N/A
N=385
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Preterm Birth
Bottom Line
View on ClinicalTrials.gov: NCT00706264 ↗Enrolled (actual)
385
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Spontaneous Delivery Before 34 Completed Weeks — 51; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silicon ring (Arabin Pessary) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spontaneous Delivery Before 34 Completed Weeks |
51; 12 | — |
| SECONDARY Birthweight Less Than 1500 g |
26; 9 | — |
| SECONDARY Birthweight Less Than 2500 g |
56; 17 | — |
| SECONDARY Intrauterine Fetal Demise |
0; 0 | — |
| SECONDARY Neonatal Death |
1; 0 | — |
| SECONDARY Intraventricular Haemorrhage |
2; 0 | — |
| SECONDARY Respiratory Distress Syndrome |
23; 5 | — |
| SECONDARY Retinopathy of Prematurity |
2; 0 | — |
| SECONDARY Necrotising Enterocolitis |
2; 0 | — |
| SECONDARY Treatment for Sepsis |
12; 3 | — |
| SECONDARY Composite Adverse Outcomes |
30; 5 | — |
| SECONDARY Spontaneous Delivery Before 28 Completed Weeks |
16; 4 | — |
| SECONDARY Any Delivery Before 34 Completed Weeks |
53; 14 | — |
| SECONDARY Spontaneous Delivery Before 37 Completed Weeks |
113; 41 | — |
| SECONDARY Gestational Age at Delivery |
34.9; 37.7 | — |
| SECONDARY Use of Tocolysis |
101; 64 | — |
| SECONDARY Use of Antenatal Steroids |
121; 80 | — |
| SECONDARY Chorioamnionitis |
6; 5 | — |
| SECONDARY Vaginal Bleeding |
9; 7 | — |
| SECONDARY Preterm Premature Rupture of Membranes |
17; 3 | — |
| SECONDARY Cesarean Delivery |
40; 41 | — |
| SECONDARY Vaginal Discharge |
87; 190 | — |
| SECONDARY Pessary Repositioning Without Removal |
0; 27 | — |
| SECONDARY Pessary Withdrawal |
0; 1 | — |
Summary
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.
Eligibility Criteria
Inclusion Criteria
- Singleton pregnancy
- Minimal age of 18 years
Exclusion Criteria
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- SROM at the time of randomization
- Cervical cerclage in situ
- Active vaginal bleeding
- Previous cone biopsy or cerclage
- Major uterine structural anomalies
- Placenta previa
Data sourced from ClinicalTrials.gov (NCT00706264). 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.