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

NCT02225353 | Completed Phase 2 Results DMC

• 1 other identifier: EC12012/10IEI-9339
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 4

Brief 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 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.

Conditions

Preterm Birth

Keywords

Preterm birth; Short cervix; Cervical Pessaries; Progesterone

Outcome Measures

Primary Outcomes (1)

• Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation

  To assess the efficacy of Cerclage Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous parturition before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted between weeks 16 and 24 and removed at 36 weeks and 6 days in pregnant women at high risk of premature delivery. For the purpose of this analysis, pregnancies were no longer considered as high risk for the event if delivery occurred at week 34 of gestation and beyond. Gestational age was determined by the last menstruation date and were confirmed by measurement of the craniocaudal length obtained in the first trimester ultrasound, or by measurement of the cephalic circumference in the second trimester ultrasound predominating the actual date of the last menstrual period. The number of participants not giving birth before 32 weeks and 34 weeks are reported.

  Up to 36 weeks of gestational age

Secondary Outcomes (5)

• Number of Participants With Premature Rupture of Membranes

  Up to 36 weeks of gestational age

• Anatomical Feature: Length of the Uterine Cervix

  Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.

• Anatomical Feature: Position of the Uterine Cervix

  Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.

• Acceptability and Tolerance of Use of the Cerclage Pessary

  Up to 36 weeks of gestational age

• Number of Adverse Events Related With the Use of Treatment

  Up to 36 weeks of gestational age

Study Arms (3)

Progesterone Cervical Pessary 6.3 g

EXPERIMENTAL

90 pregnant women with Progesterone Cervical Pessary

Drug: Progesterone Cervical Pessary 6.3 g

Progesterone Cervical Pessary 7.7 g

EXPERIMENTAL

90 pregnant women with Progesterone Cervical Pessary

Drug: Progesterone Cervical Pessary 7.7 g

Progesterone 200 mg vaginal capsules

ACTIVE COMPARATOR

90 pregnant women using Progesterone 200 mg vaginal capsules daily

Drug: Progesterone 200 mg vaginal capsules

Interventions

Progesterone Cervical Pessary 6.3 g DRUG

Progesterone Cervical Pessary low dose

Progesterone Cervical Pessary 6.3 g

Progesterone 200 mg vaginal capsules DRUG

Progesterone 200 mg vaginal capsules daily

Also known as: Hormoral (Trade Mark) Capsules

Progesterone 200 mg vaginal capsules

Progesterone Cervical Pessary 7.7 g DRUG

Progesterone Cervical Pessary high dose

Progesterone Cervical Pessary 7.7 g

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a single pregnancy and a cervical length of 10 mm - 25 mm between 16 and 24 weeks of gestation, without any previous factors.
• Women with a single pregnancy with 10 mm or more cervical length between 16 and 24 weeks of gestation, and pre-existing risk factors risk factors for preterm birth:
• Previous preterm birth before week 35.
• Previous rupture of membranes before week 35

You may not qualify if:

• Pregnancies with:
• History of rupture of membranes or prophylactic cerclage before study entry.
• Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).
• Unconscious, severely ill or mentally disabled patients, or under 16 years of age.
• Patients for whom use of progesterone is contraindicated.
• Patients with history of thrombosis.

Sponsors & Collaborators

• Grünenthal GmbH: lead
• Laboratorios Andromaco S.A.: collaborator

Study Sites (4)

Universidad de Chile, Hospital Barros Luco

Santiago, 7501257, Chile

Location

Complejo Asistencial Dr. Sótero del Río (CASR)

Santiago, Chile

Location

Unidad de Alto Riesgo Obstétrico y Medicina Perinatal y en el Centro Perinatal Oriente (CERPO), Hospital Santiago Oriente, Dr. Luis Tisné Brousse

Santiago, Chile

Location

Universidad de Chile, Hospital Clínico San Borja Arriarán

Santiago, Chile

Location

Related Publications (6)

• 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. doi: 10.1111/j.0001-6349.2005.00835.x.

  PMID: 15901258 BACKGROUND

• 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.

  PMID: 19076950 BACKGROUND

• 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.

  PMID: 19351272 BACKGROUND

• Newcomer J. Pessaries for the treatment of incompetent cervix and premature delivery. Obstet Gynecol Surv. 2000 Jul;55(7):443-8. doi: 10.1097/00006254-200007000-00023.

  PMID: 10885649 BACKGROUND

• Arabin B, Halbesma JR, Vork F, Hubener 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. doi: 10.1515/JPM.2003.017.

  PMID: 12747228 BACKGROUND

• Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz 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.

  PMID: 22475493 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone; Capsules

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Grünenthal GmbH

clinical-trials@grunenthal.com

+49 241 569 3223

Study Officials

• Grünenthal Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 26, 2014
• Study Start: September 2, 2013
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (4)