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Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

Information source: Laboratorios Andromaco S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Birth; Fetal Membranes, Premature Rupture

Intervention: Progesterone Cervical Pessary (Drug); Progesterone 200 mg vaginal capsules (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Laboratorios Andromaco S.A.

Overall contact:
Chen Shu-Chen, QF, Phone: +56225948479, Email: schen@andromaco.cl

Summary

Assess the efficacy of 2 Cervical Pessaries containing 6. 3 g and 7. 7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 6/7) and 34 (33 6/7), when the pessary is inserted during weeks 16th and 24th and removed at 36 6/7 weeks in pregnant women at high risk of premature birth.

Clinical Details

Official title: Exploratory Efficacy Study of a Cervical Pessary Sustained Release Progesterone for the Prevention of Preterm Delivery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: prevention of preterm birth

Secondary outcome:

premature rupture of membranes

anatomical features (position and length) of the uterine cervix

Establish the acceptability and tolerance of use of the cerclage pessary

Number of adverse events related with the use of the cerclage pessary

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women with a singleton intrauterine pregnancy, with 10-25 mm cervical length between

gestation weeks 16 and 24, with no prior risk factors.

- Women with a singleton intrauterine pregnancy with 10 mm or more cervical length

between 16 and 24 weeks of gestation, with prior risk factors:

- Prior history of preterm delivery before gestation week 35

- Prior history of premature rupture of membranes before gestation week 35

Exclusion Criteria:

- Pregnancies with:

- Major fetal abnormalities, such as lethal malformations or defects requiring pre

or postnatal surgery; and fetal death before randomization.

- Prior history of premature rupture of membranes or prophylactic cervical

cerclage before study entry.

- Cervical and/or vaginal injuries prior to pessary insertion (e. g., cervical erosion

secondary to trauma, infection, or cancer; vesico-vaginal or recto-vaginal fistulas).

- Unconscious, severely ill or mentally disabled women, or women 16 years of age or

younger

Locations and Contacts

Chen Shu-Chen, QF, Phone: +56225948479, Email: schen@andromaco.cl

Universidad de Chile, Hospital Clínico San Borja Arriarán, Santiago, Chile; Recruiting
Viviana Muñoz, Midwife, Phone: +5629770873, Email: estudiosclinicosidimi@gmail.com
Ariel Fuentes, MD, Principal Investigator

Universidad de Chile, Hospital Barros Luco, Santiago, International 7501257, Chile; Recruiting
Carmen Bravo, Midwife, Phone: +56998831706, Email: heika@gmail.com
Pablo Lavín, MD, Principal Investigator

Additional Information

Related publications:

Dodd JM, Crowther CA, Cincotta R, Flenady V, Robinson JS. Progesterone supplementation for preventing preterm birth: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2005 Jun;84(6):526-33. Review.

Berghella V. Novel developments on cervical length screening and progesterone for preventing preterm birth. BJOG. 2009 Jan;116(2):182-7. doi: 10.1111/j.1471-0528.2008.02008.x. Review.

Jayasooriya GS, Lamont RF. The use of progesterone and other progestational agents to prevent spontaneous preterm labour and preterm birth. Expert Opin Pharmacother. 2009 Apr;10(6):1007-16. doi: 10.1517/14656560902851403 . Review.

Newcomer J. Pessaries for the treatment of incompetent cervix and premature delivery. Obstet Gynecol Surv. 2000 Jul;55(7):443-8. Review.

Arabin B, Halbesma JR, Vork F, Hübener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33.

Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, Juan M, Rodríguez A, Muñoz B, Santacruz B, Bello-Muñoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. Erratum in: Lancet. 2012 May 12;379(9828):1790.

Starting date: August 2013
Last updated: August 24, 2014

Page last updated: August 23, 2015

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