Singleton
pregnancy.
•Initiate treatment
between 16 wks
and 20 wks 6days
Exclusion:
•Known fetal
anomaly.
•Current or
planned cervical
cerclage.
•Hypertension.
•Seizure disorder.
17P is not for
women with:
•Multi fetal
pregnancy.
•Short cervix and
NO prior PTB
•Previous medically
indicated PTB
Level I and III evidence
Level A recommendation
There is insufficient evidence
to recommend progesterone in
singleton gestation, with no
prior PTB, and unknown CL
Level I evidence
Level A recommendation
In singleton gestation, no prior SPTB,
and TVU CL ≤ 20 mm, at ≤ 24 wks.
Vaginal progesterone (90 mg gel or
200 mg supp.) is associated with
reduction of PTB, and perinatal
mortality and morbidity
Level I and III evidence
Level B recommendation
Universal TVU CL
screening of singleton
gestation without history of
PTB is subject of debate.
Level I and III evidence
Level A & B recommendation
In singleton gestation with prior
SPTB at 20-36W+6 days, 250 mg
IM weekly of 17P to start at 16-20
weeks till 37 weeks
Level I, II, and III evidence
Level B recommendation
Progesterone is not
associated with prevention
of PTB in multiple
gestation, PTL, or PPROM
These recommendations coincide
with those from uptodate,
however…
Progesterone in preterm birth
Progesterone in preterm birth
Progesterone in preterm birth
Progesterone in preterm birth

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Progesterone in preterm birth

  • 1. Progesterone and preterm birth prevention translating clinical trials Mentor: Dr. Nora Al-Qahtani Consultant Ob/Gyn KSMC, Maternity Hospital Presenter: Dr. Hend M. Hamido MBBCh, MSc Ob/Gyn, Egypt KSMC, Maternity Hospital
  • 2.
  • 3. • Complicates 1 in 8 births in developed countries.
  • 4. • Accounts for more than 85% of all perinatal morbidity and mortality, responsible for: Spong, Obst Gynecol 2007
  • 5. • Major causes of preterm birth
  • 6.
  • 7. Although the ability of obstetric care providers to identify women at high risk for preterm birth has improved, due to introduction of TV cervical length measurement, and cervico-vaginal fetal fibronectin testing… Efforts to prevent preterm birth, have been largely unsuccessful.
  • 8. • Steroid Hormone • Isolated in 1934 from the corpus luteum • ƒNatural or Synthetic formulations (Oral, IM, and Vaginal ) • ƒUsed for: • • Hormonal supplementation • • Replacement • • Contraception
  • 9. • Synthetic progesterone: • HYDROXYPROGESTERONE CAPROATE (17P) • FDA approved 3/Feb/2011 • The only FDA approved medication to reduce the risk of PTB in certain situations.
  • 10. Rational behind use of progesterone to prevent preterm birth
  • 11. • In the 1st trimester, progesterone produced by the corpus luteum is critical to the maintenance of early pregnancy, until the placenta takes over this function at 7-9 wks of gestation. • Removal of the source of progesterone (CL), or administration of progesterone receptor antagonists, readily induces abortion before 7 wks of gestation. • Its role in later pregnancy is less clear, it maybe important to maintain uterine quiescence, by limiting production of stimulatory prostaglandins, and inhibiting the expression of contraction associated protein genes (oxytocins, prostaglandins, and gap junctions) in the myometrium.
  • 13. Myometrial activity associated with preterm labor results mainly from loss of the inhibitory effect of pregnancy on the myometrium, rather than an active process of release of uterine stimulants. The onset of labor, both at term and preterm is associated with, a functional withdrawal of progesterone activity at the uterine level. Exogenous progesterone, will offset withdrawal and preterm birth
  • 14. Let’s examine the evidence…
  • 15.
  • 16.
  • 17.
  • 18. • However, a larger trial (600+), history of PTB, vaginal progesterone gel 90 mg daily, starting at 18-23 wks, didn’t find similar results.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27. • So, let’s translate all these trials into clinical practice
  • 28. Eligibility for 17P: •History of spontaneous PTB <37 wks gestation. •Singleton pregnancy. •Initiate treatment between 16 wks and 20 wks 6days Exclusion: •Known fetal anomaly. •Current or planned cervical cerclage. •Hypertension. •Seizure disorder. 17P is not for women with: •Multi fetal pregnancy. •Short cervix and NO prior PTB •Previous medically indicated PTB
  • 29.
  • 30. Level I and III evidence Level A recommendation There is insufficient evidence to recommend progesterone in singleton gestation, with no prior PTB, and unknown CL
  • 31. Level I evidence Level A recommendation In singleton gestation, no prior SPTB, and TVU CL ≤ 20 mm, at ≤ 24 wks. Vaginal progesterone (90 mg gel or 200 mg supp.) is associated with reduction of PTB, and perinatal mortality and morbidity
  • 32. Level I and III evidence Level B recommendation Universal TVU CL screening of singleton gestation without history of PTB is subject of debate.
  • 33. Level I and III evidence Level A & B recommendation In singleton gestation with prior SPTB at 20-36W+6 days, 250 mg IM weekly of 17P to start at 16-20 weeks till 37 weeks
  • 34. Level I, II, and III evidence Level B recommendation Progesterone is not associated with prevention of PTB in multiple gestation, PTL, or PPROM
  • 35.
  • 36. These recommendations coincide with those from uptodate, however…