Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

Last updated: February 14, 2019
Sponsor: Aswan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03781466
aswu/190/18
  • Ages 18-45
  • Female

Study Summary

The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women pregnant in dichorionic twins.

  • Transvaginal sonographic cervical length is <25 mm at 16-20 weeks gestational age.

  • No symptoms, signs or other risk factors for preterm labor

Exclusion

Exclusion Criteria:

  • Age < 18 years or > 45 years.

  • 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.

  • Medical conditions that may lead to preterm delivery.

  • Rupture of membranes.

  • Vaginal bleeding

Study Design

Total Participants: 300
Study Start date:
January 01, 2019
Estimated Completion Date:
March 01, 2021

Study Description

There is a lack of effective, evidence‐based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Connect with a study center

  • Aswan University

    Aswan, 81528
    Egypt

    Active - Recruiting

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