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

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ClinicalTrials.gov Identifier: NCT02225353
Recruitment Status : Completed
First Posted : August 26, 2014
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
Laboratorios Andromaco S.A.
Information provided by (Responsible Party):
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE August 4, 2014
First Posted Date  ICMJE August 26, 2014
Results First Submitted Date  ICMJE March 5, 2018
Results First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE September 2, 2013
Actual Primary Completion Date March 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2018)
Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation [ Time Frame: Up to 36 weeks of gestational age ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2014)
prevention of preterm birth [ Time Frame: Up to 36 weeks of gestational age ]
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 6/7) and 34 (33 6/7), when the pessary is inserted between weeks 16 and 24 and removed at 36 6/7 weeks in pregnant women at high risk of premature delivery.
Change History Complete list of historical versions of study NCT02225353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2018)
  • Number of Participants With Premature Rupture of Membranes [ Time Frame: Up to 36 weeks of gestational age ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ Time Frame: Up to 36 weeks of gestational age ]
    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 [ Time Frame: Up to 36 weeks of gestational age ]
    The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2014)
  • premature rupture of membranes [ Time Frame: Up to 36 weeks of gestational age ]
  • anatomical features (position and length) of the uterine cervix [ Time Frame: up to 36 weeks of gestational age ]
    during pregnant controls will be assessed anatomical features (position and length) of the uterine cervix and will be compared between term and preterm births
  • Establish the acceptability and tolerance of use of the cerclage pessary [ Time Frame: Up to 36 weeks of gestational age ]
    A questionnaire will be used to compared acceptability & tolerance in the insertion, during pregnancy and during the extraction of cerclage pessary.
  • Number of adverse events related with the use of the cerclage pessary [ Time Frame: Up to 36 weeks of gestational age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Official Title  ICMJE 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.
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:

  1. preterm birth prior to 35 (34 weeks and 6 days) weeks of gestation;
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Preterm Birth
Intervention  ICMJE
  • Drug: Progesterone Cervical Pessary 6.3 g
    Progesterone Cervical Pessary low dose
  • Drug: Progesterone 200 mg vaginal capsules
    Progesterone 200 mg vaginal capsules daily
    Other Name: Hormoral (Trade Mark) Capsules
  • Drug: Progesterone Cervical Pessary 7.7 g
    Progesterone Cervical Pessary high dose
Study Arms  ICMJE
  • Experimental: Progesterone Cervical Pessary 6.3 g
    90 pregnant women with Progesterone Cervical Pessary
    Intervention: Drug: Progesterone Cervical Pessary 6.3 g
  • Experimental: Progesterone Cervical Pessary 7.7 g
    90 pregnant women with Progesterone Cervical Pessary
    Intervention: Drug: Progesterone Cervical Pessary 7.7 g
  • Active Comparator: Progesterone 200 mg vaginal capsules
    90 pregnant women using Progesterone 200 mg vaginal capsules daily
    Intervention: Drug: Progesterone 200 mg vaginal capsules
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
271
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2014)
180
Actual Study Completion Date  ICMJE March 13, 2017
Actual Primary Completion Date March 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02225353
Other Study ID Numbers  ICMJE EC12012/10IEI-9339
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Grünenthal GmbH
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Laboratorios Andromaco S.A.
Investigators  ICMJE
Study Director: Grünenthal Study Director Grünenthal GmbH
PRS Account Grünenthal GmbH
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP