The Vaginal Progesterone and Cerclage
Condition: Abortion
Study type: Interventional
Phase: Phase 2

Summary: 
      Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be
      lost in the second trimester, which is much lower than in the first trimester. Once a
      pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.

      Congenital fetal abnormalities and maternal anatomic factors as immunologic factors,
      infection, and thrombophilia should be considered; however, a reason and its result
      connection may be difficult to be established.

      Cervical incompetence means that the cervix is weak and unable to remain closed during the
      pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in
      maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to
      ascending infection may be more important.

      Cervical cerclage is performed usually in women with a history of mid-trimester abortion or
      spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing
      recurrent loss.

      Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians
      despite the absence of a well-defined population for whom there is clear evidence of benefit.
      Furthermore, there is little consensus on the optimal cerclage technique and timing and type
      of suture placement.

      The Progesterone is known to have an inhibitory action on uterine contractility and is
      thought to play a main role in the maintenance of pregnancy until term. Progesterone is also
      able to modify the ultrastructural organisation of the myometrium by inhibiting the gap
      junctions, and preventing muscular contraction.

      Different routes of administration of progesterone have been described in the literature.
      These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and
      daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.

      A recently published Cochrane review further confirmed the beneficial effects of progesterone
      in infant health following administration in women considered to be at increased risk of
      preterm birth due either to past history of preterm birth or when a short cervix was
      identified on ultrasound.

      However; most of these published studies have been conducted to test the effect of
      progestational agents for the prevention of preterm labor not miscarriage.

      Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler
      ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth
      retardation and fetal anemia, and it plays an important role in managing of these conditions
    


Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): 400mg progesterone pessaries
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention