Phase 2
N=271
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Preterm Birth
Bottom Line
View on ClinicalTrials.gov: NCT02225353 ↗Enrolled (actual)
271
Serious AEs
38.4%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation — 73; 71; 67; 66 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Progesterone Cervical Pessary 6.3 g (Drug); Progesterone 200 mg vaginal capsules (Drug); Progesterone Cervical Pessary 7.7 g (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Grünenthal GmbH
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation |
73; 71; 67; 66; 64; 61 | — |
| SECONDARY Number of Participants With Premature Rupture of Membranes |
1; 4; 3 | — |
| SECONDARY Anatomical Feature: Length of the Uterine Cervix |
28.69; 29.62; 28.44; 28.51; 30.34; 29.29 | — |
| SECONDARY Anatomical Feature: Position of the Uterine Cervix |
114.54; 112.59; 112.85; 111.47; 115.02; 109.74 | — |
| SECONDARY Acceptability and Tolerance of Use of the Cerclage Pessary |
— | — |
| SECONDARY Number of Adverse Events Related With the Use of Treatment |
31; 22; 2; 1; 2; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02225353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.