Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    200
  • sponsor
    Aswan University Hospital
Updated on 23 January 2021

Summary

The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Description

The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix 25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome

Details
Condition Twin; Pregnancy, Affecting Fetus or Newborn
Treatment progesterone 400mg, progesterone 200mg, placebo to progesterone 200mg, placebo to progesterone 400mg
Clinical Study IdentifierNCT03781674
SponsorAswan University Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women pregnant in dichorionic twins
Transvaginal sonographic cervical length is <25 mm at 18-22 weeks gestational age
No symptoms, signs or other risk factors for preterm labor

Exclusion Criteria

Known allergy or contraindication (relative or absolute) to progesterone therapy
Monochorionic twins
Known major fetal structural or chromosomal abnormality
Intrauterine death of one fetus or death of both fetuses
Fetal reduction in the current pregnancy
Cervical cerclage in the current pregnancy
Medical conditions that may lead to preterm delivery
Rupture of membranes
Vaginal bleeding
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