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Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery (PCP002)

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Progesterone Cervical Pessary 6.3 g
Progesterone 200 mg vaginal capsules
Progesterone Cervical Pessary 7.7 g
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Preterm birth, Short cervix, Cervical Pessaries, Progesterone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancies with:

    • Major fetal abnormalities, such as lethal malformations or malformations requiring pre- or post-natal surgery; and fetal death before inclusion into the study.
    • 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.

Sites / Locations

  • Universidad de Chile, Hospital Barros Luco
  • Complejo Asistencial Dr. Sótero del Río (CASR)
  • Unidad de Alto Riesgo Obstétrico y Medicina Perinatal y en el Centro Perinatal Oriente (CERPO), Hospital Santiago Oriente, Dr. Luis Tisné Brousse
  • Universidad de Chile, Hospital Clínico San Borja Arriarán

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Progesterone Cervical Pessary 6.3 g

Progesterone Cervical Pessary 7.7 g

Progesterone 200 mg vaginal capsules

Arm Description

90 pregnant women with Progesterone Cervical Pessary

90 pregnant women with Progesterone Cervical Pessary

90 pregnant women using Progesterone 200 mg vaginal capsules daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Premature Rupture of Membranes
A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician.
Anatomical Feature: Length of the Uterine Cervix
During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed.
Anatomical Feature: Position of the Uterine Cervix
During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus.
Acceptability and Tolerance of Use of the Cerclage Pessary
A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary. Data from this questionnaire was not collected.
Number of Adverse Events Related With the Use of Treatment
The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness.

Full Information

First Posted
August 4, 2014
Last Updated
October 20, 2018
Sponsor
Grünenthal GmbH
Collaborators
Laboratorios Andromaco S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02225353
Brief Title
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Acronym
PCP002
Official Title
A Randomized, Open-Label, Controlled, Multi-Center Study on the Efficacy of a Sustained Release Progesterone Cerclage Cervical Pessary at Doses of 6.3 g or 7.7 g for the Prevention of Preterm Birth and a Maximum Duration of 20 Weeks.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2, 2013 (Actual)
Primary Completion Date
March 13, 2017 (Actual)
Study Completion Date
March 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
Collaborators
Laboratorios Andromaco S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Participant selection will be performed by screening the general population of pregnant women with single fetus monitored by the Hospital Healthcare Network, to investigate by serial transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women with a single fetus and cervical length ≥10 mm presenting one or more of the following risk factors: preterm birth prior to 35 (34 weeks and 6 days) weeks of gestation; premature rupture of membranes prior to 35 (34 and 6 days) weeks of gestation. After insertion of the pessary or beginning of the administration with vaginal progesterone capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be monitored every 4 weeks at the most or more often, if the site has established so as a control standard. After 28 weeks, patients should be monitored every 2 weeks. The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be compared between the control group and the 2 groups with the pessaries containing different doses of progesterone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm birth, Short cervix, Cervical Pessaries, Progesterone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone Cervical Pessary 6.3 g
Arm Type
Experimental
Arm Description
90 pregnant women with Progesterone Cervical Pessary
Arm Title
Progesterone Cervical Pessary 7.7 g
Arm Type
Experimental
Arm Description
90 pregnant women with Progesterone Cervical Pessary
Arm Title
Progesterone 200 mg vaginal capsules
Arm Type
Active Comparator
Arm Description
90 pregnant women using Progesterone 200 mg vaginal capsules daily
Intervention Type
Drug
Intervention Name(s)
Progesterone Cervical Pessary 6.3 g
Intervention Description
Progesterone Cervical Pessary low dose
Intervention Type
Drug
Intervention Name(s)
Progesterone 200 mg vaginal capsules
Other Intervention Name(s)
Hormoral (Trade Mark) Capsules
Intervention Description
Progesterone 200 mg vaginal capsules daily
Intervention Type
Drug
Intervention Name(s)
Progesterone Cervical Pessary 7.7 g
Intervention Description
Progesterone Cervical Pessary high dose
Primary Outcome Measure Information:
Title
Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation
Description
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.
Time Frame
Up to 36 weeks of gestational age
Secondary Outcome Measure Information:
Title
Number of Participants With Premature Rupture of Membranes
Description
A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician.
Time Frame
Up to 36 weeks of gestational age
Title
Anatomical Feature: Length of the Uterine Cervix
Description
During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed.
Time Frame
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.
Title
Anatomical Feature: Position of the Uterine Cervix
Description
During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus.
Time Frame
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.
Title
Acceptability and Tolerance of Use of the Cerclage Pessary
Description
A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary. Data from this questionnaire was not collected.
Time Frame
Up to 36 weeks of gestational age
Title
Number of Adverse Events Related With the Use of Treatment
Description
The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness.
Time Frame
Up to 36 weeks of gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnancies with: Major fetal abnormalities, such as lethal malformations or malformations requiring pre- or post-natal surgery; and fetal death before inclusion into the study. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grünenthal Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Chile, Hospital Barros Luco
City
Santiago
ZIP/Postal Code
7501257
Country
Chile
Facility Name
Complejo Asistencial Dr. Sótero del Río (CASR)
City
Santiago
Country
Chile
Facility Name
Unidad de Alto Riesgo Obstétrico y Medicina Perinatal y en el Centro Perinatal Oriente (CERPO), Hospital Santiago Oriente, Dr. Luis Tisné Brousse
City
Santiago
Country
Chile
Facility Name
Universidad de Chile, Hospital Clínico San Borja Arriarán
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15901258
Citation
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.
Results Reference
background
PubMed Identifier
19076950
Citation
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.
Results Reference
background
PubMed Identifier
19351272
Citation
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.
Results Reference
background
PubMed Identifier
10885649
Citation
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.
Results Reference
background
PubMed Identifier
12747228
Citation
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.
Results Reference
background
PubMed Identifier
22475493
Citation
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. Erratum In: Lancet. 2012 May 12;379(9828):1790.
Results Reference
background

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

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